PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
Clara Health

PATCH 2&3: Prevention & Treatment of COVID-19 With Hydroxychloroquine

Sponsored by UnitedHealth Group


The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection.

This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.

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: 850 participants Official Title: PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) An Open Label Multi-arm Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19 Actual Study Start Date: April 7, 2020 Estimated Study Completion Date: June 15, 2021

Who is this study for?

Sub-Study 1: 50-75 years of age; self-reporting as having a fever within four days prior to time of enrollment; and not requiring hospitalization. Enrolled individuals will undergo testing for COVID-19 and sent home for self-quarantine. Participant must be willing and able to provide informed consent, agree to testing for COVID-19 at time of enrollment to confirm diagnosis and two weeks at the end of treatment.

Sub-Study 2: Currently employed as a health care worker. Health care workers meeting the following criteria:

  • asymptomatic and presumed negative for COVID-19 (no confirmatory testing conducted);
  • scheduled for an average of >20 hours per week of clinical care over the next 2 months.

What should I expect?

Sub-Study 1: COVID-19 patients in self-quarantine.

  • Arm 1: Hydroxychloroquine 400 mg bid (two 200 mg tablets taken twice a day; totaling 800 mg per day) for two weeks;
  • Arm 2: Placebo 2 pills twice a day for two weeks

Sub-Study 2: Asymptomatic health care worker prophylaxis.

  • Arm 1: Hydroxychloroquine 600 mg once a day (three 200 mg tablets taken once a day) for up to 2 months;
  • Arm 2: Placebo 3 pills once a day for up to 2 months; cross-over from placebo to HCQ 600 mg once a day is allowed upon confirmatory diagnosis for COVID-19.

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.