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Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir

COVID-19 Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The objectives of the study are to evaluate the safety and clinical and virologic outcomes of dose-adjusted nirmatrelvir-ritonavir in patients with eGFR lower than 30 ml/min/1.73 m^2. Patients with eGFR greater than 30 ml/min/1.73 m2 and prescribed nirmatrelvir-ritonavir will be used for comparison. In the single-centre study, patients with stage 4 and 5 chronic kidney disease prescribed early treatment dose-adjusted nirmatrelvir-ritonavir will be assessed for the primary endponts of adverse events during or after treatment with nirmatrelvir-ritonavir (starting on or before day 30), serious adverse events and adverse events leading to discontinuation of nirmatrelvir-ritonavir. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05624840
Study type Observational
Source Chinese University of Hong Kong
Contact
Status Completed
Phase
Start date November 7, 2022
Completion date February 1, 2023
View Details
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