A Phase III Confirmatory Study of K-237

May 16, 2024 updated by: Kowa Company, Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1030

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 467-8602
        • Nagoya City University Hospital
      • Aichi, Japan, 453-0812
        • Hosokawa Surgical Clinic
      • Aichi, Japan, 462-8508
        • Nagoya City University West Medical Center
      • Aichi, Japan, 464-8547
        • Nagoya City University East Medical Center
      • Aichi, Japan, 466-0013
        • Naika Tonyobyonaika Maejima Iin
      • Aichi, Japan, 509-6134
        • Tohno Chuo Clinic
      • Chiba, Japan, 273-0121
        • Kamagaya General Hospital
      • Chiba, Japan, 273-8556
        • Japan Community Health care Organization Funabashi Central Hospital
      • Chiba, Japan, 286-8520
        • International University of Health and Welfare Narita Hospital
      • Fukuoka, Japan, 814-8525
        • Fukuoka Kinen Hospital
      • Fukuoka, Japan, 811-3195
        • National Hospital Organization Fukuokahigashi Medical Center
      • Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
      • Hiroshima, Japan, 734-8530
        • Hiroshima Prefectural Hospital
      • Hokkaido, Japan, 062-8618
        • Japan Community Health Care Organization Hokkaido Hospital
      • Ishikawa, Japan, 920-8650
        • National Hospital Organization Kanazawa Medical Center
      • Kagawa, Japan, 762-8550
        • Sakaide City Hospital
      • Kagoshima, Japan, 892-0822
        • Tenyoukai Central Hospital
      • Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Japan, 210-0806
        • Kawasaki Rinko General Hospital
      • Kanagawa, Japan, 212-0024
        • Matsuba Clinic
      • Kanagawa, Japan, 220-0004
        • Maekawa Medical Clinic
      • Kanagawa, Japan, 224-0041
        • Tsuzuki Azuma Clinic Primary care and Rheumatology
      • Kanagawa, Japan, 232-0066
        • Mutsukawa Clinic Primary care and Gastroenterology
      • Kumamoto, Japan, 861-1196
        • NHO Kumamoto Saishun Medical Center
      • Kumamoto, Japan, 861-4173
        • Sakura Jyuji Hospital, Sakurajyuji Medical Corporation
      • Nagano, Japan, 381-2217
        • Minami Nagano Clinic
      • Nagasaki, Japan, 857-0134
        • Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital
      • Nara, Japan, 630-0213
        • Ikoma City Hospital
      • Niigata, Japan, 940-0861
        • Nagaoka Chuo General Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okayama, Japan, 700-8557
        • Okayama City General Medical Center Okayama City Hospital
      • Osaka, Japan, 598-8577
        • Rinku General Medical Center
      • Osaka, Japan, 530-8480
        • Tazuke Kofukai Medical Research Institute, Kitano Hospital
      • Osaka, Japan, 552-0003
        • Japan Community Health care Organization Osaka Minato Central Hospital
      • Shiga, Japan, 525-8585
        • Omi Medical Center
      • Tochigi, Japan, 321-0114
        • Kuramochi Clinic Interpark
      • Tokyo, Japan, 193-0998
        • Tokyo Medical University Hachioji Medical Center
      • Tokyo, Japan, 153-0051
        • Mishuku Hospital
      • Tokyo, Japan, 103-0028
        • Tokyo Center Clinic
      • Tokyo, Japan, 108-0073
        • Tokyo Saiseikai Central Hospital
      • Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Tokyo, Japan, 130-0012
        • Sumida General Clinic
      • Tokyo, Japan, 133-0052
        • Edogawa Hospital
      • Tokyo, Japan, 136-0072
        • Koto Hospital
      • Tokyo, Japan, 177-0051
        • Shimamura Memorial Hospital
      • Tokyo, Japan, 192-0918
        • Minamino Cardiovascular Hospital
      • Tokyo, Japan, 198-0042
        • Ome Municipal General Hospital
      • Toyama, Japan, 930-0194
        • Toyama University Hospital
      • Toyama, Japan, 937-0042
        • Japan Organization of Occupational Health and Safety Toyama Rosai Hospital
      • Toyama, Japan, 939-8511
        • Toyama City Hospital
      • Wakayama, Japan, 640-8505
        • Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital
      • Wakayama, Japan, 646-8558
        • National Hospital Organization Minami Wakayama Medical Center
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Infectious Diseases Institute
      • Ratchaburi Provinc, Thailand, 70000
        • Ratchaburi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend
Time Frame: Day1～11 after administration
Day1～11 after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal
Time Frame: Day1～11 after administration
Day1～11 after administration
Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen)
Time Frame: Day1～11 after administration
Day1～11 after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kowa Company, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-237-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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