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.
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.

A novel pneumonia caused by a previously unknown betacoronavirus emerged in Wuhan, China, in December 2019. The virus is closely related to severe acute respiratory syndrome coronavirus- 1 (SARS-CoV-1), which caused an outbreak in 2003, and has been named SARS-CoV-2. The human disease caused by SARS-CoV-2 is called Coronavirus disease 2019 (COVID-19). During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on 16 February 2021, there were 108,822,960confirmed cases of COVID-19, globally including 2,403,641 deaths, and in Kenya, 103,014 confirmed cases including 1,795 deaths as reported by World Health Organization (WHO). Despite quarantine measures, and all infection prevention measures, SARS-CoV-2 has spread globally, infecting millions worldwide and killing hundreds of thousands. Global efforts to evaluate novel antivirals and therapeutic interventions to treat COVID-19 have intensified. There is currently no vaccine to prevent SARS-CoV-2 infection nor any therapeutic agent to treat COVID-19. Therefore, there is an urgent public health need for rapid development of novel interventions. This 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. The study will evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. The current investigational agents that is being evaluated in Kericho are monoclonal antibodies BRII-196 and BRII-198 administered intravenously, and AZD7442 administered intravenously. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents. In phase II, an investigational agent will be evaluated for safety, as well as for activity in reducing the duration of COVID-19 symptoms over 28 days, and frequency of loss of detection of SARS-CoV-2 RNA in Nasopharyngeal (NP) swabs as compared to control. In phase III evaluation, which is a continuation of the phase II trial for agents that meet study-defined criteria for further evaluation, the study 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 study will enroll outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤10 days prior to study entry and with ≤8 days of symptoms of COVID-19 at study entry, plus the presence of select symptoms within 24 hours prior to study entry. The Kericho site will enroll a total of up to 50 participants per investigational agent. The participants will be followed up for 24 weeks or up to 72weeks after enrollment depending on the investigational agent. The study will provide information on therapies to be used in outpatient setting, to prevent disease progression, and reduce serious complications of COVID-19 and transmission.