Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who ha...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05438602
Start Date
August 3 2022
End Date
November 13 2023
Last Update
September 23 2024
Active Locations (84)
Enter a location and click search to find clinical trials sorted by distance.
1
CRS Outpatient Services UCSF
San Francisco, California, United States, 94143
2
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States, 94143
3
UCSf infectious disease Lab
San Francisco, California, United States, 94143
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007