Summary

Eligibility
for people ages 18-84 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

Official Title

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease

Details

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), is an enveloped, positive-sense, single-stranded ribonucleic acid (RNA) betacoronavirus. Symptoms of COVID-19 infection may appear from 2 to 14 days following exposure, with the spectrum of illnesses ranging from mild symptoms to severe illness or death. The identification of SARS-CoV-2 follows the emergence of 2 other novel betacoronaviruses: SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV). Current management of COVID-19 is supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. While an understanding of the epidemiology and clinical spectrum of COVID-19 is still evolving during the ongoing pandemic, the current knowledge of the disease burden highlights the urgent medical need to develop a treatment. Sirukumab (also known as CNTO136) is a human anti-interleukin (IL)-6 immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb). Sirukumab binds with high affinity and specificity to human IL-6 and as a result inhibits IL-6-mediated signaling and the biological effects of IL-6. The study will include a Screening Phase (up to 1 Day), a Treatment Phase (Day 1 to Day 28) and a Follow-up Phase (post Day 28, follow-up phone calls on Week 8, Week 12 and Week 16). Safety evaluations will include monitoring of adverse events and serious adverse events, physical examinations, vital sign measurements, electrocardiograms, clinical laboratory tests, pregnancy testing, and checking of vital status. The entire study duration for each participant will be 16 weeks.

Keywords

Severe or Critical Confirmed Coronavirus Disease (COVID)-19 Coronavirus Infections Sirukumab

Eligibility

You can join if…

Open to people ages 18-84

  • Hospitalized
  • Has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by real time-polymerase chain reaction (PCR) at any time before randomization
  • Evidence of infiltrates by chest X-ray, chest computed tomography (CT), lung ultrasound, or chest auscultation (rales, crackles)
  • Informed consent must be obtained from the participant indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • SEVERE OR CRITICAL COVID-19 DISEASE: Severe disease: requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device. Critical disease: Requires supplemental oxygen delivered by nonrebreather mask or high-flow nasal cannula or use of non-invasive or invasive ventilation or requiring treatment in an intensive care unit.

AND at least one of the following: Not receiving supplemental oxygen and having a peripheral capillary oxygen saturation (SpO2) of <=93% sustained for 5 minutes (corresponds to category 3 on the 6-point ordinal scale) OR receiving supplemental oxygen to sustain a peripheral capillary oxygen saturation (SpO2) greater than (>) 93 percent (%) regardless of device/route used, OR partial pressure of oxygen in arterial per percentage of inspired oxygen (PaO2/FiO2) ratio < 300 millimeter of mercury (mmHg) while on invasive mechanical ventilation or veno-venous ECMO for less than 48 hours prior to screening) (corresponds to category 5 on the 6-point ordinal scale)

You CAN'T join if...

  • On invasive mechanical ventilation or on veno-venous ECMO for >48 hours at time of screening
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned dose of study intervention. Note: the investigator must ensure that the participant is not enrolled in another COVID-19 study with an investigational intervention (apart from the exception specified below) prior to completion of Day 28 of the current study.

Exception: participation in a single arm study, a non-blinded controlled study, expanded access, compassionate use program or any other program that is not a blinded study is allowed if it is conducted with one of the following: agents with demonstrated in vitro-effect against SARSCoV- 2, as mentioned in the center of disease control and prevention (CDC) guidelines and convalescent plasma

  • Current confirmed or high suspicion for pulmonary embolus, hemodynamic significant pericardial effusion, myocarditis, or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification AND/OR Current evidence of active cardiac ischemia
  • Has a history of respiratory condition (that is, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, fibrotic lung disease) that requires home oxygen supplementation, supportive non-invasive ventilation or, is status/post lung volume reduction surgery (LVRS). Exception: Participants with sleep apnea using supportive non-invasive ventilation (continuous positive airway pressure [CPAP]) at screening may be included
  • On renal replacement therapy (defined as peritoneal dialysis or hemodialysis)
  • Screening laboratory test result as follows: absolute neutrophil count (ANC) <1.0103 cells/microliter; Platelet count <50103 cells/microliter; estimated glomerular filtration rate (eGFR) <=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m2); Bilirubin >2 upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; alanine aminotransferase/ aspartate aminotransferase (ALT) >5ULN; Prothrombin time (PT)/international normalized ratio (INR) >1.5ULN or activated partial thromboplastin time (aPTT) >1.5ULN related to known coagulopathy or bleeding disorder (the participant can receive anticoagulant therapies for underlying conditions, or as systematic thromboprophylaxis due to COVID-19, or as part of the treatment of complications of COVID-19, but cannot participate in a clinical study with anticoagulants for COVID-19)

  • Pregnant or breastfeeding, unless in the opinion of the investigator, the benefit outweighs the risks
  • Has active hepatitis B or C infection or human immunodeficiency virus infection or acquired immune deficiency syndrome (HIV/AIDS) based on medical history and/or concomitant medication
  • Known active or latent tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB based on medical history and/or concomitant medication
  • Evidence of active bacterial (including but not limited to bacterial pneumonia), fungal, viral or opportunistic infection (other than SARS-CoV-2)
  • Currently active clinically significant (example, causing hemodynamic instability and/or causing hypoxemia) and uncontrolled arrhythmia

Locations

  • UCSF Fresno not yet accepting patients
    Fresno California 93701 United States
  • Hoag Memorial Hospital accepting new patients
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Pharmaceutica N.V., Belgium
Links
To learn how to participate in this trial please click here.
ID
NCT04380961
Phase
Phase 2
Study Type
Interventional
Last Updated