A Phase III Confirmatory Study of K-237

Covid19 Clinical Trial

Official title:

A Phase III Confirmatory Study of K-237-Multi-regional, Multi-center, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Mild COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05056883
• Other study ID #: K-237-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 22, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1030
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• K-237 0.3-0.4mg/kg (once daily)
Ivermectin 3mg tablet
• Placebo 0.3-0.4mg/kg (once daily)
Placebo 3mg tablet

Locations

Country	Name	City	State
Japan	Hosokawa Surgical Clinic	Aichi
Japan	Nagoya City University East Medical Center	Aichi
Japan	Nagoya City University Hospital	Aichi
Japan	Nagoya City University West Medical Center	Aichi
Japan	Naika Tonyobyonaika Maejima Iin	Aichi
Japan	Tohno Chuo Clinic	Aichi
Japan	International University of Health and Welfare Narita Hospital	Chiba
Japan	Japan Community Health care Organization Funabashi Central Hospital	Chiba
Japan	Kamagaya General Hospital	Chiba
Japan	Fukuoka Kinen Hospital	Fukuoka
Japan	National Hospital Organization Fukuokahigashi Medical Center	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	Kitasato University Hospital	Kanagawa
Japan	Maekawa Medical Clinic	Kanagawa
Japan	Matsuba Clinic	Kanagawa
Japan	Mutsukawa Clinic Primary care and Gastroenterology	Kanagawa
Japan	Tsuzuki Azuma Clinic Primary care and Rheumatology	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	Japan Community Health care Organization Osaka Minato Central Hospital	Osaka
Japan	Rinku General Medical Center	Osaka
Japan	Tazuke Kofukai Medical Research Institute, Kitano Hospital	Osaka
Japan	Omi Medical Center	Shiga
Japan	Kuramochi Clinic Interpark	Tochigi
Japan	Edogawa Hospital	Tokyo
Japan	Kitasato University Kitasato Institute Hospital	Tokyo
Japan	Koto Hospital	Tokyo
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	Mishuku Hospital	Tokyo
Japan	Ome Municipal General Hospital	Tokyo
Japan	Shimamura Memorial Hospital	Tokyo
Japan	Sumida General Clinic	Tokyo
Japan	Tokyo center clinic	Tokyo
Japan	Tokyo Medical University Hachioji Medical Center	Tokyo
Japan	Tokyo Saiseikai Central Hospital	Tokyo
Japan	Japan Organization of Occupational Health and Safety Toyama Rosai Hospital	Toyama
Japan	Toyama City Hospital	Toyama
Japan	Toyama University Hospital	Toyama
Japan	Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital	Wakayama
Japan	National Hospital Organization Minami Wakayama Medical Center	Wakayama
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	Bamrasnaradura Infectious Diseases Institute	Nonthaburi
Thailand	Ratchaburi Hospital	Ratchaburi Provinc

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Countries where clinical trial is conducted

Japan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend		Day1~11 after administration
Secondary	In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal		Day1~11 after administration
Secondary	Time to reach a temperature of less than 37.5 °C without the use of antipyretics (acetaminophen)		Day1~11 after administration