Not currently recruiting at UCSF

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

a study on COVID-19

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen.

The study is seeking participants who:

  • Have a confirmed COVID-19 infection
  • Are Immunocompromised
  • Experience 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.

In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir.

For this group, the study is seeking participants who:

  • Have a confirmed COVID-19 infection
  • Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
  • The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir
  • Are Immunocompromised
  • Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected 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

(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.

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