Trial record 1 of 1 for:
COVID-19 | ivermectin | kowa [Lead]
A Phase III Confirmatory Study of K-237
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 27, 2021
Last Update Posted : August 9, 2022
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Sponsor:
Kowa Company, Ltd.
Information provided by (Responsible Party):
Kowa Company, Ltd.
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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 |
| 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
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
Drug Information available for:
Ivermectin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment A
K-237 0.3-0.4mg/kg (once daily)
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Drug: K-237 0.3-0.4mg/kg (once daily)
Ivermectin 3mg tablet
Other Name: Ivermectin 0.3-0.4mg/kg (once daily) |
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Placebo Comparator: Control A
Placebo (once daily)
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Drug: Placebo 0.3-0.4mg/kg (once daily)
Placebo 3mg tablet |
Primary Outcome Measures :
- 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 :
- 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 ]
Information from the National Library of Medicine
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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.
- Males and females who are 12 years of age or older at the time of obtaining consent
- 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.
- 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.
- Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.
Exclusion Criteria:
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Subjects who meet any one of the following criteria will be excluded from this study.
- 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.
- Patients who need to receive concomitant therapy or administration of prohibited drugs during the study period
- 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.
- Patients currently using antiviral drugs
- Patients with suspected complications of infectious diseases other than COVID-19
- Subjects with a history of COVID-19 within 1 month prior to obtaining consent
- 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.
- Patients undergoing dialysis treatment
- Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
- Patients with poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or higher or diastolic blood pressure (DBP) of 110 mmHg or higher)
- Patients with complications of diabetic retinopathy, diabetic nephropathy, or diabetic neuropathy
- Patients with heart failure of NYHA Class III or higher
- Patients with malignant tumors or those judged to have a high possibility of recurrence
- Patients requiring oxygen therapy
- A person who has a complication of methemoglobinemia or any other disease that may cause measurement error of the pulse oximeter
- Patients with a history of serious drug allergy (anaphylactic shock, etc.)
- Pregnant women, lactating women, or women who plan to become pregnant or lactate during the study period
- 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
- Patients who have been administered IVM.
- 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
- 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
Show 55 study locations
Sponsors and Collaborators
Kowa Company, Ltd.
| 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 |
| 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 Ivermectin Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Antiparasitic Agents Anti-Infective Agents |