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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04494204
Eligibility Criteria:
Inclusion Criteria:
* Gender: Either male or non-pregnant, non-lactating female aged \> 18-70
* Patients with RT-PCR confirmed diagnosis of COVID-19
* Patients with mild to moderate COVID-19 infection having either one of the following criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 \> 90% on room air
* Subjects willing to give written informed consent
* Subjects able to take the drug orally and comply with the study protocol
* Women of child bearing potential must have a negative urine pregnancy test prior to study entry
Exclusion Criteria:
* Patients with persistent vomiting
* Critically ill patients
* P/F ratio less than 200 (moderate-severe ARDS)
* Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
* Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
* Patients with altered mental state
* Patients with multiple organ failure requiring ICU monitoring and treatment
* Patients with respiratory failure and requiring mechanical ventilation
* Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subject's participation in the study or interferes with the interpretation of the study results.
* Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
* Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
* Patient who have participated in another investigational study within 3 months prior to enrollment in this study
* Investigators, study personnel, sponsor's representatives and their first-degree relatives.
* Pregnant subjects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04494204
Study Brief:
Protocol Section:
NCT04494204