Status:
COMPLETED
The Safety of Paxlovid in Hemodialysis Patients With Covid-19
Lead Sponsor:
RenJi Hospital
Conditions:
Safety Issues
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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. P...
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 an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 6\. 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.
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05366192
Start Date
May 6 2022
End Date
June 8 2022
Last Update
June 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Nephrology, Renji Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127