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)

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection (COVID-19)
• Intervention / Treatment: Drug: FOY-305; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): April 9, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Camostat
• Other Study ID Numbers: FOY-305-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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