Effectiveness and Safety of Tixagevimab-Cilgavimab for COVID-19 Prevention in Chronic Dialysis Patients
- Conditions
- Effectiveness of long acting antibody in ESKD patients requiring dialysisdialysis, long acting antibody, COVID-19, safety, hemodialysis, peritoneal dialysis
- Registration Number
- TCTR20221031004
- Lead Sponsor
- Faculty of Medicine Ramathibodi Hospital, 366 Mahidol University (Funding No.: RF_66023)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. End stage kidney disease patients requiring chronic dialysis aged equal or above 18 years
2. Body weight equal or above 40 kg
3. On kidney replacement therapy for at least 1 month
4. Achieve dialysis adequacy (Kt/V urea equal or greater than 1.2 or 1.8 for hemodialysis patients on three or two dialysis sessions per week, respectively; or weekly Kt/V urea equal or greater than 1.7 for peritoneal dialysis patients)
5.Agree to participate in this study
6.Meet at least one of the following criteria
6.1 had received at least 3 doses of COVID-19 vaccine (any regimen) with the most recent dose administered at least 2 weeks before enrollment
6.2 unable to tolerate COVID-19 vaccine side effects or had contraindication for COVID-19 vaccine
6.3 not meeting the above criteria but providing long acting antibody may be appropriate according to physician's opinion
1. Current active COVID-19 or previously diagnosed with COVID-19 within 3 months before enrollment
2.Pregnant or breastfeeding woman
3.Uncontrolled arrhythmia or diagnosed with acute coronary syndrome within 6 months before enrollment
4.Life expectancy less than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of tixagevimab-cilgavimab 6 months Incidence of COVID-19
- Secondary Outcome Measures
Name Time Method Safety of tixagevimab-cilgavimab Day 1, 3 , 7 Proportions of patients who experience side effects