The Efficacy and Adverse Effects of Favipiravir on COVID-19 Patients: A&amp;nbsp;Systematic Review and Meta-Analysis of Published Clinical Trials and Observational Studies

Hung, Dang The; Ghula, Suhaib; Aziz, Jeza Abdul; Makram, Abdelrahman M; Tawfik, Gehad Mohamed; Abozaid, Ali Ahmed-Fouad; Pancharatnam, Rohan Andrew; Ibrahim, Amr Mohamed; Shabouk, Muhammad Besher; Turnage, Morgan; Nakhare, Saloni; Karmally, Zahra; Kouz, Basel; Le, Thuy; Alhijazeen, Suleiman; Phuong, Nguyen Quoc; Ads, Alaa Mohamed; Abdelaal, Ali Hussein; Nam, Nguyen Hai; Iiyama, Tatsuo; Kita, Koichi; Hirayama, Kenji; Huy, Nguyen Tien

doi:10.2139/ssrn.3889346

Cited by 2 publications

(1 citation statement)

References 131 publications

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“…A recent meta-analysis of 145 favipiravir studies on COVID-19 showed that favipiravir leads to a higher rate of viral clearance, defervescence, chest computed tomography (CT) improvement, and hospital discharge [ 11 ]. A more recent study of hospitalized patients was carried out in Japan [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

Finberg

Ashraf

Jülg

et al. 2021

Open Forum Infectious Diseases

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Background Favipiravir is used to treat influenza, and studies demonstrate that it has antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We performed a randomized, open-label, multicenter, phase 2 proof-of-concept trial of favipiravir in hospitalized adult patients with polymerase chain reaction (PCR)–positive coronavirus disease 2019 (COVID-19). Patients were randomized to standard of care (SOC) or favipiravir treatment (1800mg per os twice a day [b.i.d.] on day 1, followed by 1000mg b.i.d. for 13 days). The primary end point was time to viral clearance on day 29. Results Fifty patients were enrolled and stratified by disease severity (critical disease, severe disease, or mild to moderate disease). Nineteen patients were censored from the event of viral clearance based on being SARS-CoV-2 PCR-negative at the study outset, being PCR-positive at day 29, or because of loss to follow-up. Data from the 31 remaining patients who achieved viral clearance show enhanced viral clearance in the favipiravir group compared with the SOC group by day 29, with 72% of the favipiravir group and 52% of the SOC group being evaluable for viral clearance through day 29. The median time to viral clearance was 16.0 days (90% CI, 12.0 to 29.0) in the favipiravir group and 30.0 days (90% CI, 12.0 to 31.0) in the SOC group. A post hoc analysis revealed an effect in the subgroup of patients who were neutralizing antibody–negative at randomization. Treatment-emergent adverse events were equally distributed between the groups. Conclusions We demonstrate that favipiravir can be safely administered to hospitalized adults with COVID-19 and believe that further studies are warranted. ClinicalTrials.gov registration NCT04358549.

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Section: Discussionmentioning

confidence: 99%

US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

Finberg

Ashraf

Jülg

et al. 2021

Open Forum Infectious Diseases

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Pulmonary toxicity associated with high-dose favipiravir and treatment options: biochemical and histopathological evaluation.

Elma,

Suleyman,

Mammadov

et al. 2024

Investigación Clínica

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Favipiravir is a broad-spectrum antiviral drug that is a viral RNA-dependent RNA polymerase inhibitor. Favipiravir is used in high doses to treat COVID-19 but has a side effect on humans at high doses. The side effects of favipiravir have been associated with oxidative stress in the literature. In this trial, we investigated the biochemical and histopathological effects of lacidip-ine, thiamine pyrophosphate (TTP), and adenosine triphosphate (ATP), drugs with antioxidant properties, on the lung toxicity caused by high-dose favipiravir in rats. The rats were classified into five groups: healthy (HG), favipiravir alone (Fav), lacidipine+favipiravir (LFav), TPP+favipiravir (TFav), and ATP+favipiravir (AFav). Favipiravir (800 mg/kg) was administered twice daily for seven days. Laci-dipine (4 mg/kg), TPP (20 mg/kg), and ATP (25 mg/kg) were administered once daily for seven days. Oxidant (malondialdehyde), non-enzymatic (total glutathi-one), and enzymatic (superoxide dismutase and catalase) antioxidant levels were measured in the excised lung tissues. Furthermore, the tissues were histopatho-logically examined. The systemic administration of high doses of favipiravir in-creased oxidant levels and decreased antioxidant levels in the lung tissue of rats. In parallel, the histopathological examination of the lung tissue revealed the presence of severe mononuclear cell infiltrations in interstitial areas and pronounced lymphoid hyperplasia. Lacidipine exhibited superior efficacy in mit-igating oxidative stress and preventing the decline of antioxidants induced by favipiravir compared with TPP and ATP. Histopathologically, the lacidipine admin-istration significantly reduced lung oxidative damage. TTP moderately reduced severe favipiravir-associated lung injury. However, ATP was ineffective against fa-vipiravir-associated lung injury. Lacidipine offers more therapeutic benefits than TPP in treating oxidative lung injury caused by high doses of favipiravir.

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The Efficacy and Adverse Effects of Favipiravir on COVID-19 Patients: A Systematic Review and Meta-Analysis of Published Clinical Trials and Observational Studies

Cited by 2 publications

References 131 publications

US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

Pulmonary toxicity associated with high-dose favipiravir and treatment options: biochemical and histopathological evaluation.

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