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0 0.5 1 1.5 2+ Hospitalization -200% Improvement Relative Risk Viral clearance 14% Viral clearance (b) 13% Viral clearance (c) 23% Viral clearance (d) 3% Viral clearance (e) 0% Viral clearance (f) 6% Time to viral- 9% Time to viral- (b) 1% HCQ  Rodrigues et al.  EARLY TREATMENT  DB RCT Is early treatment with HCQ + AZ beneficial for COVID-19? Double-blind RCT 84 patients in Brazil (April - May 2020) Improved viral clearance with HCQ + AZ (not stat. sig., p=0.15) Rodrigues et al., Int. J. Antimicrobia.., Aug 2021 Favors HCQ Favors control

Hydroxychloroquine plus azithromycin early treatment of mild COVID-19 in outpatient setting: a randomized, double-blinded, placebo-controlled clinical trial evaluating viral clearance

Rodrigues et al., International Journal of Antimicrobial Agents, doi:10.1016/j.ijantimicag.2021.106428
Aug 2021  
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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.
RCT 84 low risk patients, 42 treated with HCQ/AZ, showing no significant differences. There was only one hospitalization which was in the treatment arm.
risk of hospitalization, 200.0% higher, RR 3.00, p = 1.00, treatment 1 of 42 (2.4%), control 0 of 42 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of no viral clearance, 14.4% lower, RR 0.86, p = 0.15, treatment 29 of 36 (80.6%), control 32 of 34 (94.1%), NNT 7.4, PP, day 3.
risk of no viral clearance, 13.1% lower, RR 0.87, p = 0.45, treatment 23 of 36 (63.9%), control 25 of 34 (73.5%), NNT 10, PP, day 6.
risk of no viral clearance, 23.3% lower, RR 0.77, p = 0.47, treatment 13 of 36 (36.1%), control 16 of 34 (47.1%), NNT 9.1, PP, day 9.
risk of no viral clearance, 3.1% lower, RR 0.97, p = 1.00, treatment 31 of 42 (73.8%), control 32 of 42 (76.2%), NNT 42, ITT, day 3.
risk of no viral clearance, no change, RR 1.00, p = 1.00, treatment 25 of 42 (59.5%), control 25 of 42 (59.5%), ITT, day 6.
risk of no viral clearance, 6.2% lower, RR 0.94, p = 1.00, treatment 15 of 42 (35.7%), control 16 of 42 (38.1%), NNT 42, ITT, day 9.
time to viral-, 8.8% lower, relative time 0.91, p = 0.26, treatment 36, control 34, PP.
time to viral-, 1.4% lower, relative time 0.99, p = 0.85, treatment 42, control 42, ITT.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rodrigues et al., 25 Aug 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 8 authors, study period 12 April, 2020 - 13 May, 2020, average treatment delay 3.8 days, dosage 400mg bid days 1-7, this trial uses multiple treatments in the treatment arm (combined with AZ) - results of individual treatments may vary.
This PaperHCQAll
Hydroxychloroquine plus azithromycin early treatment of mild COVID-19 in an outpatient setting: a randomized, double-blinded, placebo-controlled clinical trial evaluating viral clearance
Cristhieni Rodrigues, Rodrigo S Freitas-Santos, José Eduardo Levi, Andreza A Senerchia, Ana Tarina A Lopes, Sergio R Santos, Rinaldo F Siciliano, Lígia C Pierrotti
International Journal of Antimicrobial Agents, doi:10.1016/j.ijantimicag.2021.106428
Background: Hydroxychloroquine has shown potential to block viral replication of SARS-CoV-2 in some in vitro studies. This randomised, double-blinded, placebo controlled clinical trial evaluated the efficacy of hydroxychloroquine plus azithromycin (HCQ/AZT) in reducing viral loads in patients with early and mild SARS-CoV-2 infection. Methods: A single-centre randomised placebo-controlled clinical trial was conducted with outpatients with early and mild SARS-CoV-2 infection. Inclusion criteria were: patients aged 18-65 years with symptoms suggestive of COVID-19 for < 5 days, no significant comorbidities, and positive nasopharyngeal/oropharyngeal swab screening tests (POCT-PCR). Randomised patients received either hydroxychloroquine for 7 days plus azithromycin for 5 days or placebo. The primary endpoint was viral clearance within a 9-day period. Secondary endpoints included viral load reduction, clinical evolution, hospitalization rates, chest computed tomography evolution, and adverse effects. Results: From 107 potential trial participants, 84 were enrolled following predetermined criteria. Statistical analyses were performed on an intention-to-treat (N = 84) and per-protocol (PP) basis (N = 70). On the PP analysis, the treatment (N = 36) and placebo (N = 34) groups displayed similar demographic characteristics. At 95% CI, no statistically significant between-group differences were found in viral clearance rates within 9 days following enrolment ( P = 0.26). Conclusions: This randomised, double-blinded, placebo-controlled clinical trial evaluating outpatients with early and mild COVID-19 showed that viral clearance rates within a 9-day period from enrolment did not change with HCQ/AZT treatment compared with placebo, although no major cardiovascular events were observed in participants without comorbidities. Secondary outcomes were also not significantly improved with HCQ/AZT treatment compared with placebo. These findings do not support use of HCQ/AZT in this setting.
DECLARATIONS Funding: This study was funded by Diagnósticos da América S.A. (Dasa), Ímpar Serviços Hospitalares S.A., and DNA Capital Foundation. Competing Interests: All authors report no conflicts of interest relevant to this article. Ethical Approval: The present study was designed as a prospective, double blinded, placebo-controlled, randomised clinical trial, in accordance with The Consolidated Standards of Reporting Trials (CONSORT) Statement, approved by the local ethics and research committee, registered at REBEC (30413020.8.0 0 0 0.0 0 08), Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi: 10.1016/j.ijantimicag.2021. 106428 .
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