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:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT04411433
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged between 18 to 70 years,
* Patients with symptoms and complaints consistent with possible or confirmed COVID- 19 observed within the last 5 days,
* Patients with uncomplicated possible or confirmed COVID-19:
1. Symptoms such as fever, muscle aches, joint pain, cough, sore throat, nasal congestion, however no respiratory distress, no tachypnea or no SpO2 \< 93%,
2. Chest imaging (X-ray or CT chest) documented as normal
* Patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms):
1. Symptoms such as fever, muscle aches, joint pain, cough, sore throat, nasal congestion, as well as respiratory rate \<30/min and SpO2 above 93% on room air,
2. Chest imaging (X-ray or CT chest)-documented mild pneumonia symptoms
* Patients who were decided to isolate and treat because of COVID-19 in the hospital,
* Patients who have not been involved in any other interventional studies.
Exclusion Criteria:
* Patients considered as inappropriate for this study for any reason like noncompliance by the researcher,
* Patients with persisting refractory nausea, vomiting, chronic diarrhoea or chronic gastrointestinal disorders, inability to swallow the study drug which may affect adequate absorption,
* Patients with chronic liver disease: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the upper limit of normal (ULN),
* Patients with gout or hyperuricemia (above the ULN),
* Patients with severe pneumonia symptoms,
* Patients with known allergy to Favipiravir or for substances used in the study,
* Patients did not receive specific antiviral drugs such as lopinavir/ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission.
* Patients with known chronic renal impairment/failure \[creatinine clearance (CcCl) \<30 mL/min\],
* Pregnant and lactating women
* Patients undergoing cardiac ablation therapy
* Patients using antiarrhythmic drugs
* Patients actively receiving chemotherapy
* Acute immunosuppressed patients
* Patients undergoing psychosis therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04411433
Study Brief:
Protocol Section:
NCT04411433