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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05624840). StuddyBuddy aggregates publicly available trial information.