Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Jun:95:107522.
doi: 10.1016/j.intimp.2021.107522. Epub 2021 Mar 11.

Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia

Masoud Solaymani-Dodaran  1 , Mostafa Ghanei  2 , Mehdi Bagheri  3 , Ali Qazvini  4 , Ensieh Vahedi  5 , Seyed Hassan Saadat  6 , Seyed Amin Setarehdan  7 , Akram Ansarifar  8 , Hossein Biganeh  9 , Arash Mohazzab  10 , Davood Khalili  11 , Amir Hosein Ghazale  9 , Mohammad Reza Heidari  9 , Ali Taheri  9 , Maliheh Khoramdad  8 , Mohammad Mahdi Asadi  9 , Masoud Nazemieh  12 , Mojtaba Varshochi  13 , Samaneh Abbasian  14 , Ali Bakhtiari  15 , Reza Mosaed  16 , Seyyed-Javad Hosseini-Shokouh  17 , Masoume Shahrokhi  18 , Zeynab Yassin  19 , Mohammad Ali Zohal  20 , Maryam Qaraati  20 , Nafiseh Rastgoo  20 , Ramin Sami  21 , Mohammad Javad Eslami  22 , Akram Asghari  23 , Mansoor Namazi  24 , Shadi Ziaie  25 , Raana Jafari-Moghaddam  25 , Saeid Kalantari  19 , Mohammad Memarian  26 , Javad Khodadadi  27 , Mohammad Hossein Afshari  28 , Mansooreh Momen-Heravi  29 , Niusha Behzadseresht  30 , Ahmad Reza Mobayen  31 , Abolfazl Mozafari  32 , Fatemeh Movasaghi  32 , Maryam Haddadzadeh Shoushtari  33 , Javad Moazen  15
Affiliations
Randomized Controlled Trial

Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia

Masoud Solaymani-Dodaran et al. Int Immunopharmacol. 2021 Jun.

Abstract

Background: We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2.

Methods: We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO2) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO2 after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups.

Results: 380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO2 after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.

Keywords: Clinical trial; Covid19; Favipiravir; Hydroxychloroquine; Lopinavir; Ritonavir; SARS-CoV-2.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Participants flow diagram.
Fig. 2
Fig. 2
Kaplan Meier Failure plot showing time to clinical recovery by treatment groups in modified ITT population.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Venkatasubbaiah M., Dwarakanadha Reddy P., Satyanarayana S.V. Literature-based review of the drugs used for the treatment of COVID-19. Curr Med Res Pract. 2020;10(3):100–109. - PMC - PubMed
    1. Şimşek Yavuz S., Ünal S. Antiviral treatment of COVID-19. Turk. J Med Sci. 2020;50(SI-1):611–619. - PMC - PubMed
    1. Tuccori M., Convertino I., Ferraro S., et al. The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance. Drug Safety. 2020 - PMC - PubMed
    1. Furuta Y., Takahashi K., Fukuda Y., et al. In Vitro and In Vivo Activities of Anti-Influenza Virus Compound T-705. Antimicrobial Agents and Chemotherapy. 2002;46(4):977–981. - PMC - PubMed
    1. Furuta Y., Komeno T., Nakamura T. Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase. Proceedings of the Japan Academy Series B, Physical and biological sciences. 2017;93(7):449–463. - PMC - PubMed

Publication types

MeSH terms