15 May COVID-19 OUTPATIENT TREATMENT STUDY
Effective therapies for COVID-19 are urgently needed.
There has yet to be a well-designed, fully-powered, placebo-controlled trial to determine the potential efficacy of these drugs in any stage of COVID-19, yet alone to stop the progression of disease.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating medications for the study.
Main Purpose of this Investigational Study:
This study will see if low-dose hydroxychloroquine (HCQ) and azithromycin (Azithro) treatment will prevent hospitalizations and death in adults with COVID-19.
Length of Study:
(including 7 days of treatment, 23 weeks of follow-up)
Overview of Study:
Most participants will have visits by phone or telemedicine.
Participants will have a 50/50 chance (like flipping a coin) of receiving the active treatment or placebos. Neither the study staff nor the participants will know which arm they are in.
There will be 10-11 visits total.
During the first few days of the study you will be taking study medication. Neither the study staff nor you will know whether you have been randomly assigned to receive study drugs of Hydroxychloroquine (HCQ) and Azithromycin (Azithro) or look-alike placebos. You will take:
HCQ (or placebo) as 2 pills twice per day for one day, then 1 pill twice per day for 6 more days (with food or glass of milk)
Azithro (or placebo) as 2 pills on first day and 1 pill on the next 4 days
You will be contacted by the study site on a regular basis during the first three weeks and then again after 3 and 6 months.
After 3 weeks you will return your symptom/medication diary to the study site, either in person or as instructed by the study site.
We ask that you contact the study site if at any time during the study you get hospitalized.
A small number of people enrolled in the study will have blood drawn and nasal swabs performed at their study site on the first day of study, after 1 week of study and then nasal swabs obtained at the week 3 visit.
If you are in this group, the study staff will arrange these in-person visits with you.
HCQ or Placebo 400 mg (two 200 mg capsules) by mouth twice at least 8 hours apart starting on the first day, followed by 200 mg (one capsule) twice a day for 6 days. Hydroxychloroquine/Placebo should be taken with food or milk
Azithro or Placebo two (250 mg each) capsules by mouth once on the first day and then one capsule (250 mg) every day for 4 additional days.
The medications can be taken together.
Visits by telephone or telemedicine, medical history, study diary (symptoms and
medicine-taking), information about any subsequent hospitalization, provide emergency contact information.
$50 after the study diary has been returned on or after day 20.
A subset of participants will be asked to have 3 of the visits in-person and have blood draws, a self-collected nose swab, and a staff-collected deep nose swab. Additional reimbursement will be provided for these procedures ($90 total).
Contact: ACTU Staff 206-773-7129 (text or call)
Main Requirements to Enter This Study:
– 18 years of age or older
– Positive test of the nose or throat for COVID-19 RNA from any respiratory specimen (collected within 96 hours prior to when the first dose of study treatment is expected to be taken)
– Experiencing at least one of the following symptoms: fever, cough, or shortness of breath
– Agreement to not participate in another COVID-19 study during the study period or take HCQ or Azithro from a source outside of the study. (If a participant is hospitalized during the study, they can participate in another COVID-19 study.)
Additional Study Details
Full Study Title
A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons with COVID-19 (Haz-COVID)
Ann C. Collier
Accepts Healthy Volunteers?
Harborview Medical Center
325 9th Avenue 2 West Clinic Desk B
Seattle, Washington 98109