Evidence map›Paper›PMID 32379955›Full record

Observational studyThe New England journal of medicine2020

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

Joshua Geleris, Yifei Sun, Jonathan Platt, Jason Zucker, Matthew Baldwin, George Hripcsak, Angelena Labella, Daniel K Manson, Christine Kubin, R Graham Barr and 2 more

5 registry-linked trialsAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The New England journal of medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 965 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
965citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04340349 early_phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial)

TypeinterventionalSponsorInstituto Nacional de RehabilitacionRan2021 to 2021Enrolled214ConditionsHydroxychloroquine, Antimalarials, Enzyme Inhibitors, Antirheumatic AgentsArmsHydroxychloroquine Sulfate, Bromhexine 8 MG
NCT04370262 phase3completednot on this map

A Multi-site, Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Standard of Care (SOC) Plus Famotidine vs SOC Plus Placebo for the Treatment of COVID-19 in Hospitalized Adults

TypeinterventionalSponsorNorthwell HealthRan2020 to 2020Enrolled233ConditionsCOVID-19ArmsSOC + Intravenous Famotidine, SOC + Placebo
NCT04391127 phase3completednot on this map

Efficacy and Safety of Hydroxychloroquine and Ivermectin in Hospitalized no Critical Patients Secondary to COVID-19 Infection: Randomized Controlled Trial

TypeinterventionalSponsorCentenario Hospital Miguel HidalgoRan2020 to 2020Enrolled108ConditionsCOVID-19ArmsHydroxychloroquine, Ivermectin, Placebo
NCT04533347 phase2completednot on this mapstarted 2021, after this paper: background citation

A Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Oral Tafenoquine Versus Placebo in Patients With Mild to Moderate COVID-19 Disease

TypeinterventionalSponsor60 Degrees Pharmaceuticals LLCRan2021 to 2022Enrolled86ConditionsCOVID 19 DiseaseArmsTafenoquine Oral Tablet, Placebo
NCT04724720 phase2completednot on this mapstarted 2021, after this paper: background citation

A Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Famotidine vs Placebo for the Treatment of Non-Hospitalized Symptomatic Adults With COVID-19

TypeinterventionalSponsorNorthwell HealthRan2021 to 2022Enrolled56ConditionsCovid-19ArmsFamotidine, Placebo
3 · Its place in the literature

Who cites it

965 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  7. Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021
    Pooled it
  8. Effectiveness of favipiravir in COVID-19: a live systematic review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021
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905 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Joshua GelerisFrom 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.
Yifei SunFrom 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.
Jonathan PlattFrom 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.
Jason ZuckerFrom 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.
Matthew BaldwinFrom 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.
George HripcsakFrom 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.
Angelena LabellaFrom 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.
Daniel K MansonFrom 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.
Christine KubinFrom 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.
R Graham BarrFrom 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.
Magdalena E SobieszczykFrom 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.
Neil W SchlugerFrom 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.

Funding

Pulmonary microvascular perfusion in the Multi-Ethnic Study of AtherosclerosisR01HL077612 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI R Graham BARR · 2004 to 2026
$18.8M
Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary Disease (COPD)R01HL093081 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI R Graham BARR · 2008 to 2026
$17.2M
DISCOVERING AND APPLYING KNOWLEDGE IN CLINICAL DATABASESR01LM006910 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HRIPCSAK, GEORGE M · 2000 to 2023
$10.6M
Novel Quantitative Emphysema Subtypes in MESA and SPIROMICSR01HL121270 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BARR, R GRAHAM, LAINE, ANDREW FRANCIS · 2014 to 2022
$5.6M
NHLBI NIH HHS R01 HL077612NHLBI NIH HHS R01 HL093081NHLBI NIH HHS R01 HL121270NIH HHS RO1-HL077612NIH HHS RO1-HL093081NIH HHS RO1-HL121270NIH HHS RO1-LM006910NLM NIH HHS R01 LM006910
6 · The paper itself

Abstract

backgroundHydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use.

methodsWe 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.

resultsOf 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.

conclusionsIn 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.).

Indexed as

Treatment FailureAdultAgedAged, 80 and overBetacoronavirusCoronavirus InfectionsCOVID-19COVID-19 Drug TreatmentFemaleHospitalizationHumansHydroxychloroquineIntubationMaleMiddle AgedNew York CityHydroxychloroquine

Identifiers

PMID32379955
PMCPMC7224609

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.