Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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 (main population). In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir (5-, 10-, or 15-days) in an additional population with a rebound in COVID-19 within 14 days following completion of an initial 5-day treatment course of nirmatrelvir/ritonavir (population with rebound). 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.

Official Title

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED

Keywords

COVID-19, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), Paxlovid, Nirmatrelvir, Immunocompromised, Ritonavir, Nirmatrelvir plus ritonavir for 5 days, Nirmatrelvir plus ritonavir for 10 days, Nirmatrelvir plus ritonavir for 15 days

Eligibility

You can join if…

Open to people ages 12 years and up

  • Participants aged 12 years or older and weighing ≥40 kg at screening.
  • Confirmed SARS-CoV-2 infection
  • Immunocompromised
  • ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

In addition, the following inclusion criteria only apply to the additional population with rebound:

  • Presenting with documented, symptomatic, COVID-19 rebound within 14 days following completion of an initial 5-day treatment course with nirmatrelvir/ritonavir

You CAN'T join 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

Locations

  • CRS Outpatient Services UCSF not yet accepting patients
    San Francisco California 94143 United States
  • UCSF Helen Diller Medical Center at Parnassus Heights not yet accepting patients
    San Francisco California 94143 United States
  • UCSf infectious disease Lab not yet accepting patients
    San Francisco California 94143 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05438602
Phase
Phase 2 COVID-19 Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated