Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan - Critical Care Science (CCS)
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Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan
Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial.
Maia IS, Marcadenti A, Zampieri FG, Damiani LP, Santos RHN, Negrelli KL, Gomes SPC, et al. Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan. Rev Bras Ter Intensiva 2022;34(1):44-55.
Electronic Document Format (ABNT)
Maia, Israel Silva; Marcadenti, Aline; Zampieri, Fernando Godinho; Damiani, Lucas Petri; Santos, Renato Hideo Nakagawa; Negrelli, Karina Leal; Gomes, Samara Pinheiro do Carmo; Gomes, Jaqueline Oliveira; Carollo, Mariana Barbosa dos Santos; Miranda, Tamiris Abait; Santucci, Eliana; Valeis, Nanci; Laranjeira, Ligia Nasi; Westphal, Glauco Adrieno; Horta, Jacques Gabriel Alvares; Flato, Uri Adrian Prync; Fernandes, Camilo; Barros, Waldemar Carlos; Bolan, Renata S; Gebara, Otávio Celso Eluf; Alencar Filho, Meton Soares de; Hamamoto, Victor Augusto; Hernandes, Mauro Esteves; Golin, Nicole Alberti; Olinda, Ronald Torres de; Machado, Flávia Ribeiro; Rosa, Régis Goulart; Veiga, Viviane Cordeiro; Azevedo, Luciano César Pontes de; Avezum, Alvaro; Lopes, Renato Delascio; Souza, Tiago Moreno L; Berwanger, Otávio; Cavalcanti, Alexandre Biasi. Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan. Rev Bras Ter Intensiva, v. 34, n. 1, p. 44-55, Jun. 2022.
Electronic Document Format (APA)
Maia, I. S., Marcadenti, A., Zampieri, F. G., Damiani, L. P., Santos, R. H. N., Negrelli, K. L., Gomes, S. P. C., Gomes, J. O., Carollo, M. B. S., Miranda, T. A., Santucci, E., Valeis, N., Laranjeira, L. N., Westphal, G. A., Horta, J. G. A., Flato, U. A. P., Fernandes, C., Barros, W. C., Bolan, R. S., Gebara, O. C. E., Alencar Filho, M. S. , Hamamoto, V. A., Hernandes, M. E., Golin, N. A., Olinda, R. T. , Machado, F. R., Rosa, R. G., Veiga, V. C., Azevedo, L. C. P. , Avezum, A., Lopes, R. D., Souza, T. M. L., Berwanger, O., & Cavalcanti, A. B. (2022). Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan. Rev Bras Ter Intensiva, 34(1), 44-55.
Electronic Document Format (ISO)
Maia, Israel Silva and Marcadenti, Aline and Zampieri, Fernando Godinho and Damiani, Lucas Petri and Santos, Renato Hideo Nakagawa and Negrelli, Karina Leal and Gomes, Samara Pinheiro do Carmo and Gomes, Jaqueline Oliveira and Carollo, Mariana Barbosa dos Santos and Miranda, Tamiris Abait and Santucci, Eliana and Valeis, Nanci and Laranjeira, Ligia Nasi and Westphal, Glauco Adrieno and Horta, Jacques Gabriel Alvares and Flato, Uri Adrian Prync and Fernandes, Camilo and Barros, Waldemar Carlos and Bolan, Renata S and Gebara, Otávio Celso Eluf and Alencar Filho, Meton Soares de and Hamamoto, Victor Augusto and Hernandes, Mauro Esteves and Golin, Nicole Alberti and Olinda, Ronald Torres de and Machado, Flávia Ribeiro and Rosa, Régis Goulart and Veiga, Viviane Cordeiro and Azevedo, Luciano César Pontes de and Avezum, Alvaro and Lopes, Renato Delascio and Souza, Tiago Moreno L and Berwanger, Otávio and Cavalcanti, Alexandre Biasi. Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan. Rev Bras Ter Intensiva [online]. 2022, vol. 34, n. 1, [cited 2024-05-09], pp.44-55. Available from: <https://criticalcarescience.org/article/antivirals-for-adult-patients-hospitalized-with-sars-cov-2-infection-a-randomized-phase-ii-iii-multicenter-placebo-controlled-adaptive-study-with-multiple-arms-and-stages-coalition-covid-19-bra/>.
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Figura 1 | Fluxograma do estudo.
ATV - atazanavir; DCV - daclatasvir; SOF - sofosbuvir.
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