Therapeutic Protocols for Ambulatory Patients

 

Study & PI
Summary
Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune) Plasma Among Outpatients with Symptomatic COVID-19

PI: David Sullivan
Enroll:  888-506-1199 or visit www.covidplasmatrial.org 

This study will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) to reduce the risk of hospitalization or death in adults who are positive by RNA detection for SARS-CoV-2 and have at least one symptom of COVID-19. In addition, the impact of HCIP on the duration of symptoms and nasopharyngeal or oropharyngeal viral shedding will be assessed. Eligible subjects will be stratified 50:50 in the <65 vs > 65 age range and will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
A 5401/ACTIV-2: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID), version 1.0, dated 07/07/2020

PI: Kelly Dooley
This 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 multicenter, 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. At least 50% of participants will meet the protocol definition of being at “high” risk of progression to severe COVID-19. Randomization in both phase II and phase III will be stratified by 1) time from symptom onset and 2) “high” versus “low” risk of progression to severe COVID-19.