Study Description

COVID-19 is a new illness caused by the severe acute respiratory syndrome coronavirus (SARS CoV-2). There is currently no vaccine to prevent SARS-CoV-2 infection, or medicine proven to treat COVID-19. Therefore, there is an urgent public health need for rapid development of new therapies. A5395 is a clinical trial designed to compare the efficacy of hydroxychloroquine (HCQ) plus azithromycin (Azithro) versus placebo in symptomatic adult outpatients with COVID-19.

Why is this study being done?

  • To see if hydroxychloroquine (HCQ) and azithromycin (Azithro) treatment will prevent hospitalizations and death in adults with COVID-19.

Who can join?

Persons who:

  • Are 18 years of age or older
  • Have a positive test for COVID-19 from a nose or throat specimen collected within 96 hours prior to when the first dose of study treatment is expected to be taken
  • Are experiencing at least one of the following symptoms within 24 hours: fever, cough, or shortness of breath
  • Have no need for hospitalization
  • Agree not to participate in another COVID-19 study, unless if hospitalized

What do I need to do in the study?

The study is designed to minimize in-person contact between participants and study staff. The informed consent process, screening, study entry, and follow-up may be performed remotely or in person.

At study entry, participants will have an in-person or remote (for example, video) study visit, and will receive a study kit (which will include enough pills for the whole course of study treatment) and a diary in which to record symptoms and when study medications are taken. Participants will provide medical and medication histories, contact information, complete the first day of their symptom and medication diary, and take their first dose of study treatment.

Study staff will contact participants by phone on Days 2, 4, 6, 9, 13, and 17, and at 3 and 6 months after they enter the study. At each visit, participants will be asked how they have been feeling healthwise, review their symptoms and treatment, and record any hospitalizations or urgent visits to emergency rooms or clinics. Participants will return their symptom diary by mail or in person on Day 20. At select sites, participants will have the option of having a blood draw, a nose-throat swab, and a self-collected nose swab at study entry and on Days 6 and 20 (in-person visits).

What treatments or drugs are involved with this study?

Participants will have a 50/50 chance of receiving either active or placebo study treatment, as follows:

  • Hydroxychloroquine/Placebo two (200 mg each) capsules by mouth twice on the first day, and then one (200 mg) capsule twice a day for 6 days

and

  • Azithromycin/Placebo two (250 mg each) capsules by mouth once on the first day, and then one (250 mg) capsule every day for 4 days.

Treatment will be for 7 days, with 23 weeks of follow-up.

 

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