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

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

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

Treatments: Drug: FOY-305; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04657497

FOY-305-01

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

155 participants in 2 patient groups, including a placebo group

FOY-305 group

Experimental group

Description:

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.

Treatment:

Drug: FOY-305

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo