COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05567952

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

2022-10-05

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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.

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

2

Pfizer

12

100

Canada;Germany;Greece;Italy;Taiwan;United States

Mild disease at enrollment

1: Mild disease at enrollment

411

The change in viral SARS-CoV-2 RNA level as measured in nasopharyngeal (NP) swabs

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]