Omrani: Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19 [HCQ]

Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19

Omrani et al., EClinicalMedicine, doi:10.1016/j.eclinm.2020.100645

Omrani et al., Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for.., EClinicalMedicine, doi:10.1016/j.eclinm.2020.100645

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Low risk patient RCT for HCQ+AZ and HCQ vs. control, not showing any significant differences.

Authors note that the results are not applicable to higher risk patients, that positive PCR may simply reflect detection of inactive (non-infectious) viral remnants, that an alternative dosage regimen may be more effective, and that medication adherence was unknown.

HCQ dosing was 600mg/day for 1 week, therapeutic levels may not be reached for several days. There were no deaths or serious adverse events.

Although the 12% lower hospitalization is not statistically significant, it is consistent with the significant 16% lower hospitalization [6‑24%] from meta analysis of the 59 hospitalization results to date.

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risk of hospitalization, 12.5% lower, RR 0.88, p = 1.00, treatment 7 of 304 (2.3%), control 4 of 152 (2.6%), NNT 304, HCQ+AZ or HCQ vs. control.

risk of symptomatic at day 21, 25.8% lower, RR 0.74, p = 0.58, treatment 9 of 293 (3.1%), control 6 of 145 (4.1%), NNT 94, HCQ+AZ or HCQ vs. control.

risk of Ct<=40 at day 14, 10.3% higher, RR 1.10, p = 0.13, treatment 223 of 295 (75.6%), control 98 of 143 (68.5%), HCQ+AZ or HCQ vs. control.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Omrani et al., 20 Nov 2020, Randomized Controlled Trial, Qatar, peer-reviewed, 19 authors, dosage 600mg days 1-6, this trial uses multiple treatments in the treatment arm (combined with AZ) - results of individual treatments may vary.

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Abstract: EClinicalMedicine 29 30 (2020) 100645 Contents lists available at ScienceDirect EClinicalMedicine journal homepage: https://www.journals.elsevier.com/eclinicalmedicine Research Paper Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19 Ali S. Omrania,1, Sameer A. Pathanb,c,d,1, Sarah A. Thomase, Tim R.E. Harrisb,c, Peter V. Coylef, Caroline E. Thomasb, Isma Qureshib, Zain A. Bhuttab, Naema Al Mawlawif, Reham Al Kahloutf, Ashraf Elmalikg, Aftab M. Azadb, Joanne Daghfala, Mulham Mustafaa, Andrew Jeremijenkoa, Hussam Al Souba, Mohammed Abu Khattaba, Muna Al Maslamania,h, Stephen H. Thomasb,c,* a Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar c Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK d School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia e BSc Candidate in Medical Biosciences, Faculty of Medicine, Imperial College London, UK f Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha g Department of Pharmacy, Hamad General Hospital, Doha, Qatar h Department of Medicine, Weill Cornell Medical College in Qatar, Doha, Qatar b A R T I C L E I N F O Article History: Received 5 September 2020 Revised 27 October 2020 Accepted 29 October 2020 Available online 20 November 2020 Keywords: Hyodroxychloroquine Covid-19 Azithromycin A B S T R A C T 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, intentto-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% conﬁdence intervals (CIs) and x2 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..

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