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

SARS-CoV-2 Infection (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657497
• Other study ID #: FOY-305-01
• Status: Completed
• Phase: Phase 3
• Start date: November 9, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 9, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2 Infection (COVID-19)

Intervention

Drug:
• FOY-305
Specified Dosage and Duration of Treatment
• Placebo
Specified Dosage and Duration of Treatment

Locations

Country	Name	City	State
Japan	Tokyo Clinical Site 5	Bunkyo-ku	Tokyo
Japan	Tokyo Clinical Site 9	Bunkyo-ku	Tokyo
Japan	Osaka Clinical Site 2	Daito	Osaka
Japan	Tokyo Clinical Site1	Hachioji	Tokyo
Japan	Tokyo Clinical Site 7	Itabashi-ku	Tokyo
Japan	Ishikawa Clinical Site 1	Kanazawa	Ishikawa
Japan	Saitama Clinical Site 3	Kawagoe	Saitama
Japan	Kanagawa Clinical Site 3	Kawasaki	Kanagawa
Japan	Saitama Clinical Site 1	Kuki	Saitama
Japan	Saitama Clinical Site 2	Kumagaya	Saitama
Japan	Tokyo Clinical Site 3	Meguro-ku	Tokyo
Japan	Niigata Clinical Site 1	Nagaoka	Niigata
Japan	Chiba Clinical Site 1	Narita	Chiba
Japan	Fukuoka Clinical Site 1	Okawa	Fukuoka
Japan	Okayama Clinical Site 1	Okayama
Japan	Osaka Clinical Site 1	Osaka
Japan	Tokyo Clinical Site 4	Shinagawa-ku	Tokyo
Japan	Tokyo Clinical Site 8	Sibuya-ku	Tokyo
Japan	Tokyo Clinical Site2	Sibuya-ku	Tokyo
Japan	Tokyo Clinical Site 6	Tachikawa	Tokyo
Japan	Aichi Clinical Site 1	Tokoname	Aichi
Japan	Ibaraki Clinical Site 1	Tsuchiura	Ibaraki
Japan	Mie Clinical Site 1	Yokkaichi	Mie
Japan	Kanagawa Clinical Site 1	Yokohama	Kanagawa
Japan	Kanagawa Clinical Site 2	Yokosuka	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to SARS-CoV-2 negative test	Time to SARS-CoV-2 negative test as assessed by the central laboratory	Up to 14 days
Secondary	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
Secondary	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
Secondary	Proportion of subjects on mechanical ventilator	Proportion of subjects on mechanical ventilator	Up to 14 days
Secondary	Survival status (alive/death)	Proportion of subjects alive or death	Up to 14 days