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Recruiting
NCT05624840
Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir
Conditions: COVID-19, Chronic Kidney Disease stage4, Chronc Kidney Disease Stage 5
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Chinese University of Hong Kong
Location: Hong Kong
Summary
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.
Eligibility Criteria
Inclusion Criteria:Aged 18 and above.COVID-19 infection and symptom onset no more than 5 days, with or without prior vaccination.WHO CPS 1-4Indicated for nirmatrelvir-ritonavir treatmentExclusion Criteria:Patients cannot swallow capsules or adhere to protocol.Severe COVID-19 disease, including patients who require oxygen supplement therapySignificant hypersensitivity to nirmatrelvir, ritonavir, or any component of the formulationPatients require co-administration of drugs that are highly dependent on CYP3A4 for clearance and cannot be omitted during the treatment period
Source: ClinicalTrials.gov (NCT05624840). StuddyBuddy aggregates publicly available trial information.