Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.

Adenosine Monophosphate / analogs & derivatives Aged Alanine / analogs & derivatives Antiviral Agents / administration & dosage COVID-19 / mortality Drug Therapy, Combination Female Hospital Mortality Hospitalization Humans Hydroxychloroquine / therapeutic use Intention to Treat Analysis Interferon beta-1a / therapeutic use Kaplan-Meier Estimate Length of Stay Lopinavir / therapeutic use Male Middle Aged Respiration, Artificial Treatment Failure COVID-19 Drug Treatment

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
11 02 2021

Historique:

pubmed: 3 12 2020

medline: 13 2 2021

entrez: 2 12 2020

Statut: ppublish

Résumé

World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).

Sections du résumé

BACKGROUND

METHODS

We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.

RESULTS

At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.

CONCLUSIONS

These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).

Identifiants

DOI: 10.1056/NEJMoa2023184 PMID: 33264556 PMC: PMC7727327

pubmed: 33264556

doi: 10.1056/NEJMoa2023184

pmc: PMC7727327

doi:

Substances chimiques

Antiviral Agents 0

Lopinavir 2494G1JF75

remdesivir 3QKI37EEHE

Adenosine Monophosphate 415SHH325A

Hydroxychloroquine 4QWG6N8QKH

Alanine OF5P57N2ZX

Interferon beta-1a XRO4566Q4R

Banques de données

ISRCTN

['ISRCTN83971151']

ClinicalTrials.gov

['NCT04315948']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

497-511

Subventions

Organisme : World Health Organization

ID : 001

Pays : International

Organisme : NIAID NIH HHS

ID : U01 AI069476

Pays : United States

Organisme : NIAID NIH HHS

ID : UM1 AI069476

Pays : United States

Investigateurs

A Maggioni (A)

A Babiker (A)

D Cook (D)

A Dondorp (A)

G Kang (G)

S Trelle (S)

S McGinty (S)

M Branca (M)

S Appadoo (S)

J A C Sterne (JAC)

C A Rogers (CA)

H B C Cappel-Porter (HBC)

D Hutton (D)

S Bellani (S)

E Allum (E)

J Kirwan (J)

H Pan (H)

R Peto (R)

A M Henao-Restrepo (AM)

P Lydon (P)

M C Miranda-Montoya (MC)

M-P Preziosi (MP)

K K Salami (KK)

V Sathiyamoorthy (V)

S Swaminathan (S)

N Como (N)

N Sinani (N)

G Lopardo (G)

M Roses Periago (M)

E P Nunes (EP)

P P S Reges (PPS)

S Murthyt (S)

M Salvadori (M)

C A Alvarez-Moreno (CA)

M L Mesa Rubio (ML)

M Hassany (M)

H Zaid (H)

K A O Tikkinen (KAO)

M Perola (M)

F Ader (F)

M P Kieny (MP)

M T Medina (MT)

N Cerrato (N)

S Godbolet (S)

K S Reddy (KS)

I Irmansyah (I)

M R Rasmin (MR)

R Malekzadeh (R)

J Eustace (J)

P Lennon (P)

T Maguire (T)

E Tacconelli (E)

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A Alhasawi (A)

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P Abi Hanna (P)

R Hamra (R)

L Jancoriene (L)

L Griskevicius (L)

T S Chow (TS)

S Kumar (S)

M Stevanovikj (M)

S Manevska (S)

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A Barratt-Duet (A)

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A Raza (A)

M Hassan (M)

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