Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Tytuł:: Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.
Autorzy:: Geleris J; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Sun Y; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Platt J; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Zucker J; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Baldwin M; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Hripcsak G; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Labella A; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Manson DK; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Kubin C; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Barr RG; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Sobieszczyk ME; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Schluger NW; From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
Źródło:: The New England journal of medicine [N Engl J Med] 2020 Jun 18; Vol. 382 (25), pp. 2411-2418. Date of Electronic Publication: 2020 May 07.
Typ publikacji:: Journal Article; Observational Study; Research Support, N.I.H., Extramural
Język:: English
Imprint Name(s):: Original Publication: Boston, Massachusetts Medical Society.
MeSH Terms:: Treatment Failure*
Coronavirus Infections/*drug therapy
Hydroxychloroquine/*therapeutic use
Intubation/*statistics & numerical data
Pneumonia, Viral/*drug therapy
Adult ; Aged ; Aged, 80 and over ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/mortality ; Female ; Hospitalization ; Humans ; Male ; Middle Aged ; New York City ; Pandemics ; Pneumonia, Viral/mortality ; Propensity Score ; SARS-CoV-2 ; COVID-19 Drug Treatment
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Grant Information:: R01 LM006910 United States LM NLM NIH HHS; R01 HL077612 United States HL NHLBI NIH HHS; R01 HL093081 United States HL NHLBI NIH HHS; R01 HL121270 United States HL NHLBI NIH HHS; RO1-LM006910 United States NH NIH HHS; RO1-HL121270 United States NH NIH HHS; RO1-HL093081 United States NH NIH HHS; RO1-HL077612 United States NH NIH HHS
Substance Nomenclature:: 4QWG6N8QKH (Hydroxychloroquine)
Entry Date(s):: Date Created: 20200508 Date Completed: 20200626 Latest Revision: 20231123
Update Code:: 20240105
PubMed Central ID:: PMC7224609
DOI:: 10.1056/NEJMoa2012410
PMID:: 32379955
: Czasopismo naukowe

Background: Hydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use.
Methods: We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City. Data were obtained regarding consecutive patients hospitalized with Covid-19, excluding those who were intubated, died, or discharged within 24 hours after presentation to the emergency department (study baseline). The primary end point was a composite of intubation or death in a time-to-event analysis. We compared outcomes in patients who received hydroxychloroquine with those in patients who did not, using a multivariable Cox model with inverse probability weighting according to the propensity score.
Results: Of 1446 consecutive patients, 70 patients were intubated, died, or discharged within 24 hours after presentation and were excluded from the analysis. Of the remaining 1376 patients, during a median follow-up of 22.5 days, 811 (58.9%) received hydroxychloroquine (600 mg twice on day 1, then 400 mg daily for a median of 5 days); 45.8% of the patients were treated within 24 hours after presentation to the emergency department, and 85.9% within 48 hours. Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloroquine (median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen, 223 vs. 360). Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32). Results were similar in multiple sensitivity analyses.
Conclusions: In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed. (Funded by the National Institutes of Health.).
(Copyright © 2020 Massachusetts Medical Society.)

Comment in: N Engl J Med. 2020 Jun 18;382(25):2461-2462. (PMID: 32379956)
Comment in: Rev Med Suisse. 2020 Jul 15;16(700):1388-1389. (PMID: 32672019)
Comment in: Rev Esp Cardiol (Engl Ed). 2020 Nov;73(11):964-966. (PMID: 32792314)
Comment in: Front Immunol. 2020 Aug 04;11:1739. (PMID: 32849619)

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