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Efficacy of Favipiravir in the Treatment of Moderate COVID-19 Patients: A Randomized, Open-label, Controlled Clinical Trial

Tehrani et al., Mediterranean Journal of Infection Microbes and Antimicrobials, doi:10.4274/mjima.galenos.2022.2022.30, IRCT20211004052664N1
Jun 2022  
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Hospitalization 34% Improvement Relative Risk Recovery, day 7, dyspnea 80% Recovery, day 5, dyspnea 58% Recovery, day 7, fever 47% Recovery, day 5, fever 47% Recovery, day 7, sore throat 66% Recovery, day 5, sore throat 47% Recovery, day 7, cough 30% Recovery, day 5, cough 7% Recovery, day 7, myalgia 21% Recovery, day 5, myalgia 38% Favipiravir  Tehrani et al.  LATE TREATMENT  RCT Is late treatment with favipiravir beneficial for COVID-19? RCT 78 patients in Iran (April - September 2021) Lower hospitalization (p=0.24) and improved recovery (p=0.49), not sig. c19early.org Tehrani et al., Mediterranean J. Infec.., Jun 2022 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
RCT 78 patients in Iran, showing improved recovery with favipiravir treatment.
Potential risks of favipiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-5.
risk of hospitalization, 34.2% lower, RR 0.66, p = 0.24, treatment 10 of 38 (26.3%), control 16 of 40 (40.0%), NNT 7.3.
risk of no recovery, 79.6% lower, RR 0.20, p = 0.49, treatment 0 of 38 (0.0%), control 2 of 40 (5.0%), NNT 20, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7, dyspnea.
risk of no recovery, 57.9% lower, RR 0.42, p = 0.010, treatment 8 of 38 (21.1%), control 20 of 40 (50.0%), NNT 3.5, day 5, dyspnea.
risk of no recovery, 47.4% lower, RR 0.53, p = 1.00, treatment 1 of 38 (2.6%), control 2 of 40 (5.0%), NNT 42, day 7, fever.
risk of no recovery, 47.4% lower, RR 0.53, p = 0.25, treatment 5 of 38 (13.2%), control 10 of 40 (25.0%), NNT 8.4, day 5, fever.
risk of no recovery, 66.1% lower, RR 0.34, p = 1.00, treatment 0 of 38 (0.0%), control 1 of 40 (2.5%), NNT 40, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7, sore throat.
risk of no recovery, 47.4% lower, RR 0.53, p = 0.68, treatment 2 of 38 (5.3%), control 4 of 40 (10.0%), NNT 21, day 5, sore throat.
risk of no recovery, 29.8% lower, RR 0.70, p = 0.17, treatment 16 of 38 (42.1%), control 24 of 40 (60.0%), NNT 5.6, day 7, cough.
risk of no recovery, 7.1% lower, RR 0.93, p = 0.56, treatment 30 of 38 (78.9%), control 34 of 40 (85.0%), NNT 17, day 5, cough.
risk of no recovery, 21.1% lower, RR 0.79, p = 0.77, treatment 6 of 38 (15.8%), control 8 of 40 (20.0%), NNT 24, day 7, myalgia.
risk of no recovery, 38.1% lower, RR 0.62, p = 0.16, treatment 10 of 38 (26.3%), control 17 of 40 (42.5%), NNT 6.2, day 5, myalgia.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tehrani et al., 15 Jun 2022, Randomized Controlled Trial, Iran, peer-reviewed, mean age 52.5, 5 authors, study period April 2021 - September 2021, average treatment delay 5.29 days, trial IRCT20211004052664N1. Contact: amirrezakeyvanfar@yahoo.com.
This PaperFavipiravirAll
Efficacy of Favipiravir in the Treatment of Moderate COVID-19 Patients: A Randomized, Open-label, Controlled Clinical Trial
Shabnam Tehrani, Davood Yadegarynia, Afshin Bagherzade, Latif Gachkar, Amirreza Keyvanfar
Mediterranean Journal of Infection Microbes and Antimicrobials, doi:10.4274/mjima.galenos.2022.2022.30
Since the beginning of the Coronavirus disease-2019 (COVID-19) pandemic, scientists have studied many drugs to treat it, but none of them have been approved as a complete cure. Favipiravir is one of those drugs that effectively clears the body from the virus by interfering with the process of replication. This study aimed to determine the efficacy of favipiravir compared with supportive medication to treat moderate COVID-19 patients. Materials and Methods: In this randomized, open-label, controlled clinical trial, we examined the efficacy of favipiravir to treat moderate COVID-19 patients. The study was conducted in Labbafinejad Hospital (Tehran, Iran) from April to September 2021. A 1:1 ratio of eligible patients were assigned to the intervention and control groups. The control group received supportive medication. In addition to supportive medication, the intervention group received favipiravir. The primary endpoint was the hospitalization rate during the seven-day follow-up. And the secondary endpoints were symptoms, signs, and laboratory tests of the patients. Results: Out of 78 patients who were included in the study, 40 patients were assigned to the control group and 38 patients were assigned to the intervention group. At the beginning of treatment, the respiratory rate was higher in the intervention group (p=0.001), however, on the fifth (p=0.001) and seventh (p<0.001) days, it was significantly lower in the intervention group. In addition, oxygen saturation at the beginning of treatment was lower in the intervention group (p<0.001); however, on the fifth (p=0.016) and seventh (p<0.001) days, it was significantly higher in the intervention group. Furthermore, the consumption of favipiravir was not associated with the hospitalization rate (p=0.200). Conclusion: Favipiravir enhances respiratory manifestations in patients with moderate COVID-19 when compared to supportive medication alone.
Ethics Ethics Committee Approval: The Ethics Committee of the School of Medicine, of Shahid Beheshti University of Medical Sciences, approved this study on March 3, 2021 (approval ID: IR.SBMU.MSP.REC.1399.750). Informed Consent: Consent form was filled out by all participants. Peer-review: Externally peer-reviewed. Financial Disclosure: The authors declared that this study received no financial support. Authorship Contributions Concept
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Late treatment
is less effective
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