A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)
- Registration Number
- NCT04657497
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Inpatient or outpatient: Inpatient
- Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
- Enrollment in this study within 5 days after onset of symptoms of SARS-CoV-2 infection (COVID-19) (for asymptomatic patients, enrollment in this study within 5 days after collection of the sample that tested positive)
- Receiving oxygen therapy
- Difficulty in swallowing oral medication
- History of COVID-19
- History of vaccination against COVID-19
- Taking camostat mesilate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOY-305 group FOY-305 Camostat Mesilate tablets 600 mg will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days. Placebo group Placebo Placebo tablets will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days.
- Primary Outcome Measures
Name Time Method Time to SARS-CoV-2 negative test Up to 14 days Time to SARS-CoV-2 negative test as assessed by the local laboratory
- Secondary Outcome Measures
Name Time Method Time to SARS-CoV-2 negative test Up to 14 days Time to SARS-CoV-2 negative test as assessed by the central laboratory
Proportion of subjects who test negative for SARS-CoV-2 Up to 14 days Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)
Ordinal scale for severity Up to 14 days Ordinal scale for severity. The minimum score is 0: No clinical or virological evidence of infection, representing the better outcome, and the maximum value is 8: Death, representing the worse outcome.
Proportion of subjects on mechanical ventilator Up to 14 days Proportion of subjects on mechanical ventilator
Survival status (alive/death) Up to 14 days Proportion of subjects alive or death
Trial Locations
- Locations (25)
Tokyo Clinical Site 9
🇯🇵Bunkyo-ku, Tokyo, Japan
Kanagawa Clinical Site 3
🇯🇵Kawasaki, Kanagawa, Japan
Saitama Clinical Site 2
🇯🇵Kumagaya, Saitama, Japan
Niigata Clinical Site 1
🇯🇵Nagaoka, Niigata, Japan
Kanagawa Clinical Site 1
🇯🇵Yokohama, Kanagawa, Japan
Aichi Clinical Site 1
🇯🇵Tokoname, Aichi, Japan
Tokyo Clinical Site 5
🇯🇵Bunkyo-ku, Tokyo, Japan
Ishikawa Clinical Site 1
🇯🇵Kanazawa, Ishikawa, Japan
Tokyo Clinical Site1
🇯🇵Hachioji, Tokyo, Japan
Saitama Clinical Site 1
🇯🇵Kuki, Saitama, Japan
Tokyo Clinical Site 4
🇯🇵Shinagawa-ku, Tokyo, Japan
Tokyo Clinical Site 6
🇯🇵Tachikawa, Tokyo, Japan
Tokyo Clinical Site 8
🇯🇵Sibuya-ku, Tokyo, Japan
Osaka Clinical Site 1
🇯🇵Osaka, Japan
Tokyo Clinical Site 3
🇯🇵Meguro-ku, Tokyo, Japan
Tokyo Clinical Site2
🇯🇵Sibuya-ku, Tokyo, Japan
Tokyo Clinical Site 7
🇯🇵Itabashi-ku, Tokyo, Japan
Fukuoka Clinical Site 1
🇯🇵Okawa, Fukuoka, Japan
Chiba Clinical Site 1
🇯🇵Narita, Chiba, Japan
Mie Clinical Site 1
🇯🇵Yokkaichi, Mie, Japan
Kanagawa Clinical Site 2
🇯🇵Yokosuka, Kanagawa, Japan
Osaka Clinical Site 2
🇯🇵Daito, Osaka, Japan
Okayama Clinical Site 1
🇯🇵Okayama, Japan
Ibaraki Clinical Site 1
🇯🇵Tsuchiura, Ibaraki, Japan
Saitama Clinical Site 3
🇯🇵Kawagoe, Saitama, Japan