About: Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France

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About: Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France
Creator	Caumes, Eric Dessap, Armand Audureau, Etienne Bellamine, Ali Bernaux, Mélodie Garcelon, Nicolas Gramfort, Alexandre Grisel, Olivier Josse, Julie Lapidus, Nathanaël Lavielle, Marc Lemaitre, Guillaume Lerner, Ivan Meyer, Imke Moreau, Thomas Neuraz, Antoine Paris, Nicolas Rance, Bastien Sbidian, Emilie Varoquaux, Gaël Wolkenstein, Pierre
source	MedRxiv
abstract	Objective To assess the clinical effectiveness of oral hydroxychloroquine (HCQ) with or without azithromycin (AZI) in preventing death or leading to hospital discharge. Design Retrospective cohort study. Setting An analysis of data from electronic medical records and administrative claim data from the French Assistance Publique - Hopitaux de Paris (AP-HP) data warehouse, in 39 public hospitals, Ile-de-France, France. Participants All adult inpatients with at least one PCR-documented SARS-CoV-2 RNA from a nasopharyngeal sample between February 1st, 2020 and April 6th, 2020 were eligible for analysis. The study population was restricted to patients who did not receive COVID-19 treatments assessed in ongoing trials, including antivirals and immunosuppressive drugs. End of follow-up was defined as the date of death, discharge home, day 28 after admission, whichever occurred first, or administrative censoring on May 4, 2020. Intervention Patients were further classified into 3 groups: (i) receiving HCQ alone, (ii) receiving HCQ together with AZI, and (iii) receiving neither HCQ nor AZI. Exposure to a HCQ/AZI combination was defined as a simultaneous prescription of the 2 treatments (more or less one day). Main outcome measures The primary outcome was all-cause 28-day mortality as a time-to-event endpoint under a competing risks survival analysis framework. The secondary outcome was 28-day discharge home. Augmented inverse probability of treatment weighted (AIPTW) estimates of the average treatment effect (ATE) were computed to account for confounding. Results A total of 4,642 patients (mean age: 66.1 +/- 18; males: 2,738 (59%)) were included, of whom 623 (13.4%) received HCQ alone, 227 (5.9%) received HCQ plus AZI, and 3,792 (81.7%) neither drug. Patients receiving %22HCQ alone%22 or %22HCQ plus AZI%22 were more likely younger, males, current smokers and overall presented with slightly more co-morbidities (obesity, diabetes, any chronic pulmonary diseases, liver diseases), while no major difference was apparent in biological parameters. After accounting for confounding, no statistically significant difference was observed between the %22HCQ%22 and %22Neither drug%22 groups for 28-day mortality: AIPTW absolute difference in ATE was +1.24% (-5.63 to 8.12), ratio in ATE 1.05 (0.77 to 1.33). 28-day discharge rates were statistically significantly higher in the %22HCQ%22 group: AIPTW absolute difference in ATE (+11.1% [3.30 to 18.9]), ratio in ATE (1.25 [1.07 to 1.42]). As for the %22HCQ+AZI%22 vs neither drug, trends for significant differences and ratios in AIPTW ATE were found suggesting higher mortality rates in the former group (difference in ATE +9.83% [-0.51 to 20.17], ratio in ATE 1.40 [0.98 to 1.81];p=0.062). Conclusions Using a large non-selected population of inpatients hospitalized for COVID-19 infection in 39 hospitals in France and robust methodological approaches, we found no evidence for efficacy of HCQ or HCQ combined with AZI on 28-day mortality. Our results suggested a possible excess risk of mortality associated with HCQ combined with AZI, but not with HCQ alone. Significantly higher rates of discharge home were observed in patients treated by HCQ, a novel finding warranting further confirmation in replicative studies. Altogether, our findings further support the need to complete currently undergoing randomized clinical trials.
has issue date	2020-06-19(xsd:dateTime)
bibo:doi	10.1101/2020.06.16.20132597
has license	medrxiv
sha1sum (hex)	a2fce0b31118c4df6ba6f629af6e53883fd0fe43
schema:url	https://doi.org/10.1101/2020.06.16.20132597
resource representing a document's title	Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France
resource representing a document's body	covid:a2fce0b31118c4df6ba6f629af6e53883fd0fe43#body_text
is schema:about of	named entity 'consortium' named entity 'azithromycin' named entity 'cohort study' named entity 'medRxiv' named entity 'preprint' named entity 'preprint' named entity 'HCQ' named entity 'HCQ' named entity 'causal inference' named entity 'clinical outcome' named entity 'probability' named entity 'SARS-CoV-2' named entity 'anti-inflammatory' named entity 'D-Dimer' named entity 'ischaemic' named entity 'survival analyses' named entity 'electronic health record' named entity 'anakinra' named entity 'average treatment effect' named entity 'statistically significant' named entity 'preprint' named entity 'AP-HP' named entity 'HCQ' named entity 'risk of death' named entity 'mortality rates' named entity 'HCQ' named entity 'ATE' named entity 'COVID' named entity 'inflammatory' named entity 'risk of death' named entity 'viral load' named entity 'medRxiv' named entity 'remdesivir' named entity 'copyright holder' named entity 'copyright holder' named entity 'HCQ' named entity 'COVID' named entity 'viral load' named entity 'remdesivir' named entity 'HCQ' named entity 'ICD-10' named entity 'HCQ' named entity 'cumulative incidence' named entity 'HCQ' named entity 'Data model' named entity 'causal inference' named entity 'diabetes' named entity 'HCQ' named entity 'COVID' named entity 'immunomodulatory' named entity 'HCQ' named entity 'in-patients' named entity 'COVID' named entity 'infection' named entity 'human immunodeficiency viruses' named entity 'causal inference' named entity 'HCQ' named entity 'study population' named entity 'clinical trial' named entity 'non-specific' named entity 'antimalarials' named entity 'antiviral' named entity 'ATE' named entity 'France' named entity 'Inserm'

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