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

Primary Purpose

SARS-CoV-2 Infection (COVID-19)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FOY-305
Placebo
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection (COVID-19)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aichi Clinical Site 1
  • Chiba Clinical Site 1
  • Fukuoka Clinical Site 1
  • Ibaraki Clinical Site 1
  • Ishikawa Clinical Site 1
  • Kanagawa Clinical Site 3
  • Kanagawa Clinical Site 1
  • Kanagawa Clinical Site 2
  • Mie Clinical Site 1
  • Niigata Clinical Site 1
  • Osaka Clinical Site 2
  • Saitama Clinical Site 3
  • Saitama Clinical Site 1
  • Saitama Clinical Site 2
  • Tokyo Clinical Site 5
  • Tokyo Clinical Site 9
  • Tokyo Clinical Site1
  • Tokyo Clinical Site 7
  • Tokyo Clinical Site 3
  • Tokyo Clinical Site 4
  • Tokyo Clinical Site 8
  • Tokyo Clinical Site2
  • Tokyo Clinical Site 6
  • Okayama Clinical Site 1
  • Osaka Clinical Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FOY-305 group

Placebo group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the local laboratory

Secondary Outcome Measures

Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the central laboratory
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)
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.
Proportion of subjects on mechanical ventilator
Proportion of subjects on mechanical ventilator
Survival status (alive/death)
Proportion of subjects alive or death

Full Information

First Posted
November 9, 2020
Last Updated
June 11, 2021
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04657497
Brief Title
A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)
Official Title
A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection (COVID-19)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOY-305 group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
FOY-305
Intervention Description
Specified Dosage and Duration of Treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified Dosage and Duration of Treatment
Primary Outcome Measure Information:
Title
Time to SARS-CoV-2 negative test
Description
Time to SARS-CoV-2 negative test as assessed by the local laboratory
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Time to SARS-CoV-2 negative test
Description
Time to SARS-CoV-2 negative test as assessed by the central laboratory
Time Frame
Up to 14 days
Title
Proportion of subjects who test negative for SARS-CoV-2
Description
Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)
Time Frame
Up to 14 days
Title
Ordinal scale for severity
Description
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.
Time Frame
Up to 14 days
Title
Proportion of subjects on mechanical ventilator
Description
Proportion of subjects on mechanical ventilator
Time Frame
Up to 14 days
Title
Survival status (alive/death)
Description
Proportion of subjects alive or death
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoyuki Komura
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Clinical Site 1
City
Tokoname
State/Province
Aichi
Country
Japan
Facility Name
Chiba Clinical Site 1
City
Narita
State/Province
Chiba
Country
Japan
Facility Name
Fukuoka Clinical Site 1
City
Okawa
State/Province
Fukuoka
Country
Japan
Facility Name
Ibaraki Clinical Site 1
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
Facility Name
Ishikawa Clinical Site 1
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Kanagawa Clinical Site 3
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site 1
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site 2
City
Yokosuka
State/Province
Kanagawa
Country
Japan
Facility Name
Mie Clinical Site 1
City
Yokkaichi
State/Province
Mie
Country
Japan
Facility Name
Niigata Clinical Site 1
City
Nagaoka
State/Province
Niigata
Country
Japan
Facility Name
Osaka Clinical Site 2
City
Daito
State/Province
Osaka
Country
Japan
Facility Name
Saitama Clinical Site 3
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Saitama Clinical Site 1
City
Kuki
State/Province
Saitama
Country
Japan
Facility Name
Saitama Clinical Site 2
City
Kumagaya
State/Province
Saitama
Country
Japan
Facility Name
Tokyo Clinical Site 5
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 9
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site1
City
Hachioji
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 7
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 3
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 4
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 8
City
Sibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Sibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 6
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Okayama Clinical Site 1
City
Okayama
Country
Japan
Facility Name
Osaka Clinical Site 1
City
Osaka
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html
Citations:
PubMed Identifier
36163020
Citation
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. Erratum In: BMC Med. 2022 Dec 8;20(1):478.
Results Reference
derived

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

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