COVID-19
Conditions
Interventions
Part1: 6 subjects
Take EFE twice a day, after waking up and before bed, with 150 mL of water for 14 days
Part2: 150 subjects
Take EFE or placebo twice a day, after waking up and before bed, with 150
Sponsors
Odaguchi Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects who can obtain written consent, based on their free intention (2) Subjects whose age at the time of obtaining consent is 20 years or older and under 80 years (3) Subjects who are SARS-CoV-2 positive by PCR or antigen test within 3 days before baseline-test (4) Subjects whose COVID-19 symptoms (upper respiratory tract inflammation such as fever and cough) appiered within 7 days before baseline-test and mild (Resting SpO2 96% or more) (5) Subjects who were judged no problem by the investigator to participate in this clinical trial based on medical examination, vital signs, laboratory test values, chest X-ray, etc.
Exclusion criteria
Exclusion criteria: (1) Subjects who participated in other clinical studies and clinical trials within 12 weeks before the start of study drug administration. And subjects who are planning to participate in clinical studies and clinical trials of unapproved drugs during this study period. (2) Subjects who administered therapeutic medication for COVID-19 within 7 days before the start of study drug administration. (3) Subjects without symptoms due to COVID-19 (upper respiratory tract inflammation such as fever and cough) (4) Subjects whose infection episode is recurrence or reinfection of SARS-CoV-2 (5)Subjects who cannot interrupt the administration of prohibited drugs specified in the clinical trial protocol during the study period (6)Subjects with SpO2 less than 96% without oxygen therapy (7) Subjects with serious or uncontrolled underlying disease, e.g. chronic obstructive pulmonary disease, chronic kidney disease, hepatic dysfunction, diabetes mellitus, hypertension, cardiovascular disease, malignant tumor, body mass index; BMI 30 or higher obesity (not excluded if the disease are mild and controlled) (8) Subjects with impaired consciousness such as the disorientation (9) Subjects with hypersensitivity to Ephedra Herb or Kampo medicines containing Ephedra Herb (10)Pregnant women, subjects who are breastfeeding or may be pregnant (11) In the case the subject is women who can pregnant, whose pregnancy test is positive For both men and women, subjects who do not agree to perform contraception during the clinical trial. (12) Subjects with pacemakers (13) Subjects who have cohabitant participating or have participated in this clinical trial. (14) Subjects who judged by the investigators to be ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-severity rate at Day 15 (Rate of subjects who completed the study without becoming moderate or higher) Part 2 will start, after comfirmation that "adverse events which is causally related to the investigational drug, with Grade 3 or higher based on CTCAE," would not find during the study period (until Day 21) . | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) SARS-CoV-2 negative rate at Day 15 (PCR test) (2) Frequency of use of antipyretic analgesics, antitussives and sputum (3) Number of days until the body temperature decreased less than 37.0 degrees twice in succession without using antipyretic analgesics (4) Improvement score of questionnaire (Face Scale : FS) regarding symptom / pain symptom (5) Number of days until symptoms / pain symptom becomes 0 or 1 in the FS (6) Non-severity rate at Day 21 (Rate of subjects who completed the study without becoming moderate or higher) (7) Rate of subjects who did not become severely at Day 15 and 21 (8) Change of "Medical condition score by 6-point ordinal scale" at Day7, 15 / at the time of discontinuation, Day21 / one week after discontinuation | — |
Contacts
Public ContactMariko Sekine
Kitasato University
Outcome results
None listed