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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.

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
Covid19 Drug: K-237 0.3-0.4mg/kg (once daily) Drug: Placebo 0.3-0.4mg/kg (once daily) Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : October 22, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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 Name: 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




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056883


Locations
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Sponsors and Collaborators
Kowa Company, Ltd.
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Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT05056883    
Other Study ID Numbers: K-237-01
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents