Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis.

Autor:	Di Stefano L; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Ogburn EL; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Ram M; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Scharfstein DO; Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah., Li T; University of Colorado Denver, Anschutz Medical Campus, Denver, Colorado., Khanal P; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland., Baksh SN; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., McBee N; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland., Gruber J; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland., Gildea MR; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland.; Current address: FHI 360, Durham, North Carolina., Clark MR; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland., Goldenberg NA; Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland.; Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.; Johns Hopkins All Children's Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida., Bennani Y; Louisiana State University Health Sciences Center, New Orleans, Louisiana.; University Medical Center, New Orleans, New Orleans, Louisiana., Brown SM; Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.; University of Utah, Salt Lake City, Utah., Buckel WR; Pharmacy Services, Intermountain Healthcare, Murray, Utah., Clement ME; Louisiana State University Health Sciences Center, New Orleans, Louisiana.; University Medical Center, New Orleans, New Orleans, Louisiana., Mulligan MJ; Department of Medicine, Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York.; Vaccine Center, New York University Grossman School of Medicine, New York, New York., O'Halloran JA; Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri., Rauseo AM; Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri., Self WH; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee., Semler MW; Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee., Seto T; Department of Medicine, University of Hawaii John A. Burns School of Medicine, Honolulu, Hawaii., Stout JE; Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina., Ulrich RJ; Department of Medicine, Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York., Victory J; Bassett Research Institute, Bassett Medical Center, Cooperstown, New York., Bierer BE; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts., Hanley DF; Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, Maryland., Freilich D; Department of Internal Medicine, Division of Infectious Diseases, Bassett Medical Center, Cooperstown, New York.
Jazyk:	angličtina
Zdroj:	MedRxiv : the preprint server for health sciences [medRxiv] 2022 Aug 16. Date of Electronic Publication: 2022 Aug 16.
DOI:	10.1101/2022.01.10.22269008
Abstrakt:	Background: Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. Methods: We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Results: Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions: The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.
Databáze:	MEDLINE
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