A Phase III Confirmatory Study of K-237-A Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients with mild COVID-19
Patients 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.
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 investigational 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 with suspected complications of infectious diseases other than COVID-19
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.
Patients undergoing dialysis treatment
Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
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)
Patients requiring oxygen therapy
Patients wno have complications of methemoglobinemia or other diseases that may cause measurement errors in the pulse oximeter
20歳 以上
20age old over
上限なし
No limit
男性・女性
Both
SARS-CoV-2による感染症
COVID-19
あり
K-237 0.3-0.4mg/kg：1日1回経口投与 プラセボ群：1日1回経口投与
K-237 0.3-0.4mg/kg group: oral doses once daily Placebo group: oral doses once daily
治験薬投与開始から168時間までの臨床症状が改善傾向に至るまでの時間
Time from the start of study drug administration to 168 hours before the clinical symptoms started to improve
