Safety and efficacy of favipiravir and camostat mesilate in patients with COVID-19.

JRCT ID: jRCTs031200436

Registered date:23/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 13/05/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): oral administration of favipiravir, favipiravir plus camostat mesilate, or neither favipiravir nor camostat mesilate in patients with COVID-19.

Outcome(s)

• Primary Outcome: expected proportion and 95% CI of SARS-CoV-2 disappearance on the 10th day after starting the treatment.
• Secondary Outcome: expected value and 95% CI of ratio of C-reactive protein before versus on the 10th day after starting the treatment.

Key inclusion & exclusion criteria

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

Include criteria

1) SARS-CoV-2 test positive
2) diagnosed with COVID-19
3) fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan
4) hospital admission
6) patients who have given written consent to participate in the study

Exclude criteria

1) pregnancy
2) lactation
3) Women who are not able to give informed consent regarding contraception and using contraceptive divices from the initiation of favipiravir to 14 days after the end of its administration. Men or their partners who are not able to give informed consent regarding contraception and using contraceptive divices from the initiation of favipiravir to 10 days after the end of its administration.

Related Information

• Primary Sponsor: Yutaka Tokue
• Secondary Sponsor: Nakamura Tetsuya