Overview

A Study to Learn About the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With COVID-19 Who Are Immunocompromised

Status:
Not yet recruiting
Trial end date:
2023-11-12
Target enrollment:
0
Participant gender:
All
Summary
Patients with COVID-19 who are immunocompromised have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The purpose of the clinical trial is to evaluate the efficacy (how well a study treatment works in the clinical trial) and safety when taking the study medicine for either 5, 10, or 15 days. All the study medication will be taken by mouth. The first dose of study medication is taken at the study site and the rest at home. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study site at least 10 times during the study.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Ritonavir
Criteria
Inclusion Criteria:

- Confirmed SARS-CoV-2 infection

- Immunocompromised

- Onset of signs/symptoms attributable to the current COVID-19 infection within 5 days
prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day
of randomization.

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