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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04445467
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent by the participant or authorized representative
* Age ≥18 years
* Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days
* COVID-19 related symptom initiation within 5 days
* Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
Exclusion Criteria:
* Known allergy to the study medication
* Is on another antiviral for the treatment of COVID-19
* Pregnancy
* Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification
* Patients with renal impairment requiring dialysis
* Is deemed by the Investigator to be ineligible for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04445467
Study Brief:
Protocol Section:
NCT04445467