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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT05438602
Eligibility Criteria:
Inclusion Criteria (applicable for both the main population and population with rebound):
* Participants aged 12 years or older and weighing ≥40 kg at screening.
* Immunocompromised
* ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.
Participants for the main population must have:
\- Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected within 5 days prior to randomization for the main study population.
Participants form the rebound population must have:
\- Confirmed SARS-CoV-2 infection as determined by RT-PCR or rapid antigen testing in any specimen collected within 24h prior to randomization and collected within 14 days after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir for the population with rebound.
Exclusion Criteria:
* Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization
* Known medical history of active liver disease
* Known HIV infection with a viral load \>400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV)
* Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) \<30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device
* Oxygen saturation of \<92% on room air obtained at rest within 24 hours prior to randomization
* Current use of any prohibited concomitant medication(s)
* Females who are pregnant and \<14 weeks gestation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05438602
Study Brief:
Protocol Section:
NCT05438602