Safety and Clinical and Virologic Outcomes in COVID-19 Patients With Chronic Kidney Disease Treated With Nirmatrelvir-ritonavir

CRE-2022.361

Nirmatrelvir-ritonavir is approved for coronavirus disease 2019 (COVID-19) but not initially recommended in patients with severe renal impairment. Increasing observational data have shown the feasibility of dose-adjusted nirmatrelvir-ritonavir administration in patients with estimated glomerular filtration rate lower than 30 ml/min/1.73 m\^2. The study is planned to assess the safety, clinical and virologic outcomes of early oral nirmatrevir-ritonavir treatment of COVID-19 in patients with stage 4 and 5 chronic kidney disease.

2022-11-07

2023-01-31

2023-02-01

Completed

85

Inclusion Criteria: * Aged 18 and above. * COVID-19 infection and symptom onset no more than 5 days, with or without prior vaccination. * WHO CPS 1-4 * Indicated for nirmatrelvir-ritonavir treatment Exclusion Criteria: * Patients cannot swallow capsules or adhere to protocol. * Severe COVID-19 disease, including patients who require oxygen supplement therapy * Significant hypersensitivity to nirmatrelvir, ritonavir, or any component of the formulation * Patients require co-administration of drugs that are highly dependent on CYP3A4 for clearance and cannot be omitted during the treatment period

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 85, 'type': 'ACTUAL'}}

2024-02-07