1. Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia
- Author
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Maliheh Khoramdad, Davood Khalili, Arash Mohazzab, Mohammad Javad Eslami, Mohammad Ali Zohal, Seyed Hassan Saadat, Mehdi Bagheri, Mostafa Ghanei, Mojtaba Varshochi, Shadi Ziaie, Mohammad Reza Heidari, Mohammad Memarian, Masoud Solaymani-Dodaran, Mansooreh Momen-Heravi, Maryam Haddadzadeh Shoushtari, Mohammad Hossein Afshari, Akram Ansarifar, Maryam Qaraati, Mohammad Mahdi Asadi, Mansoor Namazi, Reza Mosaed, Amir Hosein Ghazale, Ali Bakhtiari, Niusha Behzadseresht, Fatemeh Movasaghi, Raana Jafari-Moghaddam, Ahmad Reza Mobayen, Ramin Sami, Seyyed-Javad Hosseini-Shokouh, Akram Asghari, Samaneh Abbasian, Masoume Shahrokhi, Seyed Amin Setarehdan, Ensieh Vahedi, Abolfazl Mozafari, Javad Moazen, Masoud Nazemieh, Ali Qazvini, Javad Khodadadi, Nafiseh Rastgoo, Saeid Kalantari, Hossein Biganeh, Ali Taheri, and Zeynab Yassin
- Subjects
Male ,0301 basic medicine ,Kaplan-Meier Estimate ,Severity of Illness Index ,Lopinavir ,0302 clinical medicine ,immune system diseases ,Immunology and Allergy ,Aged, 80 and over ,virus diseases ,Covid19 ,Middle Aged ,Clinical trial ,Treatment Outcome ,Pyrazines ,030220 oncology & carcinogenesis ,Anesthesia ,Drug Therapy, Combination ,Female ,Hydroxychloroquine ,medicine.drug ,Moderate to severe ,Adult ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Adolescent ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Immunology ,Favipiravir ,Antiviral Agents ,Article ,Young Adult ,03 medical and health sciences ,Severity of illness ,medicine ,Humans ,Aged ,Pharmacology ,Ritonavir ,SARS-CoV-2 ,business.industry ,COVID-19 ,Length of Stay ,medicine.disease ,Virology ,Amides ,COVID-19 Drug Treatment ,Discontinuation ,Oxygen ,Regimen ,Pneumonia ,030104 developmental biology ,Intubation ,business - 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 (1 9 3) and Lopinavir/Ritonavir (1 8 7) 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.
- Published
- 2021