Favipiravir for COVID-19: real-time analysis of all 15 studies

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4/29	Late	Aghajani et al., Journal of Medical Virology, doi:10.1002/jmv.27053 (Peer Reviewed)	death, ↓26.1%, p=0.28	Decreased In-Hospital Mortality Associated with Aspirin Administration in Hospitalized Patients Due to Severe COVID-19
	Retrospective 991 hospitalized patients in Iran focusing on aspirin use but also showing results for HCQ, remdesivir, and favipiravir.
4/29	Details Source PDF Late treatment study Late treatment study
	Aghajani et al., Journal of Medical Virology, doi:10.1002/jmv.27053 (Peer Reviewed)
	Decreased In-Hospital Mortality Associated with Aspirin Administration in Hospitalized Patients Due to Severe COVID-19
	Retrospective 991 hospitalized patients in Iran focusing on aspirin use but also showing results for HCQ, remdesivir, and favipiravir. risk of death, 26.1% lower, RR 0.74, p = 0.28, treatment 40, control 951, univariate Cox proportional regression. Aghajani et al., 4/29/2021, retrospective, Iran, Middle East, peer-reviewed, 7 authors.
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4/21	Late	Zhao et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107702 (Peer Reviewed)	viral+, ↓59.0%, p=0.06	Favipiravir in the treatment of patients with SARS-CoV-2 RNA recurrent positive after discharge: a multicenter, open-label, randomized trial
	RCT with 55 patients (36 favipiravir, 19 control) who were PCR+ after recovery, showing improved viral clearance with treatment.
4/21	Details Source PDF Late treatment study Late treatment study
	Zhao et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107702 (Peer Reviewed)
	Favipiravir in the treatment of patients with SARS-CoV-2 RNA recurrent positive after discharge: a multicenter, open-label, randomized trial
	RCT with 55 patients (36 favipiravir, 19 control) who were PCR+ after recovery, showing improved viral clearance with treatment. risk of no virological cure, 59.0% lower, RR 0.41, p = 0.06, treatment 7 of 36 (19.4%), control 9 of 19 (47.4%). time to viral-, 52.4% lower, relative time 0.48, p = 0.04, treatment 36, control 19. Zhao et al., 4/21/2021, Randomized Controlled Trial, China, Asia, peer-reviewed, 25 authors.
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4/19	Late	Favipiravir Observational Study Group, Fujita Health University (Preprint)		Favipiravir Observational Study Interim Report 3
	Retrospective analysis of favipiravir use in 10,986 hospitalized patients, including analysis of changes in clinical status and side effects. Common adverse events were uric acid level increase and liver function enzyme increase. Authors ..
4/19	Details Source PDF Late treatment study Late treatment study
	Favipiravir Observational Study Group, Fujita Health University (Preprint)
	Favipiravir Observational Study Interim Report 3
	Retrospective analysis of favipiravir use in 10,986 hospitalized patients, including analysis of changes in clinical status and side effects. Common adverse events were uric acid level increase and liver function enzyme increase. Authors note that early embryonic lethality and teratogenicity due to favipiravir have been observed in animal models, that pregnant women must be excluded, and that all patients and partners should practice effective contraception. Favipiravir Observational Study Group et al., 4/19/2021, preprint, 1 author.
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4/17	Early	Fujii et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2021.04.013 (Peer Reviewed)		Early favipiravir treatment was associated with early defervescence in non-severe COVID-19 patients
	Retrospective 41 favipiravir patients finding that early treatment was more successful.
4/17	Details Source PDF Early treatment study Early treatment study
	Fujii et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2021.04.013 (Peer Reviewed)
	Early favipiravir treatment was associated with early defervescence in non-severe COVID-19 patients
	Retrospective 41 favipiravir patients finding that early treatment was more successful. Fujii et al., 4/17/2021, peer-reviewed, 10 authors.
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3/11	Late	Solaymani-Dodaran et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107522 (Peer Reviewed)	death, ↑19.2%, p=0.54	Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia
	RCT late stage patients (median SpO₂ 89), 193 treated with favipiravir, 187 with lopinavir/ritonavir, showing no significant differences in mortality, intubation, or ICU admission.
3/11	Details Source PDF Late treatment study Late treatment study
	Solaymani-Dodaran et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107522 (Peer Reviewed)
	Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia
	RCT late stage patients (median SpO₂ 89), 193 treated with favipiravir, 187 with lopinavir/ritonavir, showing no significant differences in mortality, intubation, or ICU admission. risk of death, 19.2% higher, RR 1.19, p = 0.54, treatment 26 of 190 (13.7%), control 21 of 183 (11.5%). risk of mechanical ventilation, 53.0% higher, RR 1.53, p = 0.15, treatment 27 of 190 (14.2%), control 17 of 183 (9.3%). risk of ICU admission, 19.4% higher, RR 1.19, p = 0.56, treatment 31 of 190 (16.3%), control 25 of 183 (13.7%). Solaymani-Dodaran et al., 3/11/2021, Randomized Controlled Trial, Iran, Middle East, peer-reviewed, 44 authors, this trial compares with another treatment - results may be better when compared to placebo.
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3/8	Late	Fateh et al., medRxiv, doi:10.1101/2021.03.05.21251351 (Preprint)		A single-center retrospective cohort study of Covid-19 medications: Remdesivir, Favipiravir, Methylprednisolone, Dexamethasone, and Interferon β1a and their combinations
	Retrospective 324 hospitalized patients in Iran reporting on the use Remdesivir, Favipiravir, Methylprednisolone, Dexamethasone, and Interferon β1a and their combinations. There is no control group in this study.
3/8	Details Source PDF Late treatment study Late treatment study
	Fateh et al., medRxiv, doi:10.1101/2021.03.05.21251351 (Preprint)
	A single-center retrospective cohort study of Covid-19 medications: Remdesivir, Favipiravir, Methylprednisolone, Dexamethasone, and Interferon β1a and their combinations
	Retrospective 324 hospitalized patients in Iran reporting on the use Remdesivir, Favipiravir, Methylprednisolone, Dexamethasone, and Interferon β1a and their combinations. There is no control group in this study. Fateh et al., 3/8/2021, retrospective, Iran, Middle East, preprint, 7 authors.
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2/4	Early, Late	Uçan et al., Research Square, doi:10.21203/rs.3.rs-175340/v1 (Preprint)		Benefits of Treatment With Favipiravir in Hospitalized Patients for COVID-19: a Retrospective Observational Case-control Study
	Retrospective 144 COVID-19 patients in Turkey, one group receiving FPV after a mean of 4.7 days, a second group after a mean of 8.6 days, and all groups receiving HCQ. No improvement in clinical outcomes was seen with the addition of FPV,..
2/4	Details Source PDF Early, Late Early, Late
	Uçan et al., Research Square, doi:10.21203/rs.3.rs-175340/v1 (Preprint)
	Benefits of Treatment With Favipiravir in Hospitalized Patients for COVID-19: a Retrospective Observational Case-control Study
	Retrospective 144 COVID-19 patients in Turkey, one group receiving FPV after a mean of 4.7 days, a second group after a mean of 8.6 days, and all groups receiving HCQ. No improvement in clinical outcomes was seen with the addition of FPV, however the groups are not comparable and no adjustments were made. FPV was first used in patients whose clinical condition worsened or whose pneumonia findings progressed, while later patients started FPV treatment early. Uçan et al., 2/4/2021, retrospective, Turkey, Middle East, preprint, 8 authors.
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1/25	Early	Dabbous et al., Archives of Virology, doi:10.1007/s00705-021-04956-9 (Peer Reviewed)	death, ↓45.5%, p=0.12	Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study
	RCT with 44 favipiravir patients and 48 CQ patients, showing non-statistically significant lower mortality, ventilation, and hospitalization time with favipiravir.
1/25	Details Source PDF Early treatment study Early treatment study
	Dabbous et al., Archives of Virology, doi:10.1007/s00705-021-04956-9 (Peer Reviewed)
	Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study
	RCT with 44 favipiravir patients and 48 CQ patients, showing non-statistically significant lower mortality, ventilation, and hospitalization time with favipiravir. risk of death, 45.5% lower, RR 0.55, p = 0.12, treatment 1 of 44 (2.3%), control 2 of 48 (4.2%). risk of mechanical ventilation, 88.5% lower, RR 0.12, p = 1.00, treatment 0 of 44 (0.0%), control 4 of 48 (8.3%), continuity correction due to zero event. hospitalization time, 16.4% lower, relative time 0.84, p = 0.06, treatment 44, control 48. Dabbous et al., 1/25/2021, Randomized Controlled Trial, Egypt, Middle East, peer-reviewed, 10 authors.
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1/14	Early	Karatas et al., Research Square, doi:10.21203/rs.3.rs-142868/v1 (Preprint)		Early Onset Favipiravir Saves Lives
	Retrospective 180 hospitalized patients showing lower mortality when Favipiravir is given earlier. 17% of patients given Favipiravir within 3 days died, compared to 38% when given after 3 days.
1/14	Details Source PDF Early treatment study Early treatment study
	Karatas et al., Research Square, doi:10.21203/rs.3.rs-142868/v1 (Preprint)
	Early Onset Favipiravir Saves Lives
	Retrospective 180 hospitalized patients showing lower mortality when Favipiravir is given earlier. 17% of patients given Favipiravir within 3 days died, compared to 38% when given after 3 days. Karatas et al., 1/14/2021, preprint, 5 authors.
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11/16	Early	Udwadia et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.11.142 (Peer Reviewed)	recov. time, ↓40.0%, p=0.03	Efficacy and Safety of Favipiravir, an Oral RNA-Dependent RNA Polymerase Inhibitor, in Mild-to-Moderate COVID-19: A Randomized, Comparative, Open-Label, Multicenter, Phase 3 Clinical Trial
	RCT with 75 favipiravir patients and 75 control patients showing reduced time to clinical cure and reduced time of viral shedding.
11/16	Details Source PDF Early treatment study Early treatment study
	Udwadia et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.11.142 (Peer Reviewed)
	Efficacy and Safety of Favipiravir, an Oral RNA-Dependent RNA Polymerase Inhibitor, in Mild-to-Moderate COVID-19: A Randomized, Comparative, Open-Label, Multicenter, Phase 3 Clinical Trial
	RCT with 75 favipiravir patients and 75 control patients showing reduced time to clinical cure and reduced time of viral shedding. recovery time, 40.0% lower, relative time 0.60, p = 0.03, treatment 75, control 75. time to viral-, 29.0% lower, relative time 0.71, p = 0.13, treatment 75, control 75. Udwadia et al., 11/16/2020, Randomized Controlled Trial, India, South Asia, peer-reviewed, 11 authors.
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11/9	Late	Khamis et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.11.008 (Peer Reviewed)		Randomized Controlled Open Label Trial on the Use of Favipiravir Combined with Inhaled Interferon beta-1b in Hospitalized Patients with Moderate to Severe COVID-19 Pneumonia
	Small 89 patient RCT comparing favipiravir and inhaled interferon with HCQ for moderate to severe COVID-19 pneumonia, not finding significant differences. There was no control group.
11/9	Details Source PDF Late treatment study Late treatment study
	Khamis et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.11.008 (Peer Reviewed)
	Randomized Controlled Open Label Trial on the Use of Favipiravir Combined with Inhaled Interferon beta-1b in Hospitalized Patients with Moderate to Severe COVID-19 Pneumonia
	Small 89 patient RCT comparing favipiravir and inhaled interferon with HCQ for moderate to severe COVID-19 pneumonia, not finding significant differences. There was no control group. Khamis et al., 11/9/2020, peer-reviewed, 11 authors.
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11/5	Late	Pushkar et al., NCT04542694 (Preprint)	no recov., ↓14.1%, p=0.06	Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
	RCT 200 patients showing improvements in clinical recovery and viral clearance with favipiravir. There is no paper available but results are posted in clinicaltrials.gov.
11/5	Details Source PDF Late treatment study Late treatment study
	Pushkar et al., NCT04542694 (Preprint)
	Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
	RCT 200 patients showing improvements in clinical recovery and viral clearance with favipiravir. There is no paper available but results are posted in clinicaltrials.gov. risk of no clinical status improvement of 2+ WHO-OSCI at ~10 days, 14.1% lower, RR 0.86, p = 0.06, treatment 73 of 100 (73.0%), control 85 of 100 (85.0%). relative time to clinical improvement, 33.3% lower, relative time 0.67, p < 0.001, treatment 100, control 100. risk of no fever reduction by day 3, 45.2% lower, RR 0.55, p < 0.001, treatment 40 of 100 (40.0%), control 73 of 100 (73.0%). relative time to resolution of fever, 20.0% lower, relative time 0.80, p = 0.05, treatment 100, control 100. risk of no discharge at day 10, 69.7% lower, RR 0.30, p < 0.001, treatment 10 of 100 (10.0%), control 33 of 100 (33.0%). risk of no full recovery at day 10, 26.7% lower, RR 0.73, p < 0.001, treatment 66 of 100 (66.0%), control 90 of 100 (90.0%). risk of no improvement in lung CT, 33.3% lower, RR 0.67, p = 0.007, treatment 40 of 100 (40.0%), control 60 of 100 (60.0%). risk of no virological cure, 90.5% lower, RR 0.10, p < 0.001, treatment 2 of 100 (2.0%), control 21 of 100 (21.0%). Pushkar et al., 11/5/2020, Randomized Controlled Trial, Russia, Asia, preprint, mean age 50.0, 1 author.
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10/26	Early	Ruzhentsova et al., SSRN, doi:10.2139/ssrn.3696907 (Preprint)	hosp., ↓6.0%, p=0.49	Phase 3 Trial of Coronavir (Favipiravir) in Patients with Mild to Moderate COVID-19
	RCT 168 patients, 112 receiving favipiravir and 56 SOC, showing shorter time to clinical improvement and faster viral clearance with favipiravir.
10/26	Details Source PDF Early treatment study Early treatment study
	Ruzhentsova et al., SSRN, doi:10.2139/ssrn.3696907 (Preprint)
	Phase 3 Trial of Coronavir (Favipiravir) in Patients with Mild to Moderate COVID-19
	RCT 168 patients, 112 receiving favipiravir and 56 SOC, showing shorter time to clinical improvement and faster viral clearance with favipiravir. risk of hospitalization, 6.0% lower, RR 0.94, p = 0.49, treatment 3 of 112 (2.7%), control 2 of 56 (3.6%), adjusted. risk of mechanical ventilation, 150.0% higher, RR 2.50, p = 1.00, treatment 1 of 112 (0.9%), control 0 of 56 (0.0%), continuity correction due to zero event. risk of ICU admission, 51.0% higher, RR 1.51, p = 0.63, treatment 3 of 112 (2.7%), control 1 of 56 (1.8%), adjusted. hazard ratio for time to clinical improvement, 38.7% lower, RR 0.61, p = 0.007, treatment 112, control 56. risk of no virological cure, 21.9% lower, RR 0.78, p = 0.16, treatment 112, control 56, day 5 mid-recovery. Ruzhentsova et al., 10/26/2020, Randomized Controlled Trial, Russia, Asia, preprint, 31 authors.
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8/9	Late	Ivashchenko et al., Clin. Infect. Dis., doi:10.1093/cid/ciaa1176 (Peer Reviewed)	viral+, ↓46.4%, p=0.03	AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter Randomized Clinical Trial
	Intermin results for a small RCT with 40 favipiravir and 20 control patients showing faster viral clearance with favipiravir. There is limited data in this report to evaluate the results. The report indicates that 75% of the control group..
8/9	Details Source PDF Late treatment study Late treatment study
	Ivashchenko et al., Clin. Infect. Dis., doi:10.1093/cid/ciaa1176 (Peer Reviewed)
	AVIFAVIR for Treatment of Patients with Moderate COVID-19: Interim Results of a Phase II/III Multicenter Randomized Clinical Trial
	Intermin results for a small RCT with 40 favipiravir and 20 control patients showing faster viral clearance with favipiravir. There is limited data in this report to evaluate the results. The report indicates that 75% of the control group received HCQ/CQ. risk of no virological cure, 46.4% lower, RR 0.54, p = 0.03, treatment 15 of 40 (37.5%), control 14 of 20 (70.0%), mid-recovery day 5. risk of no virological cure, 62.5% lower, RR 0.37, p = 0.21, treatment 3 of 40 (7.5%), control 4 of 20 (20.0%), day 10. risk of no discharge and WHO-OSC>2, 66.7% higher, RR 1.67, p = 0.51, treatment 10 of 40 (25.0%), control 3 of 20 (15.0%). risk of hospitalization, 300.0% higher, RR 4.00, p = 0.55, treatment 2 of 40 (5.0%), control 0 of 20 (0.0%), continuity correction due to zero event, 1600/600mg. Ivashchenko et al., 8/9/2020, Randomized Controlled Trial, Russia, Asia, peer-reviewed, 21 authors.
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3/18	Late	Cai et al., Engineering, doi:10.1016/j.eng.2020.03.007 (Peer Reviewed)	pneumonia, ↓68.7%, p=0.04	Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study
	Comparison of 35 FPV patients and 35 LPV/RTV patients, showing significant improvements in chest CT and faster viral clearance with FPV.
3/18	Details Source PDF Late treatment study Late treatment study
	Cai et al., Engineering, doi:10.1016/j.eng.2020.03.007 (Peer Reviewed)
	Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study
	Comparison of 35 FPV patients and 35 LPV/RTV patients, showing significant improvements in chest CT and faster viral clearance with FPV. risk of no improvement in CT, 68.7% lower, RR 0.31, p = 0.04, treatment 35, control 45, multivariate. risk of no virological cure, 70.9% lower, RR 0.29, p = 0.03, treatment 35, control 45, multivariate. Cai et al., 3/18/2020, retrospective, China, Asia, peer-reviewed, 26 authors.
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