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

• Published in: International immunopharmacology Vol. 95; p. 107522
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-06-2021; Elsevier BV
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Amides - administration & dosage; Amides - adverse effects; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Clinical trial; Computed tomography; COVID-19 Drug Treatment; Covid19; Drug Therapy, Combination; Favipiravir; Female; Humans; Hydroxychloroquine; Hydroxychloroquine - administration & dosage; Hydroxychloroquine - adverse effects; Intubation; Kaplan-Meier Estimate; Length of Stay; Lopinavir; Lopinavir - administration & dosage; Lopinavir - adverse effects; Male; Middle Aged; Mortality; Oxygen; Oxygen - blood; Oxygen content; Patient admissions; Patients; Pyrazines - administration & dosage; Pyrazines - adverse effects; Recovery; Ritonavir; Ritonavir - administration & dosage; Ritonavir - adverse effects; Safety; SARS-CoV-2; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Severity of Illness Index; Treatment Outcome; Young Adult; SARS-CoV-2; Hydroxychloroquine; Ritonavir; Covid19; Lopinavir; Favipiravir; Clinical trial
• ISSN: 1567-5769; 1878-1705
• DOI: 10.1016/j.intimp.2021.107522

•Favipiravir does not reduce number of ICU admissions or intubations or in-hospital mortality.•Favipiravir does not shorten time to clinical recovery and length of hospital stay.•We found no clinical benefit from a treatment regimen based on Favipiravir in SARS-CoV-2.
We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2.
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.
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)
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.