Compassionate Use of Hydroxychloroquine in Clinical Practice for Patients With Mild to Severe COVID-19 in a French University Hospital.


Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
06 12 2021
Historique:
received: 15 04 2020
pubmed: 20 6 2020
medline: 15 12 2021
entrez: 20 6 2020
Statut: ppublish

Résumé

Data from nonrandomized studies have suggested that hydroxychloroquine could be an effective therapeutic agent against coronavirus disease 2019 (COVID-19). We conducted an observational, retrospective cohort study involving hospitalized adult patients with confirmed, mild to severe COVID-19 in a French university hospital. Patients who received hydroxychloroquine (200 mg 3 times daily dosage for 10 days) on a compassionate basis in addition to standard of care (SOC) were compared with patients without contraindications to hydroxychloroquine who received SOC alone. A propensity score-weighted analysis was performed to control for confounders: age, sex, time between symptom onset and admission ≤ 7 days, Charlson comorbidity index, medical history of arterial hypertension, obesity, National Early Warning Score 2 (NEWS2) score at admission, and pneumonia severity. The primary endpoint was time to unfavorable outcome, defined as: death, admission to an intensive care unit, or decision to withdraw or withhold life-sustaining treatments, whichever came first. Data from 89 patients with laboratory-confirmed COVID-19 were analyzed, 84 of whom were considered in the primary analysis; 38 patients treated with hydroxychloroquine and 46 patients treated with SOC alone. At admission, the mean age of patients was 66 years, the median Charlson comorbidity index was 3, and the median NEWS2 severity score was 3. After propensity score weighting, treatment with hydroxychloroquine was not associated with a significantly reduced risk of unfavorable outcome (hazard ratio, 0.90 [95% confidence interval, .38-2.1], P = .81). Overall survival was not significantly different between the 2 groups (hazard ratio, 0.89 [0.23; 3.47], P = 1). In hospitalized adults with COVID-19, no significant reduction of the risk of unfavorable outcomes was observed with hydroxychloroquine in comparison to SOC. Unmeasured confounders may have persisted however, despite careful propensity-weighted analysis and the study might be underpowered. Ongoing controlled trials in patients with varying degrees of initial severity on a larger scale will help determine whether there is a place for hydroxychloroquine in the treatment of COVID-19. In hospitalized adults with COVID-19, no significant reduction of the risk of unfavorable outcomes was observed with hydroxychloroquine in comparison to SOC.

Sections du résumé

BACKGROUND
Data from nonrandomized studies have suggested that hydroxychloroquine could be an effective therapeutic agent against coronavirus disease 2019 (COVID-19).
METHODS
We conducted an observational, retrospective cohort study involving hospitalized adult patients with confirmed, mild to severe COVID-19 in a French university hospital. Patients who received hydroxychloroquine (200 mg 3 times daily dosage for 10 days) on a compassionate basis in addition to standard of care (SOC) were compared with patients without contraindications to hydroxychloroquine who received SOC alone. A propensity score-weighted analysis was performed to control for confounders: age, sex, time between symptom onset and admission ≤ 7 days, Charlson comorbidity index, medical history of arterial hypertension, obesity, National Early Warning Score 2 (NEWS2) score at admission, and pneumonia severity. The primary endpoint was time to unfavorable outcome, defined as: death, admission to an intensive care unit, or decision to withdraw or withhold life-sustaining treatments, whichever came first.
RESULTS
Data from 89 patients with laboratory-confirmed COVID-19 were analyzed, 84 of whom were considered in the primary analysis; 38 patients treated with hydroxychloroquine and 46 patients treated with SOC alone. At admission, the mean age of patients was 66 years, the median Charlson comorbidity index was 3, and the median NEWS2 severity score was 3. After propensity score weighting, treatment with hydroxychloroquine was not associated with a significantly reduced risk of unfavorable outcome (hazard ratio, 0.90 [95% confidence interval, .38-2.1], P = .81). Overall survival was not significantly different between the 2 groups (hazard ratio, 0.89 [0.23; 3.47], P = 1).
CONCLUSION
In hospitalized adults with COVID-19, no significant reduction of the risk of unfavorable outcomes was observed with hydroxychloroquine in comparison to SOC. Unmeasured confounders may have persisted however, despite careful propensity-weighted analysis and the study might be underpowered. Ongoing controlled trials in patients with varying degrees of initial severity on a larger scale will help determine whether there is a place for hydroxychloroquine in the treatment of COVID-19. In hospitalized adults with COVID-19, no significant reduction of the risk of unfavorable outcomes was observed with hydroxychloroquine in comparison to SOC.

Identifiants

pubmed: 32556143
pii: 5859555
doi: 10.1093/cid/ciaa791
pmc: PMC7337663
doi:

Substances chimiques

Hydroxychloroquine 4QWG6N8QKH

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

e4064-e4072

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Olivier Paccoud (O)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Florence Tubach (F)

Sorbonne Université, INSERM UMR 1136, Département de Santé Publique, Unité de Recherche Clinique Pitié Salpêtrière - Charles Foix, Centre de Pharmaco-épidémiologie de l'AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Paris, France.

Amandine Baptiste (A)

Sorbonne Université, INSERM UMR 1136, Département de Santé Publique, Unité de Recherche Clinique Pitié Salpêtrière - Charles Foix, Centre de Pharmaco-épidémiologie de l'AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Paris, France.

Alexandre Bleibtreu (A)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

David Hajage (D)

Sorbonne Université, INSERM UMR 1136, Département de Santé Publique, Unité de Recherche Clinique Pitié Salpêtrière - Charles Foix, Centre de Pharmaco-épidémiologie de l'AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Paris, France.

Gentiane Monsel (G)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Gianpiero Tebano (G)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

David Boutolleau (D)

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, laboratoire de virologie, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

Elise Klement (E)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Nagisa Godefroy (N)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Romain Palich (R)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Oula Itani (O)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Antoine Faiçal (A)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Marc-Antoine Valantin (MA)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Roland Tubiana (R)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.

Sonia Burrel (S)

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, laboratoire de virologie, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

Vincent Calvez (V)

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, laboratoire de virologie, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

Eric Caumes (E)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

Anne-Geneviève Marcelin (AG)

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, laboratoire de virologie, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

Valérie Pourcher (V)

Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Pitié-Salpêtrière Charles Foix, Service de Maladies infectieuses et Tropicales, Paris, France.
Sorbonne Université, INSERM 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

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