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. 2020 Aug 3;13(9):1187–1195. doi: 10.1016/j.jiph.2020.07.013

Table 3.

Trials/studies involving Favipiravir.

Study type Trial outcome and design Conclusion Comments
Exploratory Randomized, Controlled Trial [26] 29 COVID-19 confirmed cases were randomized (1:1:1) to either receive Favipiravir for 14 days or Baloxavir Marboxil (80 mg once a day orally on Day 1 and Day 4) or control group. Findings do not support that adding either baloxavir or favipiravir under the trial dosages to the existing standard treatment benefit COVID-19 patients. Small sample size, non-blinded trial.
All patients received existing antiviral treatment including lopinavir/ritonavir (400 mg/100 mg, bid, orally) or darunavir/cobicistat (800 mg/150 mg, qd, orally) and arbidol (200 mg, tid, po.). Concurrent use of other antivirals leads to misinterpretation of results.
All of them used in combination with interferon-α inhalation.
On day 14, PCR was undetectable in all control group and 77% and 70 % in Baloxavir and Favipiravir groups, respectively.
Furthermore, there was no significant difference between all groups in clinical improvement.
One patient in the baloxavir marboxil group, and two patients in the favipiravir group transferred to ICU within seven days after trial initiation. Among all 29 patients, there was no death.
Prospective, randomized, controlled, open-label multicenter trial [27] 236 moderate/severe confirmed COVID-19 cases randomized; 116 to receive Favipiravir for 10 days and 120 to receive Umifenovir (Arbidol) for 10 days and all patients received conventional therapy. Favipiravir, compared to Arbidol, did not significantly improve the clinically recovery rate at Day 7. Favipiravir significantly improved the latency to relief for pyrexia and cough. Number of severe and critically ill patients were more in favipiravir that undermine the benefit of Arbidol.
Upon results, clinical improvement at day 7 (primary end point), did not significantly different between two groups. Whereas, in post-hoc analysis for moderate COVID-19 patients showed a significant higher clinical improvement in the Arbidol group (62/111, 55.86%) compared to Favipiravir group (70/98, 71.43%).
Favipiravir led to shorter latencies to relief for both pyrexia and cough. Whereas, no significant differences were found between both groups in the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV).
Case report [28] Two case reports with confirmed COVID-19. First case was young healthy male mild COVID-19 who received supportive care only and showed that supportive care alone with a tendency to gradually improve fever reduction and oxygenation and negative PCR found in day 20 of illness. Whereas, the second case showed 60 years old man with hypertension and diabetes mellitus admitted with severe case of COVID-19 received supportive care with Favipiravir. Since starting the drug, temperature decreased and improvement in oxygenation and dietary intake noted. In COVID-19 patient with hypoxemia, Favipiravir showed as promising effect. Whereas, in healthy young patients, spontaneous remission in illness was observed only with supportive care. Results based on two cases, larger studies needed to confirm these results.
Case report [29] 40 years old healthy female with severe COVID-19 received Ciclesonide and Favipiravir. Additionally, positive mycoplasma antigen was positive, thus levofloxacin started upon admission for 6 days. Upon follow up, fever and oxygenation didn’t worsen and improvement in chest Ct scan showed on day 6. Day 10 of hospitalization, patient discharged with improvement in symptoms and negative PCR. The administration of Favipiravir and ciclesonide in early onset was considered to be effective in improving symptoms. Results based on single case, larger studies needed to confirm these results.
An Open-Label Control Study [30] 80 confirmed mild to moderate severity cases of COVID-19 were assigned to receive either Favipiravir (n = 35) or Lopinavir /ritonavir (n = 55) (control group) for 14 days and both groups received interferon (IFN)-a by aerosol inhalation. FPV arm showed preferable outcomes compared to control arm, including shorter viral clearance (4 (2.5–9) d vs 11 (8–13) d, P < 0.001) and significant improvement in chest imaging (improvement rate of 91.43% vs 62.22%, P = 0.004). Favipiravir showed significantly better treatment effects on COVID-19 in terms of disease progression and viral clearance. Only mild to moderate cases were included in the study.