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0 0.5 1 1.5 2+ Hospitalization 12% Improvement Relative Risk Symptomatic at day 21 26% Ct<=40 at day 14 -10% HCQ  Omrani et al.  EARLY TREATMENT  RCT Is early treatment with HCQ + AZ beneficial for COVID-19? RCT 456 patients in Qatar (April - August 2020) Improved recovery with HCQ + AZ (not stat. sig., p=0.58) Omrani et al., EClinicalMedicine, November 2020 Favors HCQ Favors control

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
Nov 2020  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
*, now known with p < 0.00000000001 from 421 studies, recognized in 42 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
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 15% lower hospitalization [6‑24%] from meta analysis of the 65 hospitalization results to date.
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, study period 13 April, 2020 - 1 August, 2020, dosage 600mg days 1-6, this trial uses multiple treatments in the treatment arm (combined with AZ) - results of individual treatments may vary.
This PaperHCQAll
Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19
Ali S Omrani, Sameer A Pathan, Sarah A Thomas, Tim R E Harris, Peter V Coyle, Caroline E Thomas, Isma Qureshi, Zain A Bhutta, Naema Al Mawlawi, Reham Al Kahlout, Ashraf Elmalik, Aftab M Azad, Joanne Daghfal, Mulham Mustafa, Andrew Jeremijenko, Hussam Al Soub, Mohammed Abu Khattab, Muna Al Maslamani, Stephen H Thomas
EClinicalMedicine, doi:10.1016/j.eclinm.2020.100645
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 x 2 testing. ( 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.
Author contributions Authors have made the following contributions consistent with ICJME recommendations for authorship: All authors made meaningful contributions to manuscript preparation, review, and editing. In addition, the authors made contributions as follows: -Stephen H. Thomas conceived the study, co-wrote the draft manuscript, and maintains overall responsibility for Q-PROTECT conduct and reporting. -Ali S. Omrani made critical contributions/modifications to the study design and execution plans, and co-wrote the initial manuscript draft. -Sameer A. Pathan led the execution stage of the study. -Sarah A. Thomas planned the randomization and allocation concealment approaches, performed the literature search and initialdraft manuscript writing relevant to cell biology of putative drug action mechanisms, executed data-sharing processes, and assisted with revision of the manuscript during the editorial review process. -Peter V. Coyle led the virology testing planning and execution and made key manuscript contributions in the arena of laboratory medicine. -Naema Al Mawlawi and Reham Al Kahlout managed the lab specimens, executed all PCR analysis, and arranged virologic reporting data -Tim R. E. Harris provided substantial manuscript editing, and coordinated physician resourcing for study participant accrual and data processing. -Caroline E. Thomas led planning of, and manuscript writing describing, data entry spreadsheet/source-table preparing of participants' data entry..
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Who, Solidarity" clinical trial for Covid-19 treatments
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