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

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04657497
Collaborator
(none)
155
Enrollment
25
Locations
2
Arms
5
Actual Duration (Months)
6.2
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
Actual Study Start Date :
Nov 9, 2020
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Apr 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: FOY-305 group

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
Specified Dosage and Duration of Treatment
Placebo Comparator: Placebo group

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
Specified Dosage and Duration of Treatment

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Time to SARS-CoV-2 negative test [Up to 14 days]

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

  2. 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)

  3. 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.

  4. Proportion of subjects on mechanical ventilator [Up to 14 days]

    Proportion of subjects on mechanical ventilator

  5. Survival status (alive/death) [Up to 14 days]

    Proportion of subjects alive or death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aichi Clinical Site 1 Tokoname Aichi Japan
2 Chiba Clinical Site 1 Narita Chiba Japan
3 Fukuoka Clinical Site 1 Okawa Fukuoka Japan
4 Ibaraki Clinical Site 1 Tsuchiura Ibaraki Japan
5 Ishikawa Clinical Site 1 Kanazawa Ishikawa Japan
6 Kanagawa Clinical Site 3 Kawasaki Kanagawa Japan
7 Kanagawa Clinical Site 1 Yokohama Kanagawa Japan
8 Kanagawa Clinical Site 2 Yokosuka Kanagawa Japan
9 Mie Clinical Site 1 Yokkaichi Mie Japan
10 Niigata Clinical Site 1 Nagaoka Niigata Japan
11 Osaka Clinical Site 2 Daito Osaka Japan
12 Saitama Clinical Site 3 Kawagoe Saitama Japan
13 Saitama Clinical Site 1 Kuki Saitama Japan
14 Saitama Clinical Site 2 Kumagaya Saitama Japan
15 Tokyo Clinical Site 5 Bunkyo-ku Tokyo Japan
16 Tokyo Clinical Site 9 Bunkyo-ku Tokyo Japan
17 Tokyo Clinical Site1 Hachioji Tokyo Japan
18 Tokyo Clinical Site 7 Itabashi-ku Tokyo Japan
19 Tokyo Clinical Site 3 Meguro-ku Tokyo Japan
20 Tokyo Clinical Site 4 Shinagawa-ku Tokyo Japan
21 Tokyo Clinical Site 8 Sibuya-ku Tokyo Japan
22 Tokyo Clinical Site2 Sibuya-ku Tokyo Japan
23 Tokyo Clinical Site 6 Tachikawa Tokyo Japan
24 Okayama Clinical Site 1 Okayama Japan
25 Osaka Clinical Site 1 Osaka Japan

Sponsors and Collaborators

  • Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Naoyuki Komura, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT04657497
Other Study ID Numbers:
  • FOY-305-01
First Posted:
Dec 8, 2020
Last Update Posted:
Jun 14, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Infections
Communicable Diseases
COVID-19
Camostat

Study Results

No Results Posted as of Jun 14, 2021