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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% c19hcq.org Rodrigues et al. HCQ for COVID-19 RCT EARLY TREATMENT 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
Rodrigues et al., Hydroxychloroquine plus azithromycin early treatment of mild COVID-19 in outpatient setting: a randomized,.., International Journal of Antimicrobial Agents, doi:10.1016/j.ijantimicag.2021.106428
Aug 2021   Source   PDF  
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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, 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.
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Abstract: International Journal of Antimicrobial Agents 58 (2021) 106428 Contents lists available at ScienceDirect International Journal of Antimicrobial Agents journal homepage: www.elsevier.com/locate/ijantimicag 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 a,∗, Rodrigo S. Freitas-Santos b,∗∗, José Eduardo Levi c, Andreza A. Senerchia d, Ana Tarina A. Lopes b, Sergio R. Santos e, Rinaldo F. Siciliano f, Lígia C. Pierrotti g,h a Hospital Infection Control Committee, Hospital Santa Paula, Ímpar Serviços Hospitalares S.A., São Paulo, São Paulo, Brazil Institute for Education and Research, Hospital Santa Paula, Ímpar Serviços Hospitalares S.A., São Paulo, São Paulo, Brazil c Research and Development Department, Diagnósticos da América S.A. (Dasa), Brazil d Clinical Research Department, Diagnósticos da América S.A. (Dasa), Brazil e Strategy Board, Diagnósticos da América S.A. (Dasa), Brazil f Heart Institute (InCor), Medical School, Universidade de São Paulo, São Paulo, São Paulo, Brazil g Infectious Diseases Division, Hospital das Clínicas, Universidade de São Paulo, São Paulo, São Paulo, Brazil h Infectious Diseases Department, Diagnósticos da América S.A. (Dasa), Brazil b a r t i c l e i n f o Article history: Received 3 November 2020 Accepted 13 August 2021 Editor: Dr Jim Gray Keywords: COVID-19 SARS-CoV-2 RCT Hydroxychloroquine Azithromycin a b s t r a c t 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..
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