COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001362-35/SK

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2022-09-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Participants aged 12 years or older and weighing ≥40 kg at screening (Appendix 9, Section 10.9.1). - Refer to Appendix 4 for reproductive criteria for female (Section 10.4.2) participants. 2. Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected as specified in Appendix 9, Section 10.9.2 for the main study population or Appendix, Section 10.9.5 for the additional population with rebound. 3. ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization (Appendix 9, Section 10.9.3). 4. Immunocompromised (Appendix 9, Section 10.9.4). In addition, the followin inclusion criteria only apply to the additional population with rebound. 5. Presenting with documented, symptomatic COVID-19 rebound within 14 days following completion of an initial 5 day treatment course with nirmatrlvir/ritonavir as specified in Appendix 9, section 10.9.5.

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 <30 mL/min/1.73 m2 or CrCl <30mL/min 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.

3

Pfizer Inc.

12

100

Australia;Brazil;Bulgaria;Canada;Hungary;Mexico;Slovakia;Spain;United States

High risk patients

N/A

15

Proportion of participants with sustained NP swab SARS-CoV-2 RNA <LLOQ (defined as <2.0 log10 copies/mL) from Day 15 through Day 44.

Declared number of arm (4.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1123, "treatment_name": "Ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2497, "treatment_name": "Nirmatrelvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]