This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.
The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
Study type: Interventional (Clinical Trial)
Estimated Enrollment: 630 participants
Official Title: Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial
Actual Study Start Date: April 16, 2020
Estimated Study Completion Date: October 2020
At increased risk of developing severe COVID-19 disease (at least one of the following)
* Additional criteria apply. Please speak with the study team for further information.
Placebo Comparator: Ascorbic acid and Folic acid
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Experimental: Hydroxychloroquine and Folic Acid
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days [Days 2 to 5])
Experimental: Hydroxychloroquine and Azithromycin
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Thank you for your interest in advancing COVID-19 treatments.
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For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you’ll be connected to the study team.