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Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 EClinicalMedicine 2020 ; 29 (ä): 100645 Nephropedia Template TP
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Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19 #MMPMID33251500
Omrani AS; Pathan SA; Thomas SA; Harris TRE; Coyle PV; Thomas CE; Qureshi I; Bhutta ZA; Mawlawi NA; Kahlout RA; Elmalik A; Azad AM; Daghfal J; Mustafa M; Jeremijenko A; Soub HA; Khattab MA; Maslamani MA; Thomas SH
EClinicalMedicine 2020[Dec]; 29 (ä): 100645 PMID33251500show ga
BACKGROUND: Hydroxychloroquine (HC) +/- azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC+/-AZ in cases of low-acuity Covid-19. METHODS: Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and chi(2) testing. (ClinicalTrials.gov NCT04349592, trial status closed to new participants.). FINDINGS: The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3.9%), 7 (4.6%), and 9 (5.9%) participants go off study medications before completing the medication course (p = 0.716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98.0%) HC participants, and 147/152 (96.7%) placebo participants. Day six ITT analysis found no difference (p = 0.821) in groups' proportions achieving virologic cure: HC+AZ 16/152 (10.5%), HC 19/149 (12.8%), placebo 18/147 (12.2%). Day 14 assessment also showed no association (p = 0.072) between study group and viral cure: HC+AZ 30/149 (20.1%,), HC 42/146 (28.8%), placebo 45/143 (31.5%). There were no serious adverse events. INTERPRETATION: HC+/-AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19. FUNDING: The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).