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Covid19Phase 3NCT05056883

A Phase III Confirmatory Study of K-237

A Phase 3 study testing K-237 0.3-0.4mg/kg (once daily) in people with Covid19, run by Kowa Company, Ltd. at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Covid19
What is being tested?
K-237 0.3-0.4mg/kg (once daily)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,030 participants
Where
55 sitesin 2 countries
Study dates
22 Oct 2021to 26 Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

Japan52 sites

  • Hosokawa Surgical Clinic

    Aichi, 453-0812

  • Nagoya City University West Medical Center

    Aichi, 462-8508

  • Nagoya City University East Medical Center

    Aichi, 464-8547

  • Naika Tonyobyonaika Maejima Iin

    Aichi, 466-0013

  • Nagoya City University Hospital

    Aichi, 467-8602

  • Tohno Chuo Clinic

    Aichi, 509-6134

  • Kamagaya General Hospital

    Chiba, 273-0121

  • Japan Community Health care Organization Funabashi Central Hospital

    Chiba, 273-8556

  • International University of Health and Welfare Narita Hospital

    Chiba, 286-8520

  • National Hospital Organization Fukuokahigashi Medical Center

    Fukuoka, 811-3195

  • Fukuoka Kinen Hospital

    Fukuoka, 814-8525

  • National Hospital Organization Takasaki General Medical Center

    Gunma, 370-0829

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Japan Community Health care Organization Hokkaido Hospital

    Hokkaido, 062-8618

  • National Hospital Organization Kanazawa Medical Center

    Ishikawa, 920-8650

  • Sakaide City Hospital

    Kagawa, 762-8550

  • Tenyoukai Central Hospital

    Kagoshima, 892-0822

  • Kawasaki Rinko General Hospital

    Kanagawa, 210-0806

  • Matsuba Clinic

    Kanagawa, 212-0024

  • Maekawa Medical Clinic

    Kanagawa, 220-0004

  • Tsuzuki Azuma Clinic Primary care and Rheumatology

    Kanagawa, 224-0041

  • Mutsukawa Clinic Primary care and Gastroenterology

    Kanagawa, 232-0066

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • NHO Kumamoto Saishun Medical Center

    Kumamoto, 861-1196

  • Sakura Jyuji Hospital, Sakurajyuji Medical Corporation

    Kumamoto, 861-4173

  • Minami Nagano Clinic

    Nagano, 381-2217

  • Japan Organization of Occupational Health and Safety Nagasaki Rosai Hospital

    Nagasaki, 857-0134

  • Ikoma City Hospital

    Nara, 630-0213

  • Nagaoka Chuo General Hospital

    Niigata, 940-0861

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557

  • Okayama University Hospital

    Okayama, 700-8558

  • Tazuke Kofukai Medical Research Institute, Kitano Hospital

    Osaka, 530-8480

  • Japan Community Health care Organization Osaka Minato Central Hospital

    Osaka, 552-0003

  • Rinku General Medical Center

    Osaka, 598-8577

  • Omi Medical Center

    Shiga, 525-8585

  • Kuramochi Clinic Interpark

    Tochigi, 321-0114

  • Tokyo center clinic

    Tokyo, 103-0028

  • Tokyo Saiseikai Central Hospital

    Tokyo, 108-0073

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642

  • Sumida General Clinic

    Tokyo, 130-0012

  • Edogawa Hospital

    Tokyo, 133-0052

  • Koto Hospital

    Tokyo, 136-0072

  • Mishuku Hospital

    Tokyo, 153-0051

  • Shimamura Memorial Hospital

    Tokyo, 177-0051

  • Minamino Cardiovascular Hospital

    Tokyo, 192-0918

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

  • Ome Municipal General Hospital

    Tokyo, 198-0042

  • Toyama University Hospital

    Toyama, 930-0194

  • Japan Organization of Occupational Health and Safety Toyama Rosai Hospital

    Toyama, 937-0042

  • Toyama City Hospital

    Toyama, 939-8511

  • Japan Organization of Occupational Health and Safety Wakayama Rosai Hospital

    Wakayama, 640-8505

  • National Hospital Organization Minami Wakayama Medical Center

    Wakayama, 646-8558

Other trials in Japan

Thailand3 sites

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, 11000

  • Ratchaburi Hospital

    Ratchaburi Provinc, 70000

Other trials in Thailand

About this study

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

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.

Conditions
Covid19
Being tested
K-237 0.3-0.4mg/kg (once daily), Placebo 0.3-0.4mg/kg (once daily)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • K-237 0.3-0.4mg/kg (once daily)Drug

    Also called Ivermectin 0.3-0.4mg/kg (once daily)

    Ivermectin 3mg tablet

  • Placebo 0.3-0.4mg/kg (once daily)Drug

    Placebo 3mg tablet

Study groups in NCT05056883
Study groupRoleWhat they receive
Treatment AExperimentalK-237 0.3-0.4mg/kg (once daily)
Receives: Drug: K-237 0.3-0.4mg/kg (once daily)
Control APlacebo comparatorPlacebo (once daily)
Receives: Drug: Placebo 0.3-0.4mg/kg (once daily)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend

    Measured: Day1～11 after administration

Secondary outcomes (2)

  1. In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal

    Measured: Day1～11 after administration

  2. Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen)

    Measured: Day1～11 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start22 Oct 2021
  3. Primary completion26 Aug 2022
  4. Study completion26 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,030 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056883
Sponsor's protocol ID
K-237-01
Status last verified
May 2024
First submitted
15 Sep 2021
Last updated
20 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mikamo H, Takahashi S, Yamagishi Y, Hirakawa A, Harada T, Nagashima H, Noguchi C, Masuko K, Maekawa H, Kashii T, Ohbayashi H, Hosokawa S, Maejima K, Yamato M, Manosuthi W, Paiboonpol S, Suganami H, Tanigawa R, Kawamura H; IVERMILCO Study Group. Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand. J Infect Chemother. 2024 Jun;30(6):536-543. doi: 10.1016/j.jiac.2023.12.012. Epub 2023 Dec 27.

    PubMed 38154616

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-237 0.3-0.4mg/kg (once daily) in people with Covid19, run by Kowa Company, Ltd. at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Japan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05056883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.

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