Dataset Information

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

ABSTRACT:

Background

Repurposed drugs for treatment of new onset disease may be an effective therapeutic shortcut. We aimed to evaluate the efficacy of repurposed antivirals compared to placebo in lowering SARS-CoV2 viral load of COVID-19 patients.

Methods

REVOLUTIOn is a randomised, parallel, blinded, multistage, superiority and placebo controlled randomised trial conducted in 35 centres in Brazil. We include patients aged 18 years or older admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, symptoms onset 9 days or less and SpO₂ 94% or lower at room air were eligible. All participants were randomly allocated to receive either atazanavir, daclatasvir or sofosbuvir/daclatasvir or placebo for 10 days. The primary outcome was the decay rate (slope) of the SARS-CoV-2 viral load logarithm assessed in the modified intention to-treat population. This trial was registered with ClinicalTrials.gov, number NCT04468087.

Findings

Between February 09, 2021, and August 04, 2021, 255 participants were enrolled and randomly assigned to atazanavir (n = 64), daclatasvir (n = 66), sofosbuvir/daclatasvir (n = 67) or placebo (n = 58). Compared to placebo group, the change from baseline to day 10 in log viral load was not significantly different for any of the treatment groups (0.05 [95% CI, -0.03 to 0.12], -0.02 [95% CI, -0.09 to 0.06], and -0.03 [95% CI, -0.11 to 0.04] for atazanavir, daclatasvir and sofosbuvir/daclatasvir groups respectively). There was no significant difference in the occurrence of serious adverse events between treatment groups.

Interpretation

No significant reduction in viral load was observed from the use of atazanavir, daclatasvir or sofosbuvir/daclatasvir compared to placebo in hospitalised COVID-19 patients who need oxygen support with symptoms onset 9 days or less.

Funding

Ministério da Ciência, Tecnologia e Inovação (MCTI) - Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ); Cia Latino-Americana de Medicamentos (Clamed); Cia Industrial H. Carlos Schneider (Ciser); Hospital Research Foundation Incorporation, Australia, HCor São Paulo; Blanver Farmoquímica; Instituto de Tecnologia em Fármacos (Farmanguinhos) da Fundação Oswaldo Cruz (Fiocruz); Coordenação Geral de Planejamento Estratégico (Cogeplan)/Fiocruz; and Fundação de apoio a Fiocruz (Fiotec, VPGDI-054-FIO-20-2-13).

SUBMITTER: Maia IS

PROVIDER: S-EPMC9991866 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

Maia Israel S IS Marcadenti Aline A Veiga Viviane C VC Miranda Tamiris A TA Gomes Samara P C SPC Carollo Mariana B S MBS Negrelli Karina L KL Gomes Jackeline O JO Tramujas Lucas L Abreu-Silva Erlon O EO Westphal Glauco A GA Fernandes Ruthy P RP Horta Jacques G A JGA Oliveira Deborah C DC Flato Uri A P UAP Paoliello Ricardo C R RCR Fernandes Camilo C Zandonai Cássio L CL Coelho Juliana C JC Barros Waldemar C WC Lemos Juliana C JC Bolan Renata S RS Dutra Marcela M MM Gebara Otavio C E OCE Lopes Ana T A ATA Alencar Filho Meton S MS Arraes Jussara A JA Hamamoto Victor A VA Hernandes Mauro E ME Golin Nicole A NA Santos Tiago M TM Santos Renato H N RHN Damiani Lucas P LP Zampieri Fernando G FG Gesto João J Machado Flávia R FR Rosa Régis G RG Azevedo Luciano C P LCP Avezum Alvaro A Lopes Renato D RD Souza Thiago M L TML Berwanger Otávio O Cavalcanti Alexandre B AB

Lancet regional health. Americas 20230308

<h4>Background</h4>Repurposed drugs for treatment of new onset disease may be an effective therapeutic shortcut. We aimed to evaluate the efficacy of repurposed antivirals compared to placebo in lowering SARS-CoV2 viral load of COVID-19 patients.<h4>Methods</h4>REVOLUTIOn is a randomised, parallel, blinded, multistage, superiority and placebo controlled randomised trial conducted in 35 centres in Brazil. We include patients aged 18 years or older admitted to hospital with laboratory-confirmed SA ...[more]

PMID: 36908503

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Dataset Information

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

Similar Datasets

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