A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: * Have completed treatment with nirmatrelvir/ritonavir * Have a rebound in COVID-19 symptoms * Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.

Key facts

Study ID

NCT05567952

Run by

Pfizer

People needed

436

Starts

2022-10-19

Expected to finish

2024-02-09

Last updated by the study team

2024-10-08

Who can join

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

You may qualify if…

• Documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. Symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
• Onset of rebound in COVID-19 symptoms within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
• Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and ≥1 sign/symptom attributable to COVID-19 present on the day of randomization.
• SARS-CoV-2 infection as determined by rapid antigen testing within 24 hours prior to randomization
• At least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

You may not qualify if…

• Current need for hospitalization, hospitalized for the COVID-19 infection or anticipated need for hospitalization within 24 hours after randomization
• History of severe chronic liver disease
• 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
• Immunocompromised.
• Current use of any prohibited concomitant medication(s)
• Females who are pregnant and <14 weeks gestation

Where it is running

• Abby's Research institute — Phoenix, Arizona, United States
• Epic Medical Research - Surprise — Surprise, Arizona, United States
• Smart Cures Clinical Research — Anaheim, California, United States
• Hope Clinical Research, Inc. — Canoga Park, California, United States
• Ascada Health PC dba Ascada Research — Fullerton, California, United States
• Ascada Research — Fullerton, California, United States
• Paradigm Clinical Research Centers, Inc — La Mesa, California, United States
• CVS Health - 8876 - Long Beach — Long Beach, California, United States
• Carbon Health - North Hollywood - NoHo West — North Hollywood, California, United States
• Paradigm Clinical Research Centers, Inc — Wheat Ridge, Colorado, United States
• Emerson Clinical Research Institute - Washington - Connecticut Avenue — Washington D.C., District of Columbia, United States
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research — Brandon, Florida, United States
• Herco Medical and Research Center Inc — Coral Gables, Florida, United States
• NeoClinical Research — Hialeah, Florida, United States
• Sweet Hope Research Specialty, Inc — Hialeah, Florida, United States
• Medical Trust Clinics — Oshawa, Ontario, Canada
• Unlimited Medical Research Group LLC — Hialeah Gardens, Florida, United States
• Asclepes Research Center - Spring Hill — Lutz, Florida, United States
• LCC Medical Research Institute — Miami, Florida, United States
• Premium Medical Research Corp — Miami, Florida, United States
• Global Health Clinical Trials — Miami, Florida, United States
• South Florida Research Center — Miami, Florida, United States
• Reliant Medical Research — Miami, Florida, United States
• The Institute for Liver Health dba Arizona Clinical Trials — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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