NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210316

Registered date:16/09/2021

A Phase III Confirmatory Study of K-237

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedCOVID-19
Date of first enrollment22/10/2021
Target sample size1000
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)K-237 0.3-0.4mg/kg group: oral doses once daily Placebo group: oral doses once daily

Outcome(s)

Primary OutcomeTime from the start of study drug administration to 168 hours before the clinical symptoms started to improve
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who meet all of the following criteria will be eligible for this study. (1) Males and females who are 20 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 72 hours prior to obtaining consent. (3) Patients with fever symptoms of 37.5 degrees Celsius or higher at the time of the screening test. (4) Patients who have at least one symptom of muscle pain, sore throat, diarrhea, nausea, vomiting, cough, or shortness of breath with a score of 2 or higher at the time of the screening test. (5) Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.
Exclude criteriaSubjects 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) Patients whose body weight at the time of screening test is less than 25 kg or 127 kg or more, and the first decimal place of body weight shall be rounded off. (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

Contact

Public contact
Name Contact for clinical trial information -
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7454
E-mail ctrdinfo@kowa.co.jp
Affiliation Kowa Company, Ltd.
Scientific contact
Name Takashi Narusawa
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7454
E-mail ctrdinfo@kowa.co.jp
Affiliation Kowa Company, Ltd.