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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04657497

Enrollment

155

Registered

2020-12-08

Start date

2020-11-09

Completion date

2021-04-09

Last updated

2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection (COVID-19)

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.

Interventions

DRUGFOY-305

Specified Dosage and Duration of Treatment

DRUGPlacebo

Specified Dosage and Duration of Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026