Efficacy and safety of favipiravir plus interferon‐beta versus lopinavir/ritonavir plus interferon‐beta in moderately ill patients with COVID‐19: A randomized clinical trial
Mehdi Hassaniazad, Hossein Farshidi, Abdollah Gharibzadeh, Ali Bazram, Elham Khalili, Afsaneh Noormandi, Mohammad Fathalipour
Journal of Medical Virology, doi:10.1002/jmv.27724
Favipiravir (FVP), lopinavir/ritonavir (LPV/RTV), and interferon-beta (INF-beta) are considered as potential treatments for COVID-19. We examined the efficacy and safety of FVP and INF-beta compared to LPV/RTV and INF-beta combinations for the treatment of SARS-CoV-2. It was a single-center randomized clinical trial. Eligible patients were randomized to receive FVP plus INF-beta versus LPV/RTV plus INF-beta. The primary endpoint was the viral clearance after seven days of randomization. ICU admission, length of stay (LOS) in hospital, in-hospital mortality, and the incidence of adverse events were also measured. This trial was registered on the Iranian Registry of Clinical Trials (IRCT20200506047323N3). Patients were randomly allocated to the FVP (n = 33) and LPV/RTV (n = 33) groups. The viral clearance on Day seven was not significantly different between the FVP (31.1%) and the LPV/RTV groups (16.1%). The rate of ICU admission and likewise the in-hospital mortality in the FVP group (12.5% and 6.3%, respectively) were similar to the LPV/RTV groups (19.4% and 19.4%, respectively). The median LOS in the hospital was also not different (6.8 days [interquartile range; IQR = 5.0-11.0] in the FVP and (8.0 days [IQR = 5.5-12.5]) in LPV/RTV groups (p = 0.140). Adverse events were observed in 25.0% of FVP and 32.3% of LPV/RTV groups. The combination therapy with FVP did not exert a higher efficacy compared to the combination regimen of LPV/RTV. However, both treatment regimens demonstrated a mild profile of adverse events.
ACKNOWLEDGMENTS The authors appreciably thank the trial patients and their families, whose help and participation made this study possible. This study was financially supported by Hormozgan University of Medical Sciences (Grant no: 990233).
CONFLICTS OF INTEREST The authors declare no conflicts of interest.
SUPPORTING INFORMATION Additional supporting information may be found in the online version of the article at the publisher's website.
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