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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOY-305 | Drug | Specified Dosage and Duration of Treatment |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naoyuki Komura | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Clinical Site 1 | Tokoname | Aichi-ken | Japan | |||
| Chiba Clinical Site 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41823222 | Derived | Shapira S, Vishnevsky G, Yaakobi H, Shenberg G, Motlaq M, Liberman E, Kalisky A, Benari G, Tsiodras S, Adi N, Lotvall J, Arber N. Reduced Mortality in COVID-19 Patients Treated With Inhaled Extracellular Vesicles Expressing CD24. J Extracell Vesicles. 2026 Mar;15(3):e70253. doi: 10.1002/jev2.70253. | |
| 36163020 | Derived |
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| Placebo |
| Drug |
Specified Dosage and Duration of Treatment |
|
| 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 |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C034532 | camostat |
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