The Safety of Paxlovid in Hemodialysis Patients With Covid-19

NCT05366192 | Completed Phase 4 DMC

• 1 other identifier: IIT-2022-0067
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• Change of Liver function

  Number of patients whose ALT, AST or total bilirubin increase 2 times from baseline

  5 days

Secondary Outcomes (1)

• The effectiveness of Paxlovid

  5 days

Study Arms (2)

Paxlovid stage 1 group

EXPERIMENTAL

Subjects in stage 1 will be treated with nirmatrelvir 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days.

Drug: Nirmatrelvir and ritonavir stage 1

Paxlovid stage 2 group

EXPERIMENTAL

In stage 2, subjects will be treated with nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days.

Drug: Nirmatrelvir and ritonavir stage 2

Interventions

Nirmatrelvir and ritonavir stage 1 DRUG

Nirmatrelvir 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days.

Also known as: small dose

Paxlovid stage 1 group

Nirmatrelvir and ritonavir stage 2 DRUG

Nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days.

Also known as: high dose

Paxlovid stage 2 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the present study/Agree and sign informed consent.
• Age is between 18 and 75 at the screening
• Blood purification twice or three times/week, including hemodialysis, hemofiltration, hemodiafiltration, CRRT or hybrid blood purification.
• Regular hemodialysis≥1 month
• Patients with arteriovenous fistula or artificial arteriovenous fistula.
• Patients infected with Covid-19, the PCR CT value of nucleic acid detection\<35.

You may not qualify if:

• Blood purification treatment\<1month.
• Liver function (ALT or AST) is three times the upper the normal.
• The severe or critical patients with Covid-19.
• 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.
• Patients with galactose intolerance.
• \. Pregnant and lactating women.
• Patients was allergic to paxlovid.
• Participating in other intervention studies.
• The investigator judged that the condition of the subjects was not suitable for the study.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Nephrology, Renji Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

nirmatrelvir

Study Officials

• Leyi Gu

  Renal Division, Renji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: May 6, 2022
• Primary Completion: June 6, 2022
• Study Completion: June 8, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: September, 2022
• Access Criteria: Publication

Locations

CN (1)