Remdesivir Plus Dexamethasone Versus Dexamethasone Alone for the Treatment of Coronavirus Disease 2019 (COVID-19) Patients Requiring Supplemental O2 Therapy: A Prospective Controlled Nonrandomized Study.


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:
24 08 2022
Historique:
received: 19 11 2021
pubmed: 28 1 2022
medline: 30 8 2022
entrez: 27 1 2022
Statut: ppublish

Résumé

Remdesivir is an antiviral used to treat coronavirus disease 2019 (COVID-19), which improves some clinical outcomes. Dexamethasone has been shown to be effective in reducing mortality. It has been hypothesized that combination of these two drugs can improve mortality. We evaluated the effect of combination on mortality of COVID-19 patients requiring O2 therapy. A prospective quasi-experimental study, including two independent, sequential controlled cohorts, one received remdesivir-dexamethasone and the other dexamethasone alone, was designed. All COVID-19 patients requiring supplemental O2 therapy were enrolled consecutively. The sample size to power mortality was a priori calculated. The primary endpoints were 30-day mortality and viral clearance differences. Secondary endpoints were differences in hospitalization times, improvement in respiratory failure (PO2/FiO2) and inflammatory indices (fibrinogen, CRP, neutrophil/lymphocyte ratio, D-Dimer). Kaplan-Meier curves and the log-rank test were used to evaluate significant differences in mortality between groups. In total, 151 COVID-19 patients were enrolled (remdesivir/dexamethasone group, 76, and dexamethasone alone, 75). No differences in demographic, clinical, and laboratory characteristics were observed between the 2 groups at baseline. Faster viral clearance occurred in the remdesivir/dexamethasone group compared to dexamethasone alone (median 6 vs 16 days; P < .001). The 30-day mortality in the remdesivir/dexamethasone group was 1.3%, whereas in dexamethasone alone was 16% (P < .005). In the remdesivir/dexamethasone group compared to dexamethasone alone there was a reduction in hospitalization days (P < .0001) and a faster improvement in both respiratory function and inflammatory markers. Remdesivir/dexamethasone treatment is associated with significant reduction in mortality, length of hospitalization, and faster SARS-CoV-2 clearance, compared to dexamethasone alone.

Sections du résumé

BACKGROUND
Remdesivir is an antiviral used to treat coronavirus disease 2019 (COVID-19), which improves some clinical outcomes. Dexamethasone has been shown to be effective in reducing mortality. It has been hypothesized that combination of these two drugs can improve mortality. We evaluated the effect of combination on mortality of COVID-19 patients requiring O2 therapy.
METHODS
A prospective quasi-experimental study, including two independent, sequential controlled cohorts, one received remdesivir-dexamethasone and the other dexamethasone alone, was designed. All COVID-19 patients requiring supplemental O2 therapy were enrolled consecutively. The sample size to power mortality was a priori calculated. The primary endpoints were 30-day mortality and viral clearance differences. Secondary endpoints were differences in hospitalization times, improvement in respiratory failure (PO2/FiO2) and inflammatory indices (fibrinogen, CRP, neutrophil/lymphocyte ratio, D-Dimer). Kaplan-Meier curves and the log-rank test were used to evaluate significant differences in mortality between groups.
RESULTS
In total, 151 COVID-19 patients were enrolled (remdesivir/dexamethasone group, 76, and dexamethasone alone, 75). No differences in demographic, clinical, and laboratory characteristics were observed between the 2 groups at baseline. Faster viral clearance occurred in the remdesivir/dexamethasone group compared to dexamethasone alone (median 6 vs 16 days; P < .001). The 30-day mortality in the remdesivir/dexamethasone group was 1.3%, whereas in dexamethasone alone was 16% (P < .005). In the remdesivir/dexamethasone group compared to dexamethasone alone there was a reduction in hospitalization days (P < .0001) and a faster improvement in both respiratory function and inflammatory markers.
CONCLUSIONS
Remdesivir/dexamethasone treatment is associated with significant reduction in mortality, length of hospitalization, and faster SARS-CoV-2 clearance, compared to dexamethasone alone.

Identifiants

pubmed: 35084022
pii: 6515763
doi: 10.1093/cid/ciac014
pmc: PMC8807307
doi:

Substances chimiques

Antiviral Agents 0
remdesivir 3QKI37EEHE
Adenosine Monophosphate 415SHH325A
Dexamethasone 7S5I7G3JQL
Alanine OF5P57N2ZX

Types de publication

Controlled Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e403-e409

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Aldo Marrone (A)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Riccardo Nevola (R)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Ausilia Sellitto (A)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Domenico Cozzolino (D)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Ciro Romano (C)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Giovanna Cuomo (G)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Concetta Aprea (C)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Michelangelo X Palou Schwartzbaum (MXP)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Carmen Ricozzi (C)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Simona Imbriani (S)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Luca Rinaldi (L)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Klodian Gjeloshi (K)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Andrea Padula (A)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Roberta Ranieri (R)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Carolina Ruosi (C)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Luciana Agnese Meo (LA)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Marianna Abitabile (M)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Francesca Cinone (F)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Caterina Carusone (C)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Luigi Elio Adinolfi (LE)

Internal Medicine COVID CENTER; Department of Advanced Medical and Surgery Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH