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

Solaymani-Dodaran et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107522
Mar 2021  
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Mortality -19% Improvement Relative Risk Ventilation -53% ICU admission -19% Favipiravir  Solaymani-Dodaran et al.  LATE TREATMENT  RCT Is late treatment with favipiravir beneficial for COVID-19? RCT 373 patients in Iran (February - March 2020) Trial compares with lopinavir/ritonavir, results vs. placebo may differ Higher mortality (p=0.54) and ventilation (p=0.15), not sig. c19early.org Solaymani-Dodaran et al., Int. Immunop.., Mar 2021 Favorsfavipiravir Favorslopinavir/ri.. 0 0.5 1 1.5 2+
RCT late stage patients (median SpO2 89), 193 treated with favipiravir, 187 with lopinavir/ritonavir, showing no significant differences in mortality, intubation, or ICU admission.
Potential risks of favipiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-5.
risk of death, 19.2% higher, RR 1.19, p = 0.54, treatment 26 of 190 (13.7%), control 21 of 183 (11.5%).
risk of mechanical ventilation, 53.0% higher, RR 1.53, p = 0.15, treatment 27 of 190 (14.2%), control 17 of 183 (9.3%).
risk of ICU admission, 19.4% higher, RR 1.19, p = 0.56, treatment 31 of 190 (16.3%), control 25 of 183 (13.7%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Solaymani-Dodaran et al., 11 Mar 2021, Randomized Controlled Trial, Iran, peer-reviewed, 44 authors, study period 4 February, 2020 - 8 March, 2020, this trial compares with another treatment - results may be better when compared to placebo.
This PaperFavipiravirAll
Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia
Masoud Solaymani-Dodaran, Mostafa Ghanei, Mehdi Bagheri, Ali Qazvini, Ensieh Vahedi, Seyed Hassan Saadat, Seyed Amin Setarehdan, Akram Ansarifar, Hossein Biganeh, Arash Mohazzab, Davood Khalili, Amir Hosein Ghazale, Mohammad Reza Heidari, Ali Taheri, Maliheh Khoramdad, Mohammad Mahdi Asadi, Masoud Nazemieh, Mojtaba Varshochi, Samaneh Abbasian, Ali Bakhtiari, Reza Mosaed, Seyyed-Javad Hosseini-Shokouh, Masoume Shahrokhi, Zeynab Yassin, Mohammad Ali Zohal, Maryam Qaraati, Nafiseh Rastgoo, Ramin Sami, Mohammad Javad Eslami, Akram Asghari, Mansoor Namazi, Shadi Ziaie, Raana Jafari-Moghaddam, Saeid Kalantari, Mohammad Memarian, Javad Khodadadi, Mohammad Hossein Afshari, Mansooreh Momen-Heravi, Niusha Behzadseresht, Ahmad Reza Mobayen, Abolfazl Mozafari, Fatemeh Movasaghi, Maryam Haddadzadeh Shoushtari, Javad Moazen
International Immunopharmacology, doi:10.1016/j.intimp.2021.107522
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 (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO 2 after 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 (1 9 3) and Lopinavir/Ritonavir (1 8 7) groups in 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 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.
Authors' contributionsRole of the funding source All authors drafted and drafted the manuscript, revised the manuscript, supervised the treatment and the and wrote the manuscript; and all authors approved the manuscript.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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