A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)
NCT ID: NCT04657497
Last Updated: 2024-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2020-11-09
2021-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
FOY-305
Specified Dosage and Duration of Treatment
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.
Placebo
Specified Dosage and Duration of Treatment
Interventions
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FOY-305
Specified Dosage and Duration of Treatment
Placebo
Specified Dosage and Duration of Treatment
Eligibility Criteria
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Inclusion Criteria
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
2. Difficulty in swallowing oral medication
3. History of COVID-19
4. History of vaccination against COVID-19
5. Taking camostat mesilate
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Naoyuki Komura
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aichi Clinical Site 1
Tokoname, Aichi-ken, Japan
Chiba Clinical Site 1
Narita, Chiba, Japan
Fukuoka Clinical Site 1
Ōkawa, Fukuoka, Japan
Ibaraki Clinical Site 1
Tsuchiura, Ibaraki, Japan
Ishikawa Clinical Site 1
Kanazawa, Ishikawa-ken, Japan
Kanagawa Clinical Site 3
Kawasaki, Kanagawa, Japan
Kanagawa Clinical Site 1
Yokohama, Kanagawa, Japan
Kanagawa Clinical Site 2
Yokosuka, Kanagawa, Japan
Mie Clinical Site 1
Yokkaichi, Mie-ken, Japan
Niigata Clinical Site 1
Nagaoka, Niigata, Japan
Osaka Clinical Site 2
Daitō, Osaka, Japan
Saitama Clinical Site 3
Kawagoe, Saitama, Japan
Saitama Clinical Site 1
Kukichūō, Saitama, Japan
Saitama Clinical Site 2
Kumagaya, Saitama, Japan
Tokyo Clinical Site 5
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site 9
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site1
Hachiōji, Tokyo, Japan
Tokyo Clinical Site 7
Itabashi-ku, Tokyo, Japan
Tokyo Clinical Site 3
Meguro-ku, Tokyo, 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
Okayama Clinical Site 1
Okayama, , Japan
Osaka Clinical Site 1
Osaka, , Japan
Countries
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References
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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.
Other Identifiers
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FOY-305-01
Identifier Type: -
Identifier Source: org_study_id
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