Treatment for SARS-CoV-2 in High-Risk Adult Outpatients
Clara Health

Treatment for SARS-CoV-2 in High-Risk Adult Outpatients

Sponsored by University of Washington


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.

About 
COVID-19

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.

How is this study designed?

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

Who is this study for?

Inclusion Criteria*:

  • Men or women 18 to 80 years of age, inclusive, at the time of signing the informed consent
  • Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
  • Access to device and internet for Telehealth visits
  • At increased risk of developing severe COVID-19 disease (at least one of the following)

  • Age ≥60 years
  • Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema
  • Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
  • Hypertension, requiring at least 1 oral medication for treatment
  • Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)
  • Immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies)
  • Body mass index ≥30 (self-reported)

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

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).

Connect with the study team

Thank you for your interest in advancing COVID-19 treatments.

Please fill out this contact form to be connected to a member of the study team. The following information that you enter will only be authorized to be shared with the research team conducting this specific study.

If you have any difficulties or questions, please contact our support specialists at [email protected]

Have a question?

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.