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SPHPS: The Safety of Paxlovid in Hemodialysis Patients With Covid-19

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05366192
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nirmatrelvir and ritonavir stage 1
  • Drug: Nirmatrelvir and ritonavir stage 2
 Phase 4

Detailed Description

This is a prospective, two arms (two stage) study. There will be include 20 subjects. The including criteria are 1.Understand the present study/Agree and sign informed consent; 2. Age is between 18 and 75 men or women 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 SARS-CoV-2 and the CT value of nucleic acid detection<35. The exclusion criteria are 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.Patients who are treated with medicines 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.

Subjects in stage 1 arm 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 subjects will be treated with nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days. All of subjects will received hemodialysis two times during the study.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Safety of Paxlovid (Nirmatrelvir/Ritonavir) in Hemodialysis Patients With SARS-CoV-2 Infection
Actual Study Start Date :
May 6, 2022
Actual Primary Completion Date :
Jun 6, 2022
Actual Study Completion Date :
Jun 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paxlovid stage 1 group

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
Nirmatrelvir 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days.
Other Names:
  • small dose

    		•
    Experimental: Paxlovid stage 2 group

    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
    Nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days.
    Other Names:
  • high dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of Liver function [5 days]

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

    Secondary Outcome Measures

    1. The effectiveness of Paxlovid [5 days]

      Number of patients whose SARS-CoV-2 lower than 500copies/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

      1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nephrology, Renji Hospital, Shanghai JiaoTong University School of Medicine Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Principal Investigator: Leyi Gu, Renal Division, Renji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05366192
    Other Study ID Numbers:
    • IIT-2022-0067
    First Posted:
    May 9, 2022
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Ritonavir

    Study Results

    No Results Posted as of Jun 14, 2022