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A Phase III Confirmatory Study of K-237

Sponsor
Kowa Company, Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05056883
Collaborator
(none)
1,030
Enrollment
55
Locations
2
Arms
14.3
Anticipated Duration (Months)
18.7
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: K-237 0.3-0.4mg/kg (once daily)
  • Drug: Placebo 0.3-0.4mg/kg (once daily)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1030 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

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

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

    		•
    Placebo Comparator: Control A

    Placebo (once daily)

    Drug: Placebo 0.3-0.4mg/kg (once daily)
    Placebo 3mg tablet

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal [Day1～11 after administration]

    2. Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen) [Day1～11 after administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hosokawa Surgical Clinic Aichi Japan 453-0812
    2 Nagoya City University West Medical Center Aichi Japan 462-8508
    3 Nagoya City University East Medical Center Aichi Japan 464-8547
    4 Naika Tonyobyonaika Maejima Iin Aichi Japan 466-0013
    5 Nagoya City University Hospital Aichi Japan 467-8602
    6 Tohno Chuo Clinic Aichi Japan 509-6134
    7 Kamagaya General Hospital Chiba Japan 273-0121
    8 Japan Community Health care Organization Funabashi Central Hospital Chiba Japan 273-8556
    9 International University of Health and Welfare Narita Hospital Chiba Japan 286-8520
    10 National Hospital Organization Fukuokahigashi Medical Center Fukuoka Japan 811-3195
    11 Fukuoka Kinen Hospital Fukuoka Japan 814-8525
    12 National Hospital Organization Takasaki General Medical Center Gunma Japan 370-0829
    13 Hiroshima Prefectural Hospital Hiroshima Japan 734-8530
    14 Japan Community Health care Organization Hokkaido Hospital Hokkaido Japan 062-8618
    15 National Hospital Organization Kanazawa Medical Center Ishikawa Japan 920-8650
    16 Sakaide City Hospital Kagawa Japan 762-8550
    17 Tenyoukai Central Hospital Kagoshima Japan 892-0822
    18 Kawasaki Rinko General Hospital Kanagawa Japan 210-0806
    19 Matsuba Clinic Kanagawa Japan 212-0024
    20 Maekawa Medical Clinic Kanagawa Japan 220-0004
    21 Tsuzuki Azuma Clinic Primary care and Rheumatology Kanagawa Japan 224-0041
    22 Mutsukawa Clinic Primary care and Gastroenterology Kanagawa Japan 232-0066
    23 Kitasato University Hospital Kanagawa Japan 252-0375
    24 NHO Kumamoto Saishun Medical Center Kumamoto Japan 861-1196
    25 Sakura Jyuji Hospital, Sakurajyuji Medical Corporation Kumamoto Japan 861-4173
    26 Minami Nagano Clinic Nagano Japan 381-2217
    27 Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital Nagasaki Japan 857-0134
    28 Ikoma City Hospital Nara Japan 630-0213
    29 Nagaoka Chuo General Hospital Niigata Japan 940-0861
    30 Okayama City General Medical Center Okayama City Hospital Okayama Japan 700-8557
    31 Okayama University Hospital Okayama Japan 700-8558
    32 Tazuke Kofukai Medical Research Institute, Kitano Hospital Osaka Japan 530-8480
    33 Japan Community Health care Organization Osaka Minato Central Hospital Osaka Japan 552-0003
    34 Rinku General Medical Center Osaka Japan 598-8577
    35 Omi Medical Center Shiga Japan 525-8585
    36 Kuramochi Clinic Interpark Tochigi Japan 321-0114
    37 Tokyo center clinic Tokyo Japan 103-0028
    38 Tokyo Saiseikai Central Hospital Tokyo Japan 108-0073
    39 Kitasato University Kitasato Institute Hospital Tokyo Japan 108-8642
    40 Sumida General Clinic Tokyo Japan 130-0012
    41 Edogawa Hospital Tokyo Japan 133-0052
    42 Koto Hospital Tokyo Japan 136-0072
    43 Mishuku Hospital Tokyo Japan 153-0051
    44 Shimamura Memorial Hospital Tokyo Japan 177-0051
    45 Minamino Cardiovascular Hospital Tokyo Japan 192-0918
    46 Tokyo Medical University Hachioji Medical Center Tokyo Japan 193-0998
    47 Ome Municipal General Hospital Tokyo Japan 198-0042
    48 Toyama University Hospital Toyama Japan 930-0194
    49 Japan Organization of Occupational Health and Safety Toyama Rosai Hospital Toyama Japan 937-0042
    50 Toyama City Hospital Toyama Japan 939-8511
    51 Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital Wakayama Japan 640-8505
    52 National Hospital Organization Minami Wakayama Medical Center Wakayama Japan 646-8558
    53 Srinagarind Hospital Khon Kaen Thailand 40002
    54 Bamrasnaradura Infectious Diseases Institute Nonthaburi Thailand 11000
    55 Ratchaburi Hospital Ratchaburi Provinc Thailand 70000

    Sponsors and Collaborators

    • Kowa Company, Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kowa Company, Ltd.
    ClinicalTrials.gov Identifier:
    NCT05056883
    Other Study ID Numbers:
    • K-237-01
    First Posted:
    Sep 27, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Ivermectin

    Study Results

    No Results Posted as of Aug 9, 2022