Clinical Trial TitleAdaptive platform treatment trial for outpatients with COVID-19.
National Clinical Trial Number:NCT04518410
Clinical Trial Protocol Description:
Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.
The trial is a randomized, blinded, controlled adaptive platform that allows agents to be added and dropped during the course of the study for efficient testing of new agents against placebo within the same trial infrastructure. When two or more new agents are being tested concurrently, the same placebo will be used, if feasible.
The primary outcome measures in the phase II evaluation will be duration of symptoms, similar to the outcome used for outpatient influenza studies, loss of detection of SARS-CoV-2 RNA by nasopharyngeal (NP) swab, and safety. Determination of whether a phase II agent will continue to be evaluated in phase III will be made after the last participant randomized to that agent or placebo group completes their day 28 phase II visit. If continued, data collected from participants enrolled in phase II will be included in the phase III evaluation.
The phase III evaluation is a continuation of the phase II trial for agents that meet study-defined criteria for further evaluation and for which sufficient investigational agent is available. An agent may also enter directly into phase III evaluation based on Trial Oversight Committee (TOC) assessments. The fully powered phase III trial will evaluate the efficacy of each selected investigational agent compared to placebo to prevent hospitalization and death in non-hospitalized adults with COVID-19.
The protocol will be amended when information becomes available from within or outside of the trial indicating that further randomization to a placebo is inappropriate.
As of 10/20/20 the only investigational agent being administered through the trial is LY3819253 a monoclonal antibody directed against the spike protein of SARS-CoV-2. This monoclonal antibody blocks the attachment of the spike protein to human angiotensin-converting enzyme 2 (ACE2) receptors preventing entry of the virus into human cells. Participants receive a single 1 hour infusion versus a placebo saline infusion. Participants are randomized 1 to 1 to receive active drug versus placebo.
Participants have on-site visits on Day. 0, 3, 7, 14, 21, 28, week 12, and week 24. There are daily phone calls over the first 28 days. There is monetary reimbursement for your time.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older
- Have documented SARS-CoV-2 infection from any nasal/respiratory swab collect ≤ 168 hours prior to study entry.
- Have no more than 10 days of symptoms at study entry.
- Have an oxygen saturation of ≥92% within 48 hours of study entry and have one or more symptoms of COVID-19 infection within 48 hours of study entry.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.