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

Study Overview
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Brief Summary
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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.

Official Title
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A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)

Conditions
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SARS-CoV-2 Infection (COVID-19)

Intervention / Treatment
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* Drug: FOY-305
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Receiving oxygen therapy Difficulty in swallowing oral medication History of COVID-19 History of vaccination against COVID-19 Taking camostat mesilate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOY-305 group<br>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. | Drug: FOY-305<br>* Specified Dosage and Duration of Treatment<br>|
| Placebo Comparator: Placebo group<br>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. | Drug: Placebo<br>* Specified Dosage and Duration of Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to SARS-CoV-2 negative test | Time to SARS-CoV-2 negative test as assessed by the local laboratory | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to SARS-CoV-2 negative test | Time to SARS-CoV-2 negative test as assessed by the central laboratory | Up to 14 days | 
| Proportion of subjects who test negative for SARS-CoV-2 | Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories) | Up to 14 days | 
| Ordinal scale for severity | 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. | Up to 14 days | 
| Proportion of subjects on mechanical ventilator | Proportion of subjects on mechanical ventilator | Up to 14 days | 
| Survival status (alive/death) | Proportion of subjects alive or death | Up to 14 days |