A Phase III Confirmatory Study of K-237

NCT ID: NCT05056883

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1030 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2022-08-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Ivermectin 3mg tablet

Control A

Placebo (once daily)

Group Type: PLACEBO_COMPARATOR

Placebo 0.3-0.4mg/kg (once daily)

Intervention Type: DRUG

Placebo 3mg tablet

Interventions

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

Ivermectin 3mg tablet

Intervention Type: DRUG

Placebo 0.3-0.4mg/kg (once daily)

Placebo 3mg tablet

Intervention Type: DRUG

Other Intervention Names

Ivermectin 0.3-0.4mg/kg (once daily)

Eligibility Criteria

Inclusion Criteria

Persons who meet all of the following criteria will be eligible for this clinical trial.

1. Males and females who are 12 years of age or older at the time of obtaining consent

2. 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.

3. 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.

4. Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.

Exclusion Criteria

• Subjects who meet any one of the following criteria will be excluded from this study.

1. 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.

2. Patients who need to receive concomitant therapy or administration of prohibited drugs during the study period

3. 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.

4. Patients currently using antiviral drugs

5. Patients with suspected complications of infectious diseases other than COVID-19

6. Subjects with a history of COVID-19 within 1 month prior to obtaining consent

7. 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.

8. Patients undergoing dialysis treatment

9. Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)

10. Patients with poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or higher or diastolic blood pressure (DBP) of 110 mmHg or higher)

11. Patients with complications of diabetic retinopathy, diabetic nephropathy, or diabetic neuropathy

12. Patients with heart failure of NYHA Class III or higher

13. Patients with malignant tumors or those judged to have a high possibility of recurrence

14. Patients requiring oxygen therapy

15. A person who has a complication of methemoglobinemia or any other disease that may cause measurement error of the pulse oximeter

16. Patients with a history of serious drug allergy (anaphylactic shock, etc.)

17. Pregnant women, lactating women, or women who plan to become pregnant or lactate during the study period

18. 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

19. Patients who have been administered IVM.

20. 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

21. Others who are judged by the investigator or others to be inappropriate to participate in the study.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hosokawa Surgical Clinic

Aichi, , Japan

Nagoya City University West Medical Center

Aichi, , Japan

Nagoya City University East Medical Center

Aichi, , Japan

Naika Tonyobyonaika Maejima Iin

Aichi, , Japan

Nagoya City University Hospital

Aichi, , Japan

Tohno Chuo Clinic

Aichi, , Japan

Kamagaya General Hospital

Chiba, , Japan

Japan Community Health care Organization Funabashi Central Hospital

Chiba, , Japan

International University of Health and Welfare Narita Hospital

Chiba, , Japan

National Hospital Organization Fukuokahigashi Medical Center

Fukuoka, , Japan

Fukuoka Kinen Hospital

Fukuoka, , Japan

National Hospital Organization Takasaki General Medical Center

Gunma, , Japan

Hiroshima Prefectural Hospital

Hiroshima, , Japan

Japan Community Health care Organization Hokkaido Hospital

Hokkaido, , Japan

National Hospital Organization Kanazawa Medical Center

Ishikawa, , Japan

Sakaide City Hospital

Kagawa, , Japan

Tenyoukai Central Hospital

Kagoshima, , Japan

Kawasaki Rinko General Hospital

Kanagawa, , Japan

Matsuba Clinic

Kanagawa, , Japan

Maekawa Medical 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

NHO Kumamoto Saishun Medical Center

Kumamoto, , Japan

Sakura Jyuji Hospital, Sakurajyuji Medical Corporation

Kumamoto, , Japan

Minami Nagano Clinic

Nagano, , Japan

Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital

Nagasaki, , Japan

Ikoma City Hospital

Nara, , Japan

Nagaoka Chuo General Hospital

Niigata, , Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, , Japan

Okayama University Hospital

Okayama, , Japan

Tazuke Kofukai Medical Research Institute, Kitano Hospital

Osaka, , Japan

Japan Community Health care Organization Osaka Minato Central Hospital

Osaka, , Japan

Rinku General Medical Center

Osaka, , Japan

Omi Medical Center

Shiga, , Japan

Kuramochi Clinic Interpark

Tochigi, , Japan

Tokyo center clinic

Tokyo, , Japan

Tokyo Saiseikai Central Hospital

Tokyo, , Japan

Kitasato University Kitasato Institute Hospital

Tokyo, , Japan

Sumida General Clinic

Tokyo, , Japan

Edogawa Hospital

Tokyo, , Japan

Koto Hospital

Tokyo, , Japan

Mishuku Hospital

Tokyo, , Japan

Shimamura Memorial 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

Srinagarind Hospital

Khon Kaen, , Thailand

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, , Thailand

Ratchaburi Hospital

Ratchaburi Provinc, , Thailand

Countries

Japan; Thailand

References

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.

Reference Type: RESULT

PMID: 38154616 (View on PubMed)

Other Identifiers

K-237-01

Identifier Type: -

Identifier Source: org_study_id