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History of Changes for Study: NCT05056883
A Phase III Confirmatory Study of K-237
Latest version (submitted August 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 15, 2021 None (earliest Version on record)
2 November 12, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 26, 2022 Study Status, Eligibility and Study Identification
4 February 13, 2022 Study Status, Eligibility and Outcome Measures
5 March 16, 2022 Contacts/Locations and Study Status
6 March 31, 2022 Contacts/Locations and Study Status
7 April 7, 2022 Study Status and Contacts/Locations
8 April 15, 2022 Contacts/Locations and Study Status
9 April 29, 2022 Contacts/Locations and Study Status
10 June 30, 2022 Study Status and Contacts/Locations
11 July 18, 2022 Study Status and Contacts/Locations
12 August 7, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT05056883
Submitted Date:  September 15, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: K-237-01
Brief Title: A Phase III Confirmatory Study of K-237
Official Title: A Phase III Confirmatory Study of K-237-A Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Mild COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2021
Overall Status: Not yet recruiting
Study Start: October 22, 2021
Primary Completion: March 31, 2022 [Anticipated]
Study Completion: March 31, 2022 [Anticipated]
First Submitted: September 15, 2021
First Submitted that
Met QC Criteria:
September 15, 2021
First Posted: September 27, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
September 15, 2021
Last Update Posted: September 27, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Kowa Company, Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Covid19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module 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
[ Time Frame: Day1~14 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
[ Time Frame: Day1~14 after administration ]

2. Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen)
[ Time Frame: Day1~14 after administration ]

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Persons who meet all of the following criteria will be eligible for this clinical trial.
    1. Males and females who are 20 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 72 hours prior to obtaining consent.
    3. Those who have fever symptoms (37.5 degrees Celsius or higher) at the time of screening test.
    4. Patients who have at least one symptom with a score of 2 or higher among the symptoms of myalgia, sore throat, diarrhea, nausea, vomiting, cough, and shortness of breath at the time of the screening test.
    5. Patients with a blood oxygen saturation (SpO2) of 96 % or higher during room air inhalation 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. Patients whose body weight at the time of screening test is less than 25 kg or more than 127 kg (the first decimal place of body weight shall be rounded off)
    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.
Open or close this module Contacts/Locations
Central Contact Person: Yuji Yoshikawa
Telephone: 81-3-3279-7454
Email: ctrdinfo@kowa.co.jp
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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