Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II(4.4 mi away)Contact
+238 other location
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. Participants in the study will be treated with either a study drug or with
placebo and will have 28 days of intensive follow-up following study drug administration,
followed by limited follow-up through 24 weeks. Study visits may be required after week 24
depending on the study agent.
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
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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