High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
Clara Health

High-dose Hydroxychloroquine for Patients With Mild COVID-19

Sponsored by University of Chicago


This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.

In vitro studies have shown antiviral effects of HCQ against SARS Cov-2, but the clinical outcomes in the disease have been variable. Our hypothesis is that targeting high risk patients earlier in the disease course and with a higher dose regimen are both required to see improvement in disease outcome measures in COVID-19. This study aims to prove the tolerability of high dose HCQ in this setting.

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: 20 participants Estimated Study Start Date: April 2020 Estimated Study Completion Date: June 2020

Who is this study for?

Inclusion Criteria*:

  • Being tested positive for SARS-Cov-2 in outpatient setting in drive-thru, ED, or ambulatory clinics at the University of Chicago within 72 hours of enrollment.
  • Age >18
  • Fever >100.4 F by any conventional clinical method (forehead, tympanic, oral, axillary, rectal) within 48h prior to enrollment
  • Mild COVID-19, defined as the presence of any symptom consistent with an upper respiratory tract infection, including dry cough, sore throat, nasal congestion, fatigue, myalgia, headaches.

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

What should I expect?

  • Patients are selected based on the identification of risk factors associated with more severe disease outcomes.
  • Investigators will enroll twenty patients and perform a detailed Tele-health interview to ensure they meet eligibility criteria and provide informed consent.
  • 1200 mg hydroxychloroquine daily will be prescribed, in divided doses.
  • The subjects will be required to monitor their temperatures twice daily and a daily telephone call with an investigatory will review symptoms of disease and potential side effects of the drug.
  • Subjects can discontinue the medication after five days if they no longer have fever, or take the medication for up to ten days if required for fever resolution.

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.