Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
456
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Oral, one tablet three times a day for 7 days
Hamad Medical Corporation
Doha, Qatar
Proportion of virologically cured (PCR-negative status) as assessed on day six
Days
Time frame: Day 6
virologic cure on other study days
Days
Time frame: Day14 and Day 21
virologic semiquantitative analysis of changing viral load
Days
Time frame: Day 1 to Day 21
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Days
Time frame: Day14 and Day 21
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Days
Time frame: Day14 and Day 21
proportions of subjects with potentially medication- related adverse events
grades
Time frame: 7 day
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Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.