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Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.
N Engl J Med. 2020 06 18; 382(25):2411-2418.NEJM

Abstract

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.).

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Authors+Show Affiliations

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.

MeSH

AdultAgedAged, 80 and overBetacoronavirusCOVID-19Coronavirus InfectionsFemaleHospitalizationHumansHydroxychloroquineIntubationMaleMiddle AgedNew York CityPandemicsPneumonia, ViralPropensity ScoreSARS-CoV-2Treatment FailureCOVID-19 Drug Treatment

Pub Type(s)

Journal Article
Observational Study
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

32379955

Clinical Trial Links

Tafenoquine in Patients With Mild to Moderate COVID-19
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection
Multi-site Adaptive Trials for COVID-19
Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

Citation

Geleris, Joshua, et al. "Observational Study of Hydroxychloroquine in Hospitalized Patients With Covid-19." The New England Journal of Medicine, vol. 382, no. 25, 2020, pp. 2411-2418.
Geleris J, Sun Y, Platt J, et al. Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. 2020;382(25):2411-2418.
Geleris, J., Sun, Y., Platt, J., Zucker, J., Baldwin, M., Hripcsak, G., Labella, A., Manson, D. K., Kubin, C., Barr, R. G., Sobieszczyk, M. E., & Schluger, N. W. (2020). Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. The New England Journal of Medicine, 382(25), 2411-2418. https://doi.org/10.1056/NEJMoa2012410
Geleris J, et al. Observational Study of Hydroxychloroquine in Hospitalized Patients With Covid-19. N Engl J Med. 2020 06 18;382(25):2411-2418. PubMed PMID: 32379955.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. AU - Geleris,Joshua, AU - Sun,Yifei, AU - Platt,Jonathan, AU - Zucker,Jason, AU - Baldwin,Matthew, AU - Hripcsak,George, AU - Labella,Angelena, AU - Manson,Daniel K, AU - Kubin,Christine, AU - Barr,R Graham, AU - Sobieszczyk,Magdalena E, AU - Schluger,Neil W, Y1 - 2020/05/07/ PY - 2020/5/8/pubmed PY - 2020/6/27/medline PY - 2020/5/8/entrez SP - 2411 EP - 2418 JF - The New England journal of medicine JO - N Engl J Med VL - 382 IS - 25 N2 - 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/32379955/full_citation DB - PRIME DP - Unbound Medicine ER -
High [↓948 ↑10]

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