The Safety of Paxlovid in Hemodialysis Patients With Covid-19
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 (Nirmatrelvir/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 nirmatrelvir 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 nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days. The primary outcome is the number of patients whose ALT, AST or total bilirubin increase two times from baseline. The secondary outcome is the number of patients whose SARS-CoV-2 lower than 500 copies/mL.
Timeline
- Start
- 2022-05-06
- Primary completion
- 2022-06-06
- Completion
- 2022-06-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirmatrelvir | Small molecule | 150 mg | — |
| Subject | Nirmatrelvir | Small molecule | 300 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
Indications
No indication recorded.