NCT04349592

Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
DRUG	Azithromycin	Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
OTHER	Placebo Tablet	Oral, one tablet three times a day for 7 days
OTHER	Placebo capsules	Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-08-14
• Completion: 2020-08-30
• First posted: 2020-04-16
• Last updated: 2021-02-23

Locations

1 site across 1 country: Qatar