Overview

The Safety of Paxlovid in Hemodialysis Patients With Covid-19

Status:
Not yet recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Infection with SARS-CoV-2 continue to threaten global health. Persons with chronic kidney disease, including dialysis treatment are at hight risk for severe Covid-19 and associated adverse outcomes. Paxlovid (Nirmatrelwei/Ritonavir) decreases risk of progression to severe Covid-19. It is not recommended for dialysis patients because due to lack of data. The aim of the present study is evaluate the safety of Paxlovid in hemodialysis patients with SARS-CoV-2 infection. This is a prospective study. In stage 1 arm, 10 hemodialysis patients with SARS-COV-2 infection will be treated with nirmatrelwei 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days. In stage 2 arm, 10 patients will be treated with nirmatrelwei 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days. The primary outcome is the change of liver function. The secondary outcome is the change of CT value of SARS-CoV-2 nucleic acid.
Phase:
Phase 4
Details
Lead Sponsor:
RenJi Hospital
Treatments:
Ritonavir