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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.
  • Solaymani-Dodaran M; Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; Division of Epidemiology and Public Health, University of Nottingham, Nottingham, NG7 2UH, UK; School of Public Health, Iran University of Medical Science, Tehran, Iran.
  • Ghanei M; Chemical Injuries Center, Systems Biology and Poisoning Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: mghaneister@gmail.com.
  • Bagheri M; Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Qazvini A; Trauma Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Vahedi E; Chemical Injuries Research Center, Systems Biology and Poisoning Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Hassan Saadat S; Behavioral sciences research center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Amin Setarehdan S; Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; School of Public Health, Iran University of Medical Science, Tehran, Iran.
  • Ansarifar A; School of Public Health, Iran University of Medical Science, Tehran, Iran.
  • Biganeh H; Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Mohazzab A; School of Public Health, Iran University of Medical Science, Tehran, Iran; Reproductive Biotechnology Research Center, Avicenna Research Institute Tehran, ACECR, Tehran, Iran.
  • Khalili D; Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Hosein Ghazale A; Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Reza Heidari M; Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Taheri A; Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Khoramdad M; School of Public Health, Iran University of Medical Science, Tehran, Iran.
  • Mahdi Asadi M; Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
  • Nazemieh M; Tuberculosis and Lung Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.
  • Varshochi M; Infectious and Tropical Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.
  • Abbasian S; Liver and Gastrointestinal Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.
  • Bakhtiari A; School of Medicine, Dezful University of Medical Science, Dezful, Iran.
  • Mosaed R; Faculty of Medicine, Aja University of Medical Science, Tehran, Iran.
  • Hosseini-Shokouh SJ; Infectious Disease Research Center, Faculty of Medicine, Aja University of Medical Science, Tehran, Iran.
  • Shahrokhi M; School of Management, Tehran University, Tehran, Iran.
  • Yassin Z; Antimicrobial Resistance Research Center, Iran University of Medical Science, Tehran, Iran.
  • Ali Zohal M; Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.
  • Qaraati M; Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.
  • Rastgoo N; Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.
  • Sami R; Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.
  • Javad Eslami M; School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.
  • Asghari A; Department of Internal Medicine, School of Medicine, Qom University of Medical sciences, Qom, Iran.
  • Namazi M; Department of Cardiology, School of Medicine, Qom University of Medical sciences, Qom, Iran.
  • Ziaie S; Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran.
  • Jafari-Moghaddam R; Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran.
  • Kalantari S; Antimicrobial Resistance Research Center, Iran University of Medical Science, Tehran, Iran.
  • Memarian M; Department of Internal Medicine, School of Medicine, Semnan University of Medical sciences, Semnan, Iran.
  • Khodadadi J; Department of Infectious disease, School of Medicine, Qom University of Medical sciences, Qom, Iran.
  • Hossein Afshari M; School of Medicine, Qom University of Medical sciences, Qom, Iran.
  • Momen-Heravi M; Infectious Diseases Research Center, School of Medicine, Kashan University of Medical Science, Kashan, Iran.
  • Behzadseresht N; School of Medicine, Kashan University of Medical Science, Kashan, Iran.
  • Reza Mobayen A; Department of Infectious disease, School of Medicine, Zanjan University of Medical sciences, Zanjan, Iran.
  • Mozafari A; Department of Medical sciences, Qom Branch, Islamic Azad University, Qom, Iran.
  • Movasaghi F; Department of Medical sciences, Qom Branch, Islamic Azad University, Qom, Iran.
  • Haddadzadeh Shoushtari M; Department of Infectious disease, School of Medicine, Ahvaz Jundishapur university of medical sciences, Ahvaz, Iran.
  • Moazen J; School of Medicine, Dezful University of Medical Science, Dezful, Iran.
Int Immunopharmacol ; 95: 107522, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1385749
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pyrazines / Amides / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Int Immunopharmacol Journal subject: Allergy and Immunology / Pharmacology Year: 2021 Document Type: Article Affiliation country: J.INTIMP.2021.107522

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pyrazines / Amides / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Int Immunopharmacol Journal subject: Allergy and Immunology / Pharmacology Year: 2021 Document Type: Article Affiliation country: J.INTIMP.2021.107522