Antiviral Agents Against COVID-19 Infection

Summary

A key strategy in the treatment of COVID-19 would be to find an effective antiviral agent that would decrease the peak viral load and, consequently, the associated degree of immunopathological damage that follows this phase. The clinically approved substances considered for this study are used for treatment of other virus diseases, like HIV (atazanavir) and HCV (sofosbuvir and daclatasvir). Severe progression of COVID-19 among patients under treatment for these aforementioned viruses is empirical less common. Besides, the clinical rationale, there are pre-clinical evidence pointing out that patients with COVID-19 could benefit from treatments with atazanavir, sofosbuvir and daclatasvir.

Timeline

Start

2021-02-15

Primary completion

2021-08-04

Completion

2021-08-04

Outcome

Missed primary endpoint

paper 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 PMID 36908503 ↗

Publications

• Maia IS, Marcadenti A, Veiga VC, Miranda TA, Gomes SPC, Carollo MBS, Negrelli KL, Gomes JO, Tramujas L, Abreu-Silva EO, Westphal GA, Fernandes RP, Horta JGA, Oliveira DC, Flato UAP, Paoliello RCR, Fernandes C, Zandonai CL, Coelho JC, Barros WC, Lemos JC, Bolan RS, Dutra MM, Gebara OCE, Lopes ATA, Alencar Filho MS, Arraes JA, Hamamoto VA, Hernandes ME, Golin NA, Santos TM, Santos RHN, Damiani LP, Zampieri FG, Gesto J, Machado FR, Rosa RG, Azevedo LCP, Avezum A, Lopes RD, Souza TML, Berwanger O, Cavalcanti AB; BRICNet. 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. Lancet Reg Health Am. 2023 Apr;20:100466. doi: 10.1016/j.lana.2023.100466. Epub 2023 Mar 8.
• Maia IS, Marcadenti A, Zampieri FG, Damiani LP, Santos RHN, Negrelli KL, Gomes SPDC, Gomes JO, Carollo MBDS, Miranda TA, Santucci E, Valeis N, Laranjeira LN, Westphal GA, Horta JGA, Flato UAP, Fernandes C, Barros WC, Bolan RS, Gebara OCE, Alencar Filho MS, Hamamoto VA, Hernandes ME, Golin NA, Olinda RT, Machado FR, Rosa RG, Veiga VC, Azevedo LCP, Avezum A, Lopes RD, Souza TML, Berwanger O, Cavalcanti AB. 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 Jan-Mar;34(1):44-55. doi: 10.5935/0103-507X.20220002-pt.

Drugs

Indications