UW ACTU seeks 2,000 patients for potential new COVID-19 treatment

A study is now enrolling participants to determine whether a treatment combining a low dose of hydroxychloroquine and azithromycin can prevent hospitalization and death in people with COVID-19.

Dr. Ann Collier, professor of medicine, Division of Allergy and Infectious Diseases at the University of Washington School of Medicine, explains the national study is looking to enroll 2,000 patients at sites across the country. This research project is separate from another hydroxychloroquine clinical study at UW Medicine, but the results will complement each other.

To enroll, call or text 206-773-7129 or email actu@uw.edu.

WHO: People aged 18 and up with symptoms of fever, cough, or shortness of breath and confirmed active COVID-19 as determined by an FDA approved RNA test less than 96 hours before entering the study who do not need to be hospitalized.

WHY: To see if the investigational use of low dose Hydrochloroquine (HCQ) & Azithromycin (AZITHRO) will prevent hospitalization and death in people with symptomatic COVID-19.

WHAT: Participants will be randomized (like flipping a coin) to one of two groups:

Arm A: HCQ (orally twice a day for 7 days) and Azithro (2 capsules orally on the first day; then one capsule daily for four additional days).

Arm B: Placebo for HCQ (orally twice a day for 7 days) and placebo for Azithro (2 capsules orally on the first day, then one capsule daily for four additional days).

HOW LONG: Treatment will be for 7 days with 23 weeks of follow-up.

HOW: Giving a medical history; keeping a study diary to record symptoms and adherence to the treatment regimen; and completing 11 telephone visits. ($50 compensation at day 20.)

A subset of participants who agree will undergo self-collected nasal swabs, staff-collected nasal swabs, and blood draws. (Up to $50 more compensation.)

HOW DOES IT WORK?
Study Treatment
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) AND Azithro (or placebo) as 2 pills on first day and 1 pill on the next 4 days

Study Activities
Included in this Study Kit are:

o Contact numbers for study site members and information on who to contact if you are feeling worse.

o A diary to write down your symptoms, temperature (if you have access to thermometer), any medications you are taking, and if you took your study medications.

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.

To enroll, call or text 206-773-7129 or email actu@uw.edu.

Courtesy of ACTU

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