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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05438602

Run by

Pfizer

People needed

158

Starts

2022-08-03

Expected to finish

2023-11-13

Last updated by the study team

2024-09-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify 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

Where it is running

• INTERMED Groupe Sante — Chicoutimi, Quebec, Canada
• CRS Outpatient Services UCSF — San Francisco, California, United States
• UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States
• UCSf infectious disease Lab — San Francisco, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• I.V.A.M. Clinical & Investigational Center — Doral, Florida, United States
• Qway Research LLC — Hialeah, Florida, United States
• Premium Medical Research Corp — Miami, Florida, United States
• Global Health Clinical Trials — Miami, Florida, United States
• I.V.A.M. Clinical & Investigational Center — Miami, Florida, United States
• NAPA Research — Pompano Beach, Florida, United States
• Santos Research Center — Tampa, Florida, United States
• Emory University Hospital-Georgia Clinical Research Center — Atlanta, Georgia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• National Institute of Health — Bethesda, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Beaumont Infectious Diseases Research — Royal Oak, Michigan, United States
• Revival Research Institute — Sterling Heights, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• South Texas Clinical Research — Corpus Christi, Texas, United States
• Baylor University Medical Center — Dallas, Texas, United States
• North Texas Infectious Diseases Consultants, P.A — Dallas, Texas, United States
• Winchester District Memorial Hospital — Winchester, Ontario, Canada

Full record on ClinicalTrials.gov

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