A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
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Keep this study
Lead
Pfizer
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
