JPRN-jRCT2031210063
Active, not recruiting
Phase 1
The exploratory study investigating the efficacy and safety of Ephedrine alkaloids-free Ephedra Herb extract (EFE) in patients with COVID-19 in the early stages of infection- Double-blind, randomized, multicenter Phase I / II controlled trial
Odaguchi Hiroshi0 sites156 target enrollmentApril 30, 2021
ConditionsCOVID-19
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Odaguchi Hiroshi
- Enrollment
- 156
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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