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0 0.5 1 1.5 2+ Mortality 18% Improvement Relative Risk Mortality (b) -84% c19hcq.org Soto-Becerra et al. HCQ for COVID-19 LATE TREATMENT Is late treatment with HCQ beneficial for COVID-19? Retrospective 3,322 patients in Peru (April - July 2020) Lower mortality with HCQ (p<0.000001) Soto-Becerra et al., medRxiv, doi:10.1101/2020.10.06.20208066 Favors HCQ Favors control
Real-World Effectiveness of hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19 patients: Results of a target trial emulation using observational data from a nationwide Healthcare System in Peru
Soto-Becerra et al., medRxiv, doi:10.1101/2020.10.06.20208066 (Preprint)
Soto-Becerra et al., Real-World Effectiveness of hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19.., medRxiv, doi:10.1101/2020.10.06.20208066 (Preprint)
Oct 2020   Source   PDF  
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Retrospective database study of 5683 patients, 692 received HCQ/CQ+AZ, 200 received HCQ/CQ, 203 received ivermectin, 1600 received AZ, 358 received ivermectin+AZ, and 2630 received standard of care.
This study includes anyone with ICD-10 COVID-19 codes which includes asymptomatic PCR+ patients, therefore many patients in the control group are likely asymptomatic with regards to SARS-CoV-2, but in the hospital for another reason. For those that had symptomatic COVID-19, there is also likely significant confounding by indication.
In this study all medications show higher mortality at day 30, which is consistent with asymptomatic (for COVID-19) or mild condition patients being more common in the control group.
For ivermectin they show 30 day mortality aHR = 1.39 [0.88 - 2.22]. KM curves show that the treatment groups were in more serious condition, and also that after about day 35 survival became better with ivermectin. The last day available for ivermectin shows RR 0.83, p = 0.01. More than the total excess mortality happened on the first day. This is consistent with treated patients being in more serious condition, and with many of the control group patients being in hospital for something unrelated to COVID-19.
Authors use a machine learning based propensity scoring system that appears over-parameterized and likely to result in significant overfitting and inaccurate results. Essentially they test for all interactions between two and three covariates. The nature and large number of covariates means many random correlations may be found. COVID-19 severity is not used.
This study also does not compare treatments with a control group not receiving the treatment - authors put patients receiving treatments after 48 hours in the control group.
Authors state that outcomes within 24 hours were excluded, however KM curves show significant mortality at day 1 (only for the treatment groups).
Several protocol violations and missing data have also been reported in this study: [trialsitenews.com, trialsitenews.com (B)].
See also: [twitter.com].
Ivermectin dosage details: [cdn.www.gob.pe] This study is excluded in the after exclusion results of meta analysis: substantial unadjusted confounding by indication likely; includes PCR+ patients that may be asymptomatic for COVID-19 but in hospital for other reasons.
risk of death, 18.1% lower, HR 0.82, p < 0.001, treatment 346 of 692 (50.0%), control 1,606 of 2,630 (61.1%), NNT 9.0, day 54 (last day available) weighted KM.
risk of death, 84.0% higher, HR 1.84, p = 0.02, treatment 165 of 692 (23.8%), control 401 of 2,630 (15.2%), adjusted per study, day 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Soto-Becerra et al., 8 Oct 2020, retrospective, database analysis, Peru, preprint, median age 59.4, 4 authors, study period 1 April, 2020 - 19 July, 2020.
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Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.10.06.20208066; this version posted October 8, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . TITLE: Real-World Effectiveness of hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19 patients: Results of a target trial emulation using observational data from a nationwide Healthcare System in Peru Short Title: Target trial emulation of hydroxychloroquine, azithromycin, ivermectin. Authors: Percy Soto-Becerra1 Carlos Culquichicón1 Yamilee Hurtado-Roca1 Roger V. Araujo-Castillo1 Affiliations: 1 Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud, Lima, Peru. Corresponding author: Roger V. Araujo-Castillo Arenales Av. 1302, Office 310, Jesus Maria, Lima, Peru Phone number 51(1) 265-6000 - Extension 1955 araujocaroger@gmail.com Financial statement: This study was funded by the Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud – Peru. Conflicts of interest: The authors declare no conflicts of interest regarding the subject of this scientific article. NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.10.06.20208066; this version posted October 8, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . ABSTRACT Introduction: In Latin America, Peru is the most impacted country due to COVID-19 pandemic. Given the authorized nationwide use of hydroxychloroquine, azithromycin, ivermectin and dexamethasone in COVID-19 patients, we aimed to evaluate their effectiveness alone or combined to prevent 30-day mortality among COVID-19 hospitalized patients without life-threatening illness. Methods: Design. Retrospective cohort study using digital clinical records to emulate a target trial. Setting. Nationwide data of mid- and high-level complexity hospitals from the Peruvian Social Health Insurance (EsSalud) between April 1 and July 19, 2020. Participants. Patients aged 18 years with confirmed SARS-CoV-2 infection by PCR, and non-severe pneumonia at admission. Interventions. We compared five treatment groups to the standard of care treatment regimen (control group) within 48 hours of admission to hospital: hydroxychloroquine/chloroquine alone (HCQ), ivermectin alone (IVM), azithromycin alone (AZIT), HCQ + AZIT group, and IVM + AZIT group with doses recommended by the Peruvian Ministry of Health. Main outcomes measures. The primary outcome was all-cause mortality rate, the secondary outcomes were survival without ICU rate, and survival without oxygen prescription rate. Analyses were adjusted for confounding factors by inverse probability of treatment weighting. A doubly-adjustment method was done for sensitivity analysis. Results: Among 5683 patients eligible for analysis, 200 received hydroxychloroquine or chloroquine within 48 hours of hospital admission, 203 received ivermectin, 1600 received azithromycin, 692 received hydroxychloroquine or chloroquine plus azithromycin, 358 received..
Late treatment
is less effective
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