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A Phase III Confirmatory Study of K-237

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05056883
Recruitment Status : Active, not recruiting
First Posted : September 27, 2021
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Kowa Company, Ltd.

Tracking Information
First Submitted Date  ICMJE September 15, 2021
First Posted Date  ICMJE September 27, 2021
Last Update Posted Date August 9, 2022
Actual Study Start Date  ICMJE October 22, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2022)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend [ Time Frame: Day1~14 after administration ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2022)
  • 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 ]
  • Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen) [ Time Frame: Day1~11 after administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal [ Time Frame: Day1~14 after administration ]
  • Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen) [ Time Frame: Day1~14 after administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Confirmatory Study of K-237
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: K-237 0.3-0.4mg/kg (once daily)
    Ivermectin 3mg tablet
    Other Name: Ivermectin 0.3-0.4mg/kg (once daily)
  • Drug: Placebo 0.3-0.4mg/kg (once daily)
    Placebo 3mg tablet
Study Arms  ICMJE
  • Experimental: Treatment A
    K-237 0.3-0.4mg/kg (once daily)
    Intervention: Drug: K-237 0.3-0.4mg/kg (once daily)
  • Placebo Comparator: Control A
    Placebo (once daily)
    Intervention: Drug: Placebo 0.3-0.4mg/kg (once daily)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 7, 2022)
1030
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2021)
1000
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05056883
Other Study ID Numbers  ICMJE K-237-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kowa Company, Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kowa Company, Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kowa Company, Ltd.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP