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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT05736861
Eligibility Criteria:
Inclusion Criteria:
* Completed Informed Consent
* Age ≥ 30 years old
* Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
* Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:
* Prior diagnosis of COVID-19 infection (\> 10 days from screening)
* Current or recent (within 10 days of screening) hospitalization
* Current use of study drug or study drug/device combination\*
* Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo\*
* Known contraindication(s) to study drug including prohibited concomitant medications\*
\[If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.\]
Arm-specific exclusion criteria:
* End-stage renal disease on renal replacement therapy
* Liver failure or decompensated cirrhosis
* Use of warfarin, CYP3A4, P-gp inhibitor drugs, or CYP3A4 substrates
* Nursing mothers
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT05736861
Study Brief:
Protocol Section:
NCT05736861