A Phase III Confirmatory Study of K-237
- Conditions
- Covid19
- Interventions
- Drug: Placebo 0.3-0.4mg/kg (once daily)Drug: K-237 0.3-0.4mg/kg (once daily)
- Registration Number
- NCT05056883
- Lead Sponsor
- Kowa Company, Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1030
Persons who meet all of the following criteria will be eligible for this clinical trial.
- Males and females who are 12 years of age or older at the time of obtaining consent
- Those who are confirmed positive for SARS-CoV-2 by antigen test or RT-PCR test using specimens (nasopharynx, nasal cavity, oropharynx, or saliva) collected within 120 hours prior to obtaining consent.
- Patients who have fevers (37.5 degrees Celsius or higher) and/or at least one of the following symptoms of Score 2 or higher at a screening test: Myalgia, sore throat, diarrhea, nausea, vomiting, cough, and shortness of breath.
- Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.
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Subjects who meet any one of the following criteria will be excluded from this study.
- Patients who have had symptoms caused by COVID-19 for more than 6 days on the day of initiation of study drug administration (Day 1) with the day of onset of symptoms as Day 0.
- Patients who need to receive concomitant therapy or administration of prohibited drugs during the study period
- Patients who have taken or received drugs that have or may have antiviral activity against SARS-CoV-2 within 2 weeks prior to the start of study drug administration.
- Patients currently using antiviral drugs
- Patients with suspected complications of infectious diseases other than COVID-19
- Subjects with a history of COVID-19 within 1 month prior to obtaining consent
- Persons whose weight at the time of the screening test falls into the following categories (The first decimal place of the weight shall be rounded off.) 1) Those who are 18 years of age or older at the time of consent and weigh less than 25 kg or more than 127 kg 2) Those who are between 12 and 18 years of age and weigh less than 40 kg or 127 kg or more at the time of obtaining consent.
- Patients undergoing dialysis treatment
- Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
- Patients with poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or higher or diastolic blood pressure (DBP) of 110 mmHg or higher)
- Patients with complications of diabetic retinopathy, diabetic nephropathy, or diabetic neuropathy
- Patients with heart failure of NYHA Class III or higher
- Patients with malignant tumors or those judged to have a high possibility of recurrence
- Patients requiring oxygen therapy
- A person who has a complication of methemoglobinemia or any other disease that may cause measurement error of the pulse oximeter
- Patients with a history of serious drug allergy (anaphylactic shock, etc.)
- Pregnant women, lactating women, or women who plan to become pregnant or lactate during the study period
- Subjects who have had more than 400 mL of whole blood drawn within 16 weeks or more than 200 mL within 4 weeks prior to obtaining consent, or component blood (plasma and platelet components) drawn within 2 weeks
- Patients who have been administered IVM.
- Those who have participated in other clinical trials and received medication at the time of obtaining consent, or those who have received an investigational drug other than placebo for less than 16 weeks
- Others who are judged by the investigator or others to be inappropriate to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control A Placebo 0.3-0.4mg/kg (once daily) Placebo (once daily) Treatment A K-237 0.3-0.4mg/kg (once daily) K-237 0.3-0.4mg/kg (once daily)
- Primary Outcome Measures
Name Time Method Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend Day1～11 after administration
- Secondary Outcome Measures
Name Time Method 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 ˚C without the use of antipyretics (acetaminophen) Day1～11 after administration
Trial Locations
- Locations (55)
Minami Nagano Clinic
🇯🇵Nagano, Japan
National Hospital Organization Kanazawa Medical Center
🇯🇵Ishikawa, Japan
Sakaide City Hospital
🇯🇵Kagawa, Japan
Tenyoukai Central Hospital
🇯🇵Kagoshima, Japan
Maekawa Medical Clinic
🇯🇵Kanagawa, Japan
Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital
🇯🇵Nagasaki, Japan
Japan Community Health care Organization Osaka Minato Central Hospital
🇯🇵Osaka, Japan
Omi Medical Center
🇯🇵Shiga, Japan
Tokyo center clinic
🇯🇵Tokyo, Japan
Kuramochi Clinic Interpark
🇯🇵Tochigi, Japan
Nagoya City University West Medical Center
🇯🇵Aichi, Japan
Hosokawa Surgical Clinic
🇯🇵Aichi, Japan
Nagoya City University East Medical Center
🇯🇵Aichi, Japan
Naika Tonyobyonaika Maejima Iin
🇯🇵Aichi, Japan
Nagoya City University Hospital
🇯🇵Aichi, Japan
Kamagaya General Hospital
🇯🇵Chiba, Japan
Japan Community Health care Organization Funabashi Central Hospital
🇯🇵Chiba, Japan
National Hospital Organization Fukuokahigashi Medical Center
🇯🇵Fukuoka, Japan
Tohno Chuo Clinic
🇯🇵Aichi, Japan
International University of Health and Welfare Narita Hospital
🇯🇵Chiba, Japan
Fukuoka Kinen Hospital
🇯🇵Fukuoka, Japan
Japan Community Health care Organization Hokkaido Hospital
🇯🇵Hokkaido, Japan
National Hospital Organization Takasaki General Medical Center
🇯🇵Gunma, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Kawasaki Rinko General Hospital
🇯🇵Kanagawa, Japan
Matsuba Clinic
🇯🇵Kanagawa, Japan
Tsuzuki Azuma Clinic Primary care and Rheumatology
🇯🇵Kanagawa, Japan
Mutsukawa Clinic Primary care and Gastroenterology
🇯🇵Kanagawa, Japan
Kitasato University Hospital
🇯🇵Kanagawa, Japan
Sakura Jyuji Hospital, Sakurajyuji Medical Corporation
🇯🇵Kumamoto, Japan
NHO Kumamoto Saishun Medical Center
🇯🇵Kumamoto, Japan
Ikoma City Hospital
🇯🇵Nara, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Nagaoka Chuo General Hospital
🇯🇵Niigata, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama, Japan
Tazuke Kofukai Medical Research Institute, Kitano Hospital
🇯🇵Osaka, Japan
Rinku General Medical Center
🇯🇵Osaka, Japan
Shimamura Memorial Hospital
🇯🇵Tokyo, Japan
Tokyo Saiseikai Central Hospital
🇯🇵Tokyo, Japan
Sumida General Clinic
🇯🇵Tokyo, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Tokyo, Japan
Koto Hospital
🇯🇵Tokyo, Japan
Mishuku Hospital
🇯🇵Tokyo, Japan
Edogawa Hospital
🇯🇵Tokyo, Japan
Minamino Cardiovascular Hospital
🇯🇵Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Tokyo, Japan
Ome Municipal General Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Japan Organization of Occupational Health and Safety Toyama Rosai Hospital
🇯🇵Toyama, Japan
Toyama City Hospital
🇯🇵Toyama, Japan
Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital
🇯🇵Wakayama, Japan
National Hospital Organization Minami Wakayama Medical Center
🇯🇵Wakayama, Japan
Bamrasnaradura Infectious Diseases Institute
🇹🇭Nonthaburi, Thailand
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Ratchaburi Hospital
🇹🇭Ratchaburi Provinc, Thailand