Therapeutic Protocols for Ambulatory Patients


Study & PI
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
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.
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection: The PROTECT Study

PI: Mark Sulkowski
The PROTECT study is a prospective, randomized, blinded, controlled trial of two weekly subcutaneous injections of lambda interferon alpha-1a versus placebo. Study subjects are the non-hospitalized household contacts of individuals with confirmed COVID-19 infection who can be either negative (Prevention cohort) or positive (Treatment cohort) for SARS-CoV-2 at the time of study entry. All participants will be followed for an observation period of up to 10 weeks.
A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons with COVID-19

PI: Kelly Dooley
Adults with COVID-19 in the outpatient setting will be randomized 1:1 to receive hydroxychloroquine or placebo for 7 days; and azithromycin or placebo for 5 days. Randomization will be stratified by “high” versus “low” risk of severe disease, where “high” risk is defined as a person age ≥60 years or having at least one of several specified comorbidities. Secondary objectives include determining the frequencies of all adverse events; as well as any decrease in the levels of detectable SARS-CoV-2 RNA.