The Safety of Paxlovid in Hemodialysis Patients With Covid-19
Condition: Safety Issues
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Nirmatrelvir and ritonavir stage 1; Nirmatrelvir and ritonavir stage 2
Intervention type(s): Drug; Drug
Intervention description(s): Nirmatrelvir 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days.; Nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days.
Other intervention name(s): small dose; high dose
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment