A Phase III Confirmatory Study of K-237

NCT05056883 | Completed Phase 3

• 1 other identifier: K-237-01
• Study Type: interventional
• Target: 1,030
• Locations: 2 countries
• Sites: 55

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend

  Day1～11 after administration

Secondary Outcomes (2)

• 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

Study Arms (2)

Treatment A

EXPERIMENTAL

K-237 0.3-0.4mg/kg (once daily)

Drug: K-237 0.3-0.4mg/kg (once daily)

Control A

PLACEBO COMPARATOR

Placebo (once daily)

Drug: Placebo 0.3-0.4mg/kg (once daily)

Interventions

K-237 0.3-0.4mg/kg (once daily) DRUG

Ivermectin 3mg tablet

Also known as: Ivermectin 0.3-0.4mg/kg (once daily)

Treatment A

Placebo 0.3-0.4mg/kg (once daily) DRUG

Placebo 3mg tablet

Control A

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (55)

Hosokawa Surgical Clinic

Aichi, 453-0812, Japan

Location

Nagoya City University West Medical Center

Aichi, 462-8508, Japan

Location

Nagoya City University East Medical Center

Aichi, 464-8547, Japan

Location

Naika Tonyobyonaika Maejima Iin

Aichi, 466-0013, Japan

Location

Nagoya City University Hospital

Aichi, 467-8602, Japan

Location

Tohno Chuo Clinic

Aichi, 509-6134, Japan

Location

Kamagaya General Hospital

Chiba, 273-0121, Japan

Location

Japan Community Health care Organization Funabashi Central Hospital

Chiba, 273-8556, Japan

Location

International University of Health and Welfare Narita Hospital

Chiba, 286-8520, Japan

Location

National Hospital Organization Fukuokahigashi Medical Center

Fukuoka, 811-3195, Japan

Location

Fukuoka Kinen Hospital

Fukuoka, 814-8525, Japan

Location

National Hospital Organization Takasaki General Medical Center

Gunma, 370-0829, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, 734-8530, Japan

Location

Japan Community Health care Organization Hokkaido Hospital

Hokkaido, 062-8618, Japan

Location

National Hospital Organization Kanazawa Medical Center

Ishikawa, 920-8650, Japan

Location

Sakaide City Hospital

Kagawa, 762-8550, Japan

Location

Tenyoukai Central Hospital

Kagoshima, 892-0822, Japan

Location

Kawasaki Rinko General Hospital

Kanagawa, 210-0806, Japan

Location

Matsuba Clinic

Kanagawa, 212-0024, Japan

Location

Maekawa Medical Clinic

Kanagawa, 220-0004, Japan

Location

Tsuzuki Azuma Clinic Primary care and Rheumatology

Kanagawa, 224-0041, Japan

Location

Mutsukawa Clinic Primary care and Gastroenterology

Kanagawa, 232-0066, Japan

Location

Kitasato University Hospital

Kanagawa, 252-0375, Japan

Location

NHO Kumamoto Saishun Medical Center

Kumamoto, 861-1196, Japan

Location

Sakura Jyuji Hospital, Sakurajyuji Medical Corporation

Kumamoto, 861-4173, Japan

Location

Minami Nagano Clinic

Nagano, 381-2217, Japan

Location

Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital

Nagasaki, 857-0134, Japan

Location

Ikoma City Hospital

Nara, 630-0213, Japan

Location

Nagaoka Chuo General Hospital

Niigata, 940-0861, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, 700-8557, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Tazuke Kofukai Medical Research Institute, Kitano Hospital

Osaka, 530-8480, Japan

Location

Japan Community Health care Organization Osaka Minato Central Hospital

Osaka, 552-0003, Japan

Location

Rinku General Medical Center

Osaka, 598-8577, Japan

Location

Omi Medical Center

Shiga, 525-8585, Japan

Location

Kuramochi Clinic Interpark

Tochigi, 321-0114, Japan

Location

Tokyo center clinic

Tokyo, 103-0028, Japan

Location

Tokyo Saiseikai Central Hospital

Tokyo, 108-0073, Japan

Location

Kitasato University Kitasato Institute Hospital

Tokyo, 108-8642, Japan

Location

Sumida General Clinic

Tokyo, 130-0012, Japan

Location

Edogawa Hospital

Tokyo, 133-0052, Japan

Location

Koto Hospital

Tokyo, 136-0072, Japan

Location

Mishuku Hospital

Tokyo, 153-0051, Japan

Location

Shimamura Memorial Hospital

Tokyo, 177-0051, Japan

Location

Minamino Cardiovascular Hospital

Tokyo, 192-0918, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

Ome Municipal General Hospital

Tokyo, 198-0042, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Japan Organization of Occupational Health and Safety Toyama Rosai Hospital

Toyama, 937-0042, Japan

Location

Toyama City Hospital

Toyama, 939-8511, Japan

Location

Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital

Wakayama, 640-8505, Japan

Location

National Hospital Organization Minami Wakayama Medical Center

Wakayama, 646-8558, Japan

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Location

Ratchaburi Hospital

Ratchaburi Provinc, 70000, Thailand

Location

Related Publications (1)

• 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.

  PMID: 38154616 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: October 22, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

JP (52); TH (3)