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COVID-19 clinical trials at University of California Health

109 in progress, 58 open to eligible people

Showing trials for
  • A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19

    open to eligible people ages 18 years and up

    COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis. This proinflammatory cascade is activated when viral-mediated cell damage occurs in the lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9 (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. These damage-associated molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and result in additional release of pro-inflammatory molecules. Several recent studies have shown that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both neutrophil count and disease severity. Taken together the DAMP-TLR4 interaction forms a central axis in the innate immune system and is a key driver of the pathological inflammation observed in COVID-19. We hypothesis that targeting the initial step in the signalling pathways of these DAMPs in innate immunity offers the best hope for controlling the exaggerated host response to SARS-CoV-2 infection. EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality.

    at UCSF

  • A Research Study of Capricor's IV Drug in Hospitalized Patients with COVID-19

    open to eligible people ages 18 years and up

    This is a randomized, double-blind, placebo-controlled study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures.

    at UC Davis

  • A Study of COVID-19 in Cancer Patients

    open to all eligible people

    This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • A Study of Investigational Therapeutics for Hospitalized Patients with COVID-19 ("ACTIV 3")

    open to eligible people ages 18 years and up

    This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

    at UCLA UCSF

  • A Study of Remdesivir and other Medications for the Treatment of COVID-19 in Critically Ill Patients

    open to eligible people ages 18 years and up

    The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.

    at UC Davis UCSF

  • A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

    “By signing up, you can help answer some of the biggest questions for getting back to life safely”

    open to eligible people ages 18-29

    The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine.

    at UC Davis UCSD

  • A Study of the Drug Isavuconazole to Prevent COVID-19-associated Pulmonary Aspergillosis

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    open to eligible people ages 18 years and up

    The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the ICU (intensive care unit) with severe COVID-19 infection. The investigators will perform an interventional, double-blinded, randomized-controlled, multi-center study in patients with severe COVID-19 infection admitted to the ICU. Patients will be randomized to the isavuconazole prophylaxis plus standard of care (SOC) group or the placebo plus SOC group. Participants will receive isavuconazole or placebo for up to 28 days or until discharge from the hospital (whichever occurs first).

    at UC Davis UC Irvine UCSD

  • A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)

    open to eligible people ages 18 years and up

    This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.

    at UC Irvine

  • ACTIV-2: A Study for Outpatients With COVID-19

    open to eligible people ages 18 years and up

    Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

    open to eligible people ages 18 years and up

    This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

    at UCLA UCSF

  • Acupressure for COVID-19 Related Quality of Life and Stress

    open to eligible people ages 18 years and up

    This study is being conducted to evaluate the efficacy of acupressure in promoting health and well-being among healthcare workers during the COVID-19 pandemic. The investigators hypothesize that providing participants with a remote and standardized self-acupressure training program will improve HRQOL and the perception of stress. In the event that the study demonstrates acupressure to be safe and effective for this indication, the training could be scaled up and deployed at low-cost nationally and internationally.

    at UCLA

  • Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4)

    open to eligible people ages 18 years and up

    This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients

    at UCLA UCSD UCSF

  • Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)

    open to eligible people ages 18 years and up

    In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine Zero (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10-20ml (according to the rinse instructions) of the assigned solutions 4 times per day, for 30-60 seconds, for 4 weeks.

    at UCSF

  • Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

    open to eligible people ages 18 years and up

    The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

    at UC Irvine

  • ASCO Survey on COVID-19 in Oncology (ASCO) Registry

    open to all eligible people

    The American Society of Clinical Oncology (ASCO) Survey on Coronavirus 2019 (COVID-19) in Oncology Registry (ASCO Registry) aims to help the cancer community learn more about the patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry is designed to collect both baseline and follow-up data on how the virus impacts cancer care and cancer patient outcomes during the COVID-19 pandemic and into 2021.

    at UCSF

  • Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic

    open to eligible females ages 18 years and up

    Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.

    at UCSF

  • Asymptomatic SARS-CoV-2 Detection in Children

    open to eligible people ages up to 18 years

    The primary objective of this study is quantify the transmission risk posted by SARS-CoV-2 in pre/asymptomatic infected children in order to inform the public health response to the COVID-19 pandemic.

    at UCSD

  • Chinese Herbal Formula for COVID-19

    open to eligible people ages 18 years and up

    This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.

    at UCLA UCSD

  • COVID-19 Recovered Volunteer Research Participant Pool Registry

    open to eligible people ages 18 years and up

    This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.

    at UCLA

  • COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

    open to eligible people ages 18 years and up

    A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

    at UCSF

  • COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations

    open to eligible people ages 12 years and up

    Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders

    at UCLA

  • DISulfiram for COvid-19 (DISCO) Trial

    open to eligible people ages 18 years and up

    Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will study oral disulfiram given for 5 consecutive days (1000 mg/day in cohort 1; 2000 mg/day in cohort 2) in 60 symptomatic COVID+ individuals in a randomized (2:1) randomized, double blind placebo-controlled trial evaluating disulfiram's effect on COVID-19 symptom severity, SARS-CoV-2 viral load, and biomarkers of inflammation and pyroptosis (aberrant pro-inflammatory cell death) over 31 days.

    at UCSF

  • Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

    open to eligible people ages 18-100

    The study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

    at UC Irvine

  • Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness

    open to eligible people ages 18 years and up

    This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). In a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, COVID-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. A sub-sample of 40 participants living in both PB-PSH and SS-PSH will be qualitatively interviewed longitudinally to help contextualize quantitative findings. Focus groups will also be conducted with providers of PSH and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining COVID-19 related prevention practices while maintaining a continuity of care.

    at UCLA

  • Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth

    open to eligible people ages 18 years and up

    This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.

    at UCSF

  • Imaging Immune Activation in COVID-19

    open to eligible people ages 18 years and up

    This is a single center, single arm exploratory imaging study involving up to two intravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed by whole-body PET-CT imaging in participants with convalescent COVID-19. Up to 20 participants will be enrolled over an accrual period of approximately 24 months. Each participant will undergo one PET-CT scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG in order to determine the tissue distribution of tracer in pariticpants with recent SARS-CoV-2 infection. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.

    at UCSF

  • Immune Modulators for Treating COVID-19

    open to eligible people ages 18 years and up

    ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

    at UC Irvine UCLA

  • Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    open to eligible people ages 18 years and up

    This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer that begin in cells of the immune system. CLL/SLL and the medications used to treat these conditions may change the way vaccines work in a patient's body. The purpose of this study is to find out if patients with CLL/SLL make antibodies, or have an immune response, to the SARS-CoV-2 vaccines. Information gained from this study may help researchers better understand how effective the vaccines work in preventing COVID-19 (coronavirus disease 2019) in patients with CLL and SLL.

    at UC Irvine UCSD

  • Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

    open to eligible people ages 18-85

    Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.

    at UC Irvine

  • Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

    open to eligible people ages 18 years and up

    The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.

    at UCLA UCSF

  • KIDney Injury in Times of COVID-19 (KIDCOV)

    open to eligible people ages 18 years and up

    There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

    at UCSF

  • Long-term Impact of Infection With Novel Coronavirus (COVID-19)

    open to eligible people ages 18-100

    LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.

    at UCSF

  • Mushroom-based Product for COVID-19

    open to eligible people ages 18 years and up

    This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. The study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects.

    at UC Irvine UCLA UCSD

  • NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection

    open to eligible people ages 18-80

    This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.

    at UCLA

  • Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19

    open to eligible people ages 18 years and up

    COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care for respiratory support. Clinically, ARDS presents with severe hypoxemia evolving over several days to a week in combination with bilateral pulmonary infiltrates on chest X-ray. Widespread alveolar epithelial cell and pulmonary capillary endothelial injury can lead to severe impairment in gas exchange. In one report of 1,099 patients hospitalized with COVID-19, ARDS occurred in 15.6% of patients with severe pneumonia. In a smaller case series of 138 hospitalized patients, ARDS occurred in 19.6% of patients and in 61.1% of patients admitted to an intensive care unit (ICU). To date, no effective treatment has been established to treat COVID-19 or to prevent progression of ARDS. It is thought that a heightened immune response with an unbalanced release of inflammatory mediators in the airway is a major cause of morbidity and mortality associated with the disease. It is therefore reasonable to postulate that improved outcomes may be obtained in patients with a balanced immune response with adequate viral control and appropriate counter-regulatory immune responses whereas a poor outcome may be expected in patients with inadequate viral control or a heightened immune response or what is referred to as a "cytokine storm". Thus, modulating the pulmonary immune response without suppressing the immune system would be a viable strategy for patients with COVID-19. The current literature supports the role of neuromodulation, particularly vagal nerve stimulation (VNS), in modulating the immune response. Modulating the pro-inflammatory pathway through VNS has been demonstrated to decrease inflammatory mediators and improve outcomes in several animal models and in humans. Percutaneous electrical nerve field stimulation (PENFS) provides a novel, non-invasive method of VNS through a non-implantable device applied to the external ear. Already, the FDA has cleared this technology for reducing symptoms of opioid withdrawal in patients with opioid use disorder. Symptoms of opioid withdrawal can be decreased by approximately 90% after 1 hour of stimulation. Similarly, the IB-Stim device has been shown to improve symptom in children with abdominal-pain-related functional GI disorders and recently received market approval by the FDA for that indication. Unpublished studies have demonstrated marked decrease in inflammation with PENFS compared to sham stimulation in a model of TNBS colitis. While the efficacy of PENFS in modulating the progression of pulmonary disease in patients with COVID-19 is unknown, several proposed mechanisms for regulation of the immune response through VNS have already been demonstrated. We propose to perform an open label, randomized study to evaluate the efficacy of PENFS for the treatment of respiratory symptoms in patients with COVID-19.

    at UCLA

  • Outpatient Treatment of SARS-CoV-2 With Ivermectin, Fluvoxamine, and Metformin (COVID-19)

    open to eligible people ages 30-85

    The purpose of this trial is to conduct a Stage 1 Substudy powered to detect a difference in continuous laboratory outcomes: 1. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 infection can prevent hypoxia and emergency department utilization for Covid-19. 2. Test if metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxxamine vs metformin+ivermectin treatment in non-hospitalized adults with SARS-CoV-2 disease can prevent Covid-19 disease progression. 3. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 can improve viral load and CRP(self-collected, laboratory subsidy) 4. To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection. 5. To understand if any of the active treatment arms prevent long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection).

    at UCLA

  • Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

    open to eligible people ages up to 20 years

    The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

    at UCLA

  • Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

    open to all eligible people

    This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

    at UC Davis UCLA UCSD

  • Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California

    open to eligible people ages 18-99

    The United States (U.S.) is the country with the largest number of infections and deaths due to COVID- 19 and racial/ethnic minorities are disproportionately affected. Acceptance and uptake of COVID-19 vaccines will be instrumental to ending the pandemic. To this end, 2VIDA! (SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California) is a multilevel intervention to address individual, social, and contextual factors related to access to, and acceptance of, the COVID-19 vaccine by implementing and assessing a COVID-19 vaccination protocol among Latino and African American (AA) adults (>18 years old) in San Diego. 2VIDA! builds on our previous CBPR efforts and centers on conducting COVID-19 Individual awareness and education, linkages to medical and supportive services, and Community Outreach and Health Promotion in the intervention sites (Phase 1); and offering the COVID-19 vaccine to Latino and AA adults (>18 years old) in federally-qualified health centers and pop-up vaccination stations in communities highly impacted by the pandemic and identifying individual and structural barriers to COVID-19 immunization (Phase 2).

    at UCSD

  • Ramipril for the Treatment of COVID-19

    open to eligible people ages 18 years and up

    In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. After 14 days, patients will undergo a laboratory assessment and an end-of-treatment follow-up visit at day 28. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support.

    at UCSD

  • RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination

    open to eligible people ages 18 years and up

    This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

    at UCSD

  • Respiratory Virus Hospitalization Study (FLU 003 Plus)

    open to eligible people ages 18 years and up

    Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

    at UCSD

  • Role of Children in Transmission of COVID-19 to Immunocompromised Patients

    open to all eligible people

    This is a study of immunosuppressed individuals living in households with and without children to assess the role of household contact with children in the transmission of SARSCoV-2 to immunocompromised individuals. Through careful collection of epidemiological data in combination with biological specimens, risk factors for SARS-CoV-2 in immunocompromised individuals will be identified. During the initial visits, informed consent will be obtained and consented participants will complete an initial questionnaire and provide biological specimens including nasal swabs, saliva and blood. Thereafter, participants will complete at-home saliva collections and questionnaires on a weekly basis for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be referred immediately for medical attention and will be followed every 3 days with nasal swabs and saliva samples and weekly blood specimens and optional rectal swabs or fresh stool collection. Additionally, participants will be contacted by telephone at 1 year for follow-up.

    at UCLA

  • SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And • People who have never had COVID-19 (SARS-CoV-2 infection).

    at UCLA

  • Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19

    open to eligible people ages 18-80

    This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.

    at UCSF

  • Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation

    open to eligible people ages 18 years and up

    Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

    at UCLA

  • Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

    open to eligible people ages 18 years and up

    This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

    at UCLA

  • Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)

    open to eligible people ages 12 years and up

    The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

    at UCSF

  • Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants ≥16 Years of Age.

    open to eligible people ages 16 years and up

    The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization. The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19 - At a dose of 30µg (as studied in the Phase 2/3 study C4591001) - In healthy adults 16 years of age and older - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States, Brazil and South Africa

    at UC Davis

  • Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure

    open to eligible people ages 50 years and up

    The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.

    at UC Irvine

  • Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)

    open to eligible people ages up to 18 years

    The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.

    at UCLA

  • Tested Positive for COVID-19? Consider this clinical research trial testing a possible treatment option.

    open to eligible people ages 18 years and up

    This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

    at UC Davis

  • Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients

    open to eligible people ages 45 years and up

    The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

    at UC Irvine

  • The Provider Insurance Revenue Study in Healthcare Providers in the United States of America

    open to all eligible people

    The investigators are enrolling 100 healthcare Provider volunteers (n=100) from across the United States to help to evaluate and document the financial impact of COVID-19 on Physicians and other healthcare Providers. This investigation will compare individual Physician revenues before and after the advent of the COVID-19 pandemic. The investigators expect to be able to differentiate between revenues lost due to the COVID-19-driven business recession and revenues lost due to the manipulation of reimbursement processes by insurance companies. The inextricable linkage between Payer and Physician revenues suggests that Payer revenues are higher at the direct expense of Physicians, since both streams come from the same sources of funding. The secondary objective is aimed at revealing the methods Payers use to retain more money.

    at UC Irvine

  • The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)

    open to eligible people ages 18-75

    This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.

    at UCSD

  • The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

    open to eligible people ages 18 years and up

    Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

    at UCLA

  • Total-Body Parametric 18F-FDG PET of COVID-19

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    open to eligible people ages 18 years and up

    The primary objective is to measure the change between COVID-19 patients and normal subjects; the secondary objective is to measure the change in COVID-19 patients between baseline and 4-month follow up.

    at UC Davis

  • UNITE Study (UCSD-SW) for COVID-19

    open to eligible people ages 18 years and up

    The research objective of the UNITE Study is to assess the potential efficacy of ultrasound application to the spleen using a small wearable ultrasound system in the treatment of coronavirus disease 2019 (COVID-19) in a pilot study. Specific Aims: Determine the efficacy of splenic ultrasound in affecting markers of systemic inflammation in COVID-19 infection. Evaluate the potential efficacy of splenic ultrasound in affecting clinical outcomes in COVID-19 infection. Condition or disease: Covid19: Cytokine Storm Inflammation Device: Splenic Ultrasound Phase: Not Applicable

    at UCSD

  • A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19

    Sorry, accepting new patients by invitation only

    In this randomized double blind Phase 3 clinical trial we will study the efficacy and safety of oral polio vaccine with and without NA-831 versus placebo.

    at UCLA

  • A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

    Sorry, in progress, not accepting new patients

    The study will enroll 44,325 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

    at UCSD

  • A Study of Immune Responses to the Virus That Causes COVID-19

    Sorry, in progress, not accepting new patients

    The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

    at UCSF

  • A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

    Sorry, in progress, not accepting new patients

    The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

    at UCLA

  • A Study of the Experimental PET/CT Radiotracer "18F-avb6-Binding-Peptide" After COVID-19 (Coronavirus) Infection

    Sorry, accepting new patients by invitation only

    This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

    at UC Davis

  • A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

    Sorry, in progress, not accepting new patients

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.

    at UCLA UCSD

  • A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years) at Risk for SARS-CoV-2

    Sorry, in progress, not accepting new patients

    This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older with a pediatric expansion in adolescents (12 to < 18 years) in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections of either ARS-CoV-2 rS with Matrix-M1 adjuvant or placebo in the Initial Vaccination Period. Up to 33,000 participants will take part in the study. Following the recommendation of COVID-19 vaccination for all adults 18 years of age and older, adult participants will be scheduled for the administration of 2 injections of the alternate study material 21 days apart ("blinded crossover"). That is, initial recipients of placebo will receive SARS-CoV-2 rS with Matrix-M1 adjuvant and initial recipients of SARS-CoV-2 rS with Matrix-M1 adjuvant will receive placebo. A blinded crossover will be implemented for adolescents 12 to < 18 years of age approximately 6 months after the initial vaccination.

    at UC Davis

  • ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

    Sorry, not currently recruiting here

    This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

    at UCLA UCSF

  • ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19

    Sorry, not currently recruiting here

    This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-C stage will evaluate the combination of remdesivir with danicopan vs remdesivir with a placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of samples and may be conducted by phone. All subjects will undergo a series of efficacy and safety laboratory assessments. Safety laboratory tests and blood (serum, plasma and RNA) research samples on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. Blood research samples plus safety laboratory tests will be collected on Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if infection control considerations or other restrictions prevent the subject from returning to the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be obtained. The primary objective is to evaluate the clinical efficacy of danicopan relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

    at UCLA UCSF

  • Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

    Sorry, in progress, not accepting new patients

    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

    at UC Davis UC Irvine UCLA UCSF

  • An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

    Sorry, not accepting new patients

    This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study. A remote cardiac surveillance substudy will be optional for patients enrolled at the Mayo Clinic (select sites) and Memorial Sloan Kettering Cancer Center (MSKCC) sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

    at UCSF

  • Breastfeeding Education in the Time of COVID-19

    Sorry, in progress, not accepting new patients

    This project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.

    at UC Davis

  • Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

    Sorry, in progress, not accepting new patients

    The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.

    at UCLA UCSF

  • Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

    Sorry, in progress, not accepting new patients

    Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.

    at UCLA

  • Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

    Sorry, not currently recruiting here

    To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

    at UC Davis UC Irvine UCLA

  • Convalescent Plasma to Stem Coronavirus (CSSC-001)

    Sorry, in progress, not accepting new patients

    Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

    at UC Irvine UCLA UCSD

  • COVID-19 and Anti-CD14 Treatment Trial

    Sorry, not currently recruiting here

    This study aims to address the following objectives: 1. To determine the efficacy of IC14, an anti-CD14 chimeric monoclonal antibody, in patients hospitalized with respiratory disease and hypoxemia due to SARS-CoV-2, in terms of improving the time to resolution of disease. 2. To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2. 3. To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.

    at UCLA

  • COVID-19 and Venous Thromboembolism Risk

    Sorry, accepting new patients by invitation only

    Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.

    at UCSF

  • COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

    Sorry, not currently recruiting here

    This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different COVID-19 vaccine booster doses in participants with autoimmune disease requiring immunosuppressive medications. All study participants will have negative serologic or sub-optimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S (RBD) result ≤ 50 U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine. The study will initially focus on 5 autoimmune diseases: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus.

    at UCLA

  • Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

    Sorry, not yet accepting patients

    This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

    at UCLA

  • COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression

    Sorry, accepting new patients by invitation only

    This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.

    at UC Irvine

  • COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80

    Sorry, in progress, not accepting new patients

    A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis

    at UCLA UCSF

  • COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

    Sorry, accepting new patients by invitation only

    PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

    at UCLA UCSF

  • Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19

    Sorry, not yet accepting patients

    This is a multi-center, randomized, triple-blind, placebo-controlled (RCT) study to evaluate the efficacy and safety of Dapsone in older adults, and/or in adult patients (≥40yrs of age) with at least one high-risk comorbidity, among those with confirmed SARS-CoV-2 infection. 3000 infected patients diagnosed with COVID-19, non-hospitalized at the time of enrollment, meeting all inclusion and no exclusion criteria will be randomized (1:1 allocation ratio) to receive either Dapsone or placebo tablets for 21 days, and will be followed up for 7 days after treatment termination for outcome assessment and up to 30 days for safety monitoring.

    at UCLA

  • Developing and Testing a COVID-19 Vaccination Acceptance Intervention

    Sorry, not yet accepting patients

    The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation.

    at UCSF

  • Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19

    Sorry, in progress, not accepting new patients

    This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

    at UC Davis UC Irvine

  • Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

    Sorry, in progress, not accepting new patients

    This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

    at UC Irvine

  • Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

    Sorry, not accepting new patients

    The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

    at UCSF

  • Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination

    Sorry, not yet accepting patients

    This study develops and evaluates the "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus Short Message Service (SMS) text messaging to SMS text with LHW support.

    at UC Davis UCSF

  • Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

    Sorry, accepting new patients by invitation only

    The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.

    at UCSD

  • Harnessing Online Peer Education Online Support Intervention for COVID-19 (HOPE COVID-19)

    Sorry, not yet accepting patients

    The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19.

    at UC Irvine

  • Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

    Sorry, not yet accepting patients

    This is a pilot study in 24 subjects where half will be randomized to 10 treatments with hyperbaric oxygen (HBO). It will primarily study pulmonary sequelae with imaging and physiological measurements (low dose chest computer tomography (CT), Ventilation/perfusion with magnetic resonance imaging (VA/Q MRI), cardiopulmonary exercise testing with pulse oximetry (SpO2) and spirometry including diffusion capacity for carbon monoxide (DLCO). The target patient group will be previously healthy whom have had covid-19 with lingering symptoms past 12 weeks of recovery from the acute phase.

    at UCSD

  • Immunophenotyping Assessment in a COVID-19 Cohort

    Sorry, in progress, not accepting new patients

    This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.

    at UCLA UCSF

  • LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

    Sorry, in progress, not accepting new patients

    To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

    at UCSD

  • Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19

    Sorry, in progress, not accepting new patients

    This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

    at UC Davis UC Irvine

  • Pediatric Acute Kidney Injury in COVID-19

    Sorry, accepting new patients by invitation only

    This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.

    at UCLA

  • Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.

    at UC Irvine

  • Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

    Sorry, in progress, not accepting new patients

    The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

    at UCLA

  • Pilot Evaluation of Together for Wellness Website in COVID-19

    Sorry, not yet accepting patients

    This is a pilot evaluation of a set of free digital mental health resources developed for COVID-19 relief in California, with funding for the evaluation by the California Health Care Foundation. The website includes resources to support information on COVID-19, meditation and stress management, resources for parenting resilience, resources for social connection and addressing structural racism, and linkages to resources under the partnering "CalHOPE" website (FEMA funded). The evaluation includes: 1) an invitation from a partnering agency to visit the website and consider the evaluation; 2) a post website visit baseline survey; 3) a follow-up survey 4-6 weeks later; 4) a telephone interview for a subset of participants who agree to the follow-up interview and provide their contact information.

    at UC Davis UCLA

  • PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

    Sorry, not currently recruiting here

    The purpose of this study is to describe the pharmacokinetic (PK) properties and safety of remdesivir (GS-5734TM) (RDV) administered to pregnant and non-pregnant women with COVID-19. It is a Phase I, prospective, open label, non-randomized opportunistic PK study in pregnant and non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. RDV will not be provided as part of the study.

    at UCLA UCSD

  • Predicting Outcomes for Covid-19 Using Sonography

    Sorry, accepting new patients by invitation only

    This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.

    at UCSF

  • Study of Descartes-30 in Acute Respiratory Distress Syndrome

    Sorry, not currently recruiting here

    Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19

    at UC Irvine

  • Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

    Sorry, not yet accepting patients

    This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.

    at UCSF

  • Study of monoclonal antibodies for household members of patients with COVID-19

    “We're looking for household contacts of someone with COVID-19 to see if a new medicine may prevent infection or reduce severity of COVID-19”

    Sorry, in progress, not accepting new patients

    Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

    at UCLA

  • Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

    Sorry, not currently recruiting here

    This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - As a booster; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.

    at UC Davis

  • Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

    Sorry, in progress, not accepting new patients

    This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

    at UCLA

  • Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

    Sorry, in progress, not accepting new patients

    The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

    at UCLA

  • Text-based Interventions to Promote COVID-19 Vaccinations

    Sorry, accepting new patients by invitation only

    This study investigates whether and which type of text-based interventions affect the take-up of the COVID-19 vaccine.

    at UCLA

  • Text-based Reminders to Promote COVID-19 Vaccinations

    Sorry, accepting new patients by invitation only

    This study investigates whether and which type of text-based reminders affect the take-up of the COVID-19 vaccine.

    at UCLA

  • Understanding Community Considerations, Opinions, Values, Impacts, and Decisions for COVID-19

    Sorry, in progress, not accepting new patients

    The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.

    at UCLA

  • ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)

    Sorry, not accepting new patients

    Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization. Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download

    at UC Irvine

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