Phase III clinical trial of favipiravir in early-onset COVID-19 patients with severe risk factors

Phase III clinical trial of favipiravir in early-onset COVID-19 patients with severe risk factors -Placebo-controlled, stratified Randomized, Multicenter, Double-blind study -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210004

Enrollment

316

Registered

2021-04-14

Start date

2021-04-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 patients with risk factors of progression to severe disease onset within 72 hours prior to

Interventions

Favipiravir group: T-705a tablets 200 mg are administrated orally, 9 tablets twice daily for Day 1 and 4 tablets twice daily for Day 2 to 10. Placebo group: Placebo tablets are administered orally, 9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with positive SARS-CoV-2 test result by RT-PCR or loop-mediated isothermal amplification (LAMP) method or antigen test. 2.Patient within 72 hours from onset of first COVID-19 symptom 3.Patients with risk factors of progression to severe disease 4.Have a negative pregnancy test before study treatment 5.Patients can obtain written informed consent from the patients. 6.Other

Exclusion criteria

Exclusion criteria: 1.Patients receiving oxygen therapy prior to the start of study treatment. 2.Patients with any of COVID-19 clinical symptoms/findings of dyspnea or a respiratory rate of 30 breaths/min or more. 3.Patients with SARS-CoV-2 vaccinated

Design outcomes

Primary

Measure	Time frame
Percentage of patients with severe disease from randomization to Day 28	—

Secondary

Measure	Time frame
1.Efficacy Endpoints Incidence of progression to severe disease by Day 15 Change in the viral load of SARS-CoV-2 Time to negative for SARS-CoV-2 Change in the percentage of SARS-CoV-2 becoming negative Time to progression to severe disease symptoms and findings Duration of oxygenation 2.Pharmacokinetics and PK-PD Endpoints Plasma concentrations of favipiravir over time PK prameters (AUC0-24, Cmax, Cmin) for favipiravir 3.Safety Endpoints Adverse events Laboratory tests Vital signs	—

Measure

Time frame

1.Efficacy Endpoints Incidence of progression to severe disease by Day 15 Change in the viral load of SARS-CoV-2 Time to negative for SARS-CoV-2 Change in the percentage of SARS-CoV-2 becoming negative Time to progression to severe disease symptoms and findings Duration of oxygenation 2.Pharmacokinetics and PK-PD Endpoints Plasma concentrations of favipiravir over time PK prameters (AUC0-24, Cmax, Cmin) for favipiravir 3.Safety Endpoints Adverse events Laboratory tests Vital signs

—

Contacts

Public ContactClinical Trial Information Officer

FUJIFILM Toyama Chemical Co., Ltd

fftc-clinicaltrial-info1@fujifilm.com+81-3-6228-3129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026