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Late |
Almoosa et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2021.08.022 (Peer Reviewed) |
death, ↑42.3%, p=0.10 |
Favipiravir versus Standard of Care in Patients with Severe COVID-19 Infections: A Retrospective Comparative Study |
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Retrospective 226 COVID-19 pneumonia patients, 110 treated with favipiravir, showing higher mortality (p=0.1) and ICU admission (p=0.02) with treatment in multivariate analysis. |
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Late treatment study
Late treatment study
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| Almoosa et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2021.08.022 (Peer Reviewed) |
| Favipiravir versus Standard of Care in Patients with Severe COVID-19 Infections: A Retrospective Comparative Study |
Retrospective 226 COVID-19 pneumonia patients, 110 treated with favipiravir, showing higher mortality (p=0.1) and ICU admission (p=0.02) with treatment in multivariate analysis.
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risk of death, 42.3% higher, RR 1.42, p = 0.10, treatment 33 of 110 (30.0%), control 24 of 116 (20.7%), adjusted, OR converted to RR, overall mortality, multivariate binary logistic regression.
risk of ICU admission, 90.0% higher, RR 1.90, p = 0.02, treatment 110, control 116, adjusted, multivariate binary logistic regression, RR approximated with OR.
recovery time, 10.9% higher, relative time 1.11, p = 0.17, treatment 110, control 116.
Almoosa et al., 8/24/2021, retrospective, Saudi Arabia, Middle East, peer-reviewed, 14 authors.
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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 |
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Retrospective 991 hospitalized patients in Iran focusing on aspirin use but also showing results for HCQ, remdesivir, and favipiravir. |
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Late treatment study
Late treatment study
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| 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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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 |
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RCT with 55 patients (36 favipiravir, 19 control) who were PCR+ after recovery, showing improved viral clearance with treatment. |
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Late treatment study
Late treatment study
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| 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.
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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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Late |
Favipiravir Observational Study Group, Fujita Health University (Preprint) |
Favipiravir Observational Study Interim Report 3 |
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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 .. |
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Late treatment study
Late treatment study
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| 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.
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Favipiravir Observational Study Group et al., 4/19/2021, preprint, 1 author.
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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 |
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Retrospective 41 favipiravir patients finding that early treatment was more successful. |
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Early treatment study
Early treatment study
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| 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.
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Fujii et al., 4/17/2021, peer-reviewed, 10 authors.
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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 |
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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. |
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Late treatment study
Late treatment study
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| 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.
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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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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 |
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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. |
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Late treatment study
Late treatment study
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| 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.
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Fateh et al., 3/8/2021, retrospective, Iran, Middle East, preprint, 7 authors.
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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 |
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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,.. |
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Early, Late
Early, Late
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| 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.
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Uçan et al., 2/4/2021, retrospective, Turkey, Europe, preprint, 8 authors.
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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 |
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RCT with 44 favipiravir patients and 48 CQ patients, showing non-statistically significant lower mortality, ventilation, and hospitalization time with favipiravir. |
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Early treatment study
Early treatment study
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| 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, Africa, peer-reviewed, 10 authors.
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Early |
Karatas et al., Research Square, doi:10.21203/rs.3.rs-142868/v1 (Preprint) |
Early Onset Favipiravir Saves Lives |
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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. |
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Early treatment study
Early treatment study
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| 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.
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Karatas et al., 1/14/2021, preprint, 5 authors.
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Late |
Doi et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/AAC.01897-20 (Peer Reviewed) |
A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19 |
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Small RCT comparing late and very late (7 and 14 days from fever onset) favipiravir. Viral clearance was non-statistically significantly improved with relatively early treatment. There was a reduction in time to defervescence, and a signi.. |
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Late treatment study
Late treatment study
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| Doi et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/AAC.01897-20 (Peer Reviewed) |
| A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19 |
Small RCT comparing late and very late (7 and 14 days from fever onset) favipiravir. Viral clearance was non-statistically significantly improved with relatively early treatment. There was a reduction in time to defervescence, and a significant improvement in fever was observed the day after starting therapy. There was no progression or mortality. While limited by the small sample size, authors conclude that the results suggest antiviral activity of favipiravir in this patient population. There was no control group.
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Doi et al., 11/17/2020, Randomized Controlled Trial, peer-reviewed, 45 authors.
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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 |
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RCT with 75 favipiravir patients and 75 control patients showing reduced time to clinical cure and reduced time of viral shedding. |
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Early treatment study
Early treatment study
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| 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.
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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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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 |
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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. |
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Late treatment study
Late treatment study
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| 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 |
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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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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 |
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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. |
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Late treatment study
Late treatment study
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| 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, Europe, preprint, mean age 50.0, 1 author.
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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 |
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RCT 168 patients, 112 receiving favipiravir and 56 SOC, showing shorter time to clinical improvement and faster viral clearance with favipiravir. |
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Early treatment study
Early treatment study
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| 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.
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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, Europe, preprint, 31 authors.
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Late |
Zhaao et al., Biomedicine & Pharmacotherapy, doi:10.1016/j.biopha.2020.110825 (Peer Reviewed) |
Tocilizumab combined with favipiravir in the treatment of COVID-19: A multicenter trial in a small sample size |
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Small study with 14 combined favipiravir/tocilizumab, 7 favipiravir, and 5 tocilizumab patients suggesting that tocilizumab combined with or without favipiravir can improve pulmonary inflammation and inhibit progression. |
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Late treatment study
Late treatment study
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| Zhaao et al., Biomedicine & Pharmacotherapy, doi:10.1016/j.biopha.2020.110825 (Peer Reviewed) |
| Tocilizumab combined with favipiravir in the treatment of COVID-19: A multicenter trial in a small sample size |
Small study with 14 combined favipiravir/tocilizumab, 7 favipiravir, and 5 tocilizumab patients suggesting that tocilizumab combined with or without favipiravir can improve pulmonary inflammation and inhibit progression.
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Zhaao et al., 9/30/2020, peer-reviewed, 12 authors.
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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 |
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Details
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.. |
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Late treatment study
Late treatment study
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| 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.
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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, Europe, peer-reviewed, 21 authors.
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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 |
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Comparison of 35 FPV patients and 35 LPV/RTV patients, showing significant improvements in chest CT and faster viral clearance with FPV. |
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Late treatment study
Late treatment study
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| 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.
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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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