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

NCT04657497 | Completed Phase 3 DMC

• 1 other identifier: FOY-305-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 25

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.

Conditions

SARS-CoV-2 Infection (COVID-19)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to SARS-CoV-2 negative test

  Up to 14 days

• Proportion of subjects who test negative for SARS-CoV-2

  Up to 14 days

• Ordinal scale for severity

  Up to 14 days

• Proportion of subjects on mechanical ventilator

  Up to 14 days

• Survival status (alive/death)

  Up to 14 days

Study Arms (2)

FOY-305 group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

FOY-305 DRUG

Specified Dosage and Duration of Treatment

FOY-305 group

Placebo DRUG

Specified Dosage and Duration of Treatment

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Receiving oxygen therapy
• Difficulty in swallowing oral medication
• History of COVID-19
• History of vaccination against COVID-19
• Taking camostat mesilate

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (25)

Aichi Clinical Site 1

Tokoname, Aichi-ken, Japan

Location

Chiba Clinical Site 1

Narita, Chiba, Japan

Location

Fukuoka Clinical Site 1

Ōkawa, Fukuoka, Japan

Location

Ibaraki Clinical Site 1

Tsuchiura, Ibaraki, Japan

Location

Ishikawa Clinical Site 1

Kanazawa, Ishikawa-ken, Japan

Location

Kanagawa Clinical Site 3

Kawasaki, Kanagawa, Japan

Location

Kanagawa Clinical Site 1

Yokohama, Kanagawa, Japan

Location

Kanagawa Clinical Site 2

Yokosuka, Kanagawa, Japan

Location

Mie Clinical Site 1

Yokkaichi, Mie-ken, Japan

Location

Niigata Clinical Site 1

Nagaoka, Niigata, Japan

Location

Osaka Clinical Site 2

Daitō, Osaka, Japan

Location

Saitama Clinical Site 3

Kawagoe, Saitama, Japan

Location

Saitama Clinical Site 1

Kukichūō, Saitama, Japan

Location

Saitama Clinical Site 2

Kumagaya, Saitama, Japan

Location

Tokyo Clinical Site 5

Bunkyo-ku, Tokyo, Japan

Location

Tokyo Clinical Site 9

Bunkyo-ku, Tokyo, Japan

Location

Tokyo Clinical Site1

Hachiōji, Tokyo, Japan

Location

Tokyo Clinical Site 7

Itabashi-ku, Tokyo, Japan

Location

Tokyo Clinical Site 3

Meguro-ku, Tokyo, Japan

Location

Tokyo Clinical Site 4

Shinagawa-ku, Tokyo, Japan

Location

Tokyo Clinical Site 8

Sibuya-ku, Tokyo, Japan

Location

Tokyo Clinical Site2

Sibuya-ku, Tokyo, Japan

Location

Tokyo Clinical Site 6

Tachikawa, Tokyo, Japan

Location

Okayama Clinical Site 1

Okayama, Japan

Location

Osaka Clinical Site 1

Osaka, Japan

Location

Related Publications (1)

• Kinoshita T, Shinoda M, Nishizaki Y, Shiraki K, Hirai Y, Kichikawa Y, Tsushima K, Shinkai M, Komura N, Yoshida K, Kido Y, Kakeya H, Uemura N, Kadota J. A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study). BMC Med. 2022 Sep 27;20(1):342. doi: 10.1186/s12916-022-02518-7.

  PMID: 36163020 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Naoyuki Komura

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 8, 2020
• Study Start: November 9, 2020
• Primary Completion: March 26, 2021
• Study Completion: April 9, 2021
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (25)