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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
AIDS Clinical Trials Group AstraZeneca Brii Biosciences Limited Bristol-Myers Squibb Eli Lilly and Company SAb Biotherapeutics, Inc. Sagent Pharmaceuticals Synairgen Research Ltd.