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

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

The purpose of this study is to assess the effectiveness of hydroxychloroquine (HCQ) or HCQ/azithromycin for the treatment of SARS-CoV-2 infection (the virus that causes COVID-19) in those adults who have been diagnosed with the virus. We plan on enrolling 635 participants from sites all over the country.

Eligible participants will be randomly assigned to receive either HCQ and folic acid, HCQ and azithromycin, or ascorbic acid (Vitamin C) and folic acid for 10 days. All participants in one household will receive the same intervention. Study will last 28 days and will include no in-person visits. All contact will be completed through HIPAA compliant video-conference (telehealth).

Participants will be asked to collect daily mid-nasal swabs, complete a twice daily survey, collected vitals twice a day, and take their assigned medicals twice a day. Participants will receive a schedule outlining the activities. Most activities will take place during the first 14 days of the study. After enrollment, there will be 4 follow-up visits. All will be via Telehealth or phone. At various timepoints during the study, swab pick-up will be arranged via courier. Participants will be offered participation into an optional sub-study that involves the collection of a dried blood samples.

Participants will be compensated $200 for the 28-day study.

Participant Eligibility

– 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

Contact

UW COVID-19 Treatment team
(206) 520-4366

Additional Study Details

Full Study Title
Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

Study ID: 1282184
Start Date: 04/15/2020
End Date: 04/03/2021

Investigator(s)
Dr. Christine Johnston, University of Washington

Accepts Healthy Volunteers?
No

Study Site(s)

University of Washington

908 Jefferson Street 11NJ1166
Seattle, Washington 98104



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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