Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04402203
Eligibility Criteria:
Inclusion Criteria:
1. Age: Male or female patients 18 -65 years old
2. Respiratory samples tested positive for the novel coronavirus.
3. Initial symptoms will within 7 days
4. Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to enrollment)
Exclusion Criteria:
1. Severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (OI) \< 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and/or combined failure of other organs that required ICU monitoring and treatment).
2. Chronic liver and kidney disease and reaching end stage. (Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over 5 times of normal upper range will excluded).
(Normal upper limit of Serum AST = 40 units /L, ALT = 56 units /L)
3. Serum uric acid \>7.0 mg/dL in Male and Serum uric acid \>6.0 mg/dL in Female will excluded
4. ICU patient
5. Previous history of allergic reactions to Favipiravir.
6. Pregnant or lactating women
7. Women of a childbearing age with a positive pregnancy test.
8. Miscarriage, or within 2 weeks after delivery
9. Hypertensive patients, who are taking Calcium Channel Blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04402203
Study Brief:
Protocol Section:
NCT04402203