A Phase III Confirmatory Study of K-237

JRCT ID: jRCT2031210316

Registered date:16/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 22/10/2021
• Target sample size: 1000
• Countries of recruitment: Thailand,Japan
• Study type: Interventional

Intervention(s)

K-237 0.3-0.4mg/kg group: oral doses once daily
Placebo group: oral doses once daily

Outcome(s)

• Primary Outcome: Time from the start of study drug administration to 168 hours before the clinical symptoms started to improve

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be eligible for this study.
(1) Males and females who are 12 years of age or older at the time of obtaining consent
(2) Patients 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) 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.

Exclude 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 investigational 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 with suspected complications of infectious diseases other than COVID-19
(5) 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.
(6) Patients undergoing dialysis treatment
(7) Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
(8) Patients wno have complications of poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or more or diastolic blood pressure (DBP) of 110 mmHg or more)
(9) Patients requiring oxygen therapy
(10) Patients wno have complications of methemoglobinemia or other diseases that may cause measurement errors in the pulse oximeter

Related Information

• Primary Sponsor: Tanigawa Ryohei