A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)

Phase 3

Completed

• Conditions: SARS-CoV-2 Infection (COVID-19)
• Interventions: Drug: FOY-305; Drug: Placebo

• 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

Study Timeline

• Study Start: 2020-11-09
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-08
• Primary Completion: 2021-03-26
• Study Completion: 2021-04-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1. Inpatient or outpatient: Inpatient
2. Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
3. 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)

Exclusion Criteria

1. Receiving oxygen therapy
2. Difficulty in swallowing oral medication
3. History of COVID-19
4. History of vaccination against COVID-19
5. 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)

Aichi Clinical Site 1; 🇯🇵 Tokoname, Aichi, Japan

Chiba Clinical Site 1; 🇯🇵 Narita, Chiba, Japan

Fukuoka Clinical Site 1; 🇯🇵 Okawa, Fukuoka, Japan

Ibaraki Clinical Site 1; 🇯🇵 Tsuchiura, Ibaraki, Japan

Ishikawa Clinical Site 1; 🇯🇵 Kanazawa, Ishikawa, Japan

Kanagawa Clinical Site 3; 🇯🇵 Kawasaki, Kanagawa, Japan

Kanagawa Clinical Site 1; 🇯🇵 Yokohama, Kanagawa, Japan

Kanagawa Clinical Site 2; 🇯🇵 Yokosuka, Kanagawa, Japan

Mie Clinical Site 1; 🇯🇵 Yokkaichi, Mie, Japan

Niigata Clinical Site 1; 🇯🇵 Nagaoka, Niigata, Japan

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