ACTIV-2: A Study for Outpatients With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronavirus
- COVID-19
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 study includes both infused and non-infused agents. Ver...
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 study includes both infused and non-infused agents. Version 6.0 of the protocol restricts enrollment to agents in phase II to participants at lower risk of progression to severe COVID-19, regardless of the mode of administration of the agent. The current phase III evaluation will continue as a placebo-controlled evaluation of the one agent that has previously been approved for full phase III evaluation by the Trial Oversight Committee (TOC) and will continue to include only participants who are at higher risk of progression to severe COVID-19. The design of the phase III evaluation for future agents will be developed in a subsequent version of the protocol and will include an active-controlled comparator instead of a placebo control. Investigational agents will be selected by the TOC for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability.
Tracking Information
- NCT #
- NCT04518410
- Collaborators
- Eli Lilly and Company
- AIDS Clinical Trials Group
- Brii Biosciences Limited
- AstraZeneca
- Sagent Pharmaceuticals
- Synairgen Research Ltd.
- Bristol-Myers Squibb
- SAb Biotherapeutics, Inc.
- Investigators
- Study Chair: David Smith, MD, MAS University of California, San Diego
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