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The efficacy and safety of K-237 0.3-0.4 mg/kg orally administered once daily for 3 days will be evaluated in patients with mild COVID-19 using a randomized, double-blind, parallel-group comparative method with placebo as a control. Efficacy will be assessed using a stratified log-rank test to determine the superiority of the drug over placebo in terms of time to improvement in clinical symptoms from the start of study drug administration to 168 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | K-237 0.3-0.4mg/kg (once daily) |
|
| Control A | Placebo Comparator | Placebo (once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-237 0.3-0.4mg/kg (once daily) | Drug | Ivermectin 3mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend | Day1~11 after administration |
| Measure | Description | Time Frame |
|---|---|---|
| In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal | Day1~11 after administration | |
| Time to reach a temperature of less than 37.5 ËšC without the use of antipyretics (acetaminophen) |
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Inclusion Criteria:
Persons who meet all of the following criteria will be eligible for this clinical trial.
Exclusion Criteria:
Subjects who meet any one of the following criteria will be excluded from this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosokawa Surgical Clinic | Aichi | 453-0812 | Japan | |||
| Nagoya City University West Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38154616 | Result | Mikamo H, Takahashi S, Yamagishi Y, Hirakawa A, Harada T, Nagashima H, Noguchi C, Masuko K, Maekawa H, Kashii T, Ohbayashi H, Hosokawa S, Maejima K, Yamato M, Manosuthi W, Paiboonpol S, Suganami H, Tanigawa R, Kawamura H; IVERMILCO Study Group. Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand. J Infect Chemother. 2024 Jun;30(6):536-543. doi: 10.1016/j.jiac.2023.12.012. Epub 2023 Dec 27. |
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| Placebo 0.3-0.4mg/kg (once daily) | Drug | Placebo 3mg tablet |
|
| Day1~11 after administration |
| Aichi |
| 462-8508 |
| Japan |
| Nagoya City University East Medical Center | Aichi | 464-8547 | Japan |
| Naika Tonyobyonaika Maejima Iin | Aichi | 466-0013 | Japan |
| Nagoya City University Hospital | Aichi | 467-8602 | Japan |
| Tohno Chuo Clinic | Aichi | 509-6134 | Japan |
| Kamagaya General Hospital | Chiba | 273-0121 | Japan |
| Japan Community Health care Organization Funabashi Central Hospital | Chiba | 273-8556 | Japan |
| International University of Health and Welfare Narita Hospital | Chiba | 286-8520 | Japan |
| National Hospital Organization Fukuokahigashi Medical Center | Fukuoka | 811-3195 | Japan |
| Fukuoka Kinen Hospital | Fukuoka | 814-8525 | Japan |
| National Hospital Organization Takasaki General Medical Center | Gunma | 370-0829 | Japan |
| Hiroshima Prefectural Hospital | Hiroshima | 734-8530 | Japan |
| Japan Community Health care Organization Hokkaido Hospital | Hokkaido | 062-8618 | Japan |
| National Hospital Organization Kanazawa Medical Center | Ishikawa | 920-8650 | Japan |
| Sakaide City Hospital | Kagawa | 762-8550 | Japan |
| Tenyoukai Central Hospital | Kagoshima | 892-0822 | Japan |
| Kawasaki Rinko General Hospital | Kanagawa | 210-0806 | Japan |
| Matsuba Clinic | Kanagawa | 212-0024 | Japan |
| Maekawa Medical Clinic | Kanagawa | 220-0004 | Japan |
| Tsuzuki Azuma Clinic Primary care and Rheumatology | Kanagawa | 224-0041 | Japan |
| Mutsukawa Clinic Primary care and Gastroenterology | Kanagawa | 232-0066 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| NHO Kumamoto Saishun Medical Center | Kumamoto | 861-1196 | Japan |
| Sakura Jyuji Hospital, Sakurajyuji Medical Corporation | Kumamoto | 861-4173 | Japan |
| Minami Nagano Clinic | Nagano | 381-2217 | Japan |
| Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital | Nagasaki | 857-0134 | Japan |
| Ikoma City Hospital | Nara | 630-0213 | Japan |
| Nagaoka Chuo General Hospital | Niigata | 940-0861 | Japan |
| Okayama City General Medical Center Okayama City Hospital | Okayama | 700-8557 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Tazuke Kofukai Medical Research Institute, Kitano Hospital | Osaka | 530-8480 | Japan |
| Japan Community Health care Organization Osaka Minato Central Hospital | Osaka | 552-0003 | Japan |
| Rinku General Medical Center | Osaka | 598-8577 | Japan |
| Omi Medical Center | Shiga | 525-8585 | Japan |
| Kuramochi Clinic Interpark | Tochigi | 321-0114 | Japan |
| Tokyo center clinic | Tokyo | 103-0028 | Japan |
| Tokyo Saiseikai Central Hospital | Tokyo | 108-0073 | Japan |
| Kitasato University Kitasato Institute Hospital | Tokyo | 108-8642 | Japan |
| Sumida General Clinic | Tokyo | 130-0012 | Japan |
| Edogawa Hospital | Tokyo | 133-0052 | Japan |
| Koto Hospital | Tokyo | 136-0072 | Japan |
| Mishuku Hospital | Tokyo | 153-0051 | Japan |
| Shimamura Memorial Hospital | Tokyo | 177-0051 | Japan |
| Minamino Cardiovascular Hospital | Tokyo | 192-0918 | Japan |
| Tokyo Medical University Hachioji Medical Center | Tokyo | 193-0998 | Japan |
| Ome Municipal General Hospital | Tokyo | 198-0042 | Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| Japan Organization of Occupational Health and Safety Toyama Rosai Hospital | Toyama | 937-0042 | Japan |
| Toyama City Hospital | Toyama | 939-8511 | Japan |
| Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital | Wakayama | 640-8505 | Japan |
| National Hospital Organization Minami Wakayama Medical Center | Wakayama | 646-8558 | Japan |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | 11000 | Thailand |
| Ratchaburi Hospital | Ratchaburi Provinc | 70000 | Thailand |
| 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 |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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