The Safety of Paxlovid in Hemodialysis Patients With Covid-19

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• 1.Understand the present study/Agree and sign informed consent.

• 2.Age is between 18 and 75 at the screening

• 3.Blood purification twice or three times/week, including hemodialysis, hemofiltration, hemodiafiltration, CRRT or hybrid blood purification.

• 4.Regular hemodialysis≥1 month

• 5.Patients with arteriovenous fistula or artificial arteriovenous fistula.

• 6.Patients infected with Covid-19, the PCR CT value of nucleic acid detection<35.

Exclusion Criteria:

• 1.Blood purification treatment<1month.

• 2.Liver function (ALT or AST) is three times the upper the normal.

• 3.The severe or critical patients with Covid-19.

• 4.Drug that highly dependent on CYP3A, including but not limit to afzosin, pethidine, ranolazine, amiodarone, propafenone, quinidine, fusidic acid, voriconazole, terfenadine, colchicine, rifabutin, clozapine, dihydroergot, cisapride, simvastatin, diazepam, salbutam, triazolam, carbamazepine, phenobarbital, rifampicin.

• 5.Patients with galactose intolerance.

• 6. Pregnant and lactating women.

• 7.Patients was allergic to paxlovid.

• 8.Participating in other intervention studies.

• 9.The investigator judged that the condition of the subjects was not suitable for the study.