A Study to Learn About the Study Medicines Called Nirmatrelvir/Ritonavir in People at Least 12 Years of Age With COVID-19 Who Are Immunocompromised

Phase 1

• Conditions: SARS-CoV-2 Infection; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-001362-35-HU
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-25
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Participants aged 12 years or older and weighing =40 kg at screening.
- Refer to protocol for reproductive criteria for female participants.
2. 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.
3. =1 signs/symptoms attributable to COVID-19 present on the day of randomization.
4. Immunocompromised.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
2. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class C, or acute liver failure.
3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
6. Receiving dialysis or have known age-specific eGFR or eCrCl <30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device.
7. Oxygen saturation of <92% on room air obtained at rest within 24h prior to randomization.
8. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
9. Current use of any prohibited concomitant medication(s).
10. Current or previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
11. Prior participation in this trial.
12. Females who are pregnant up to <14 weeks gestation. Pregnancy =14 weeks is not exclusionary.
13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified