Hydroxychloroquine in Outpatient Adults With COVID-19
Clara Health

Hydroxychloroquine in Outpatient Adults With COVID-19

Sponsored by Sanofi


Primary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives: To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19.

To assess the safety and tolerability of hydroxychloroquine in outpatient adults with 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: 210 participants Primary Purpose: Treatment Actual Study Start Date: March 31, 2020 Estimated Study Completion Date: May 2020

Who is this study for?

Inclusion criteria :

  • Participants with diagnosis of COVID-19 via nasopharyngeal swab Polymerase Chain Reaction (PCR)
  • Time between onset of symptoms and enrollment is 72 hours or less

Exclusion criteria:

  • Severe COVID-19 requiring inpatient treatment
  • Women who are pregnant or breastfeeding
  • Concurrent antimicrobial therapy
  • History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis
  • History of retinopathy
  • History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death
  • History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

What should I expect?

The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)

Inpatient trial premium listing (no trial site names)

Have questions or need help?

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 team.