Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

Details

This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The protocol is for a randomized, blinded, controlled platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. This platform study involves 2 stages. In stage 1, safety will be evaluated and two intermediate outcomes will be assessed to determine whether a drug advances to stage 2. Treatments considered to have demonstrated unacceptable risks relative to benefits, or those which do not reach the effectiveness threshold for the stage 1 intermediate outcomes, will not advance to stage 2. In some cases, stage 1 may include 2 or 3 doses of the same investigational drug, which will be considered separate drugs for the purpose of the study. Investigational drugs with reasonably well-established safety profiles and evidence of effectiveness (i.e. at least equivalent to the criteria for advancement of a drug from stage 1 to stage 2) may enter the study directly at stage 2. Conversely, for drugs with minimal pre-existing safety evidence, the pace of stage 1 will initially be restricted and there will be an early review of safety data by an independent Data and Safety Monitoring Board (DSMB). A Phase 1 dose escalation study for some investigational drugs may be required, and if so, the Phase 1 study would precede stage 1 and be carried out as a separate protocol. The international trials within this protocol will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

Keywords

Covid19 COVID-19 COVID 19 Coronaviridae Infections Coronavirus Infections RNA Virus Infections Virus Diseases Nidovirales Infections SARS-CoV-2 SARS Coronavirus ACTIV-3 ACTIV3 Remdesivir

Eligibility

You can join if…

Open to people ages 18 years and up

  • Signed informed consent.
  • Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
  • Symptoms of COVID-19 for ≤ 12 days.
  • Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).

You CAN'T join if...

  • Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
  • Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study.
  • Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
  • Patients considered unable to participate in study procedures.
  • Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to abstain from sexual intercourse with men, or practice appropriate contraception through Day 90 of the study.
  • Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Day 90 of the study.
  • [Stage 1 only] Presence at study enrollment of any of the following:
  • stroke
  • meningitis
  • encephalitis
  • myelitis
  • myocardial ischemia
  • myocarditis
  • pericarditis
  • symptomatic congestive heart failure
  • arterial or deep venous thrombosis or pulmonary embolism
  • [Stage 1 only] Current or imminent requirement for any of the following:
  • invasive mechanical ventilation
  • ECMO (extracorporeal membrane oxygenation)
  • Mechanical circulatory support
  • vasopressor therapy
  • commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Locations

  • Community Regional Medical Center (Site 203-005), 2823 Fresno Street
    Fresno California 93701 United States
  • Mount Zion Hospital, UCSF Medical Center (Site 203-007), 1600 Divisadero St.
    San Francisco California 94115 United States
  • Moffitt-Long Hospital, UCSF Medical Center (Site 203-001), 505 Parnassus Ave.
    San Francisco California 94143 United States
  • San Francisco VA Healthcare System (Site 074-002), 4150 Clement St.
    San Francisco California 94121 United States
  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
FDA Safety Alerts and Recalls CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website A Participant's Guide to Clinical Trials (NIAID) Find a Clinical Trial (NIAID) Clinical Trials at NIAID National Institute for Allergy and Infectious Diseases (NIAID) NIH COVID-19 treatment guidelines WHO COVID-19 treatment guidelines
ID
NCT04501978
Phase
Phase 3
Study Type
Interventional
Last Updated