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

JRCT ID: jRCT2041210004

Registered date:14/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19 patients with risk factors of progression to severe disease onset within 72 hours prior to
• Date of first enrollment: 20/04/2021
• Target sample size: 316
• Study type: Interventional

Intervention(s)

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 tablets twice daily for Day 1 and 4 tablets twice daily for Day 2 to 10.

Outcome(s)

• Primary Outcome: Percentage of patients with severe disease from randomization to Day 28

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakurai Tsutomu