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

Solaymani-Dodaran, Masoud; Ghanei, Mostafa; Bagheri, Mehdi; Qazvini, Ali; Vahedi, Ensieh; Hassan Saadat, Seyed; Amin Setarehdan, Seyed; Ansarifar, Akram; Biganeh, Hossein; Mohazzab, Arash; Khalili, Davood; Hosein Ghazale, Amir; Reza Heidari, Mohammad; Taheri, Ali; Khoramdad, Maliheh; Mahdi Asadi, Mohammad; Nazemieh, Masoud; Varshochi, Mojtaba; Abbasian, Samaneh; Bakhtiari, Ali; Mosaed, Reza; Hosseini-shokouh, Seyyed-Javad; Shahrokhi, Masoume; Yassin, Zeynab; Ali Zohal, Mohammad; Qaraati, Maryam; Rastgoo, Nafiseh; Sami, Ramin; Javad Eslami, Mohammad; Asghari, Akram; Namazi, Mansoor; Ziaie, Shadi; Jafari-Moghaddam, Raana; Kalantari, Saeid; Memarian, Mohammad; Khodadadi, Javad; Hossein Afshari, Mohammad; Momen-Heravi, Mansooreh; Behzadseresht, Niusha; Reza Mobayen, Ahmad; Mozafari, Abolfazl; Movasaghi, Fatemeh; Haddadzadeh Shoushtari, Maryam; Moazen, Javad

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 (SpO(2)) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO(2) after 5 minutes 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 SpO(2) 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.