Effectiveness and Safety of Tixagevimab-Cilgavimab for COVID-19 Prevention in Chronic Dialysis Patients

Tixagevimab-cilgavimab for preventing breakthrough COVID-19 in dialysis patients: A prospective study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20221031004

Enrollment

200

Registered

2022-10-31

Start date

2022-11-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effectiveness of long acting antibody in ESKD patients requiring dialysis dialysis, long acting antibody, COVID-19, safety, hemodialysis, peritoneal dialysis

Interventions

tixagevimab-cilgavimab 1.5 ml IM at each gluteus muscles (2 doses

one for each buttock),Participants who do not receive tixagevimab-cilgavimab

Active Comparator Drug,No Intervention No treatment

tixagevimab-cilgavimab ,Comparator

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Effectiveness of tixagevimab-cilgavimab 6 months Incidence of COVID-19	—

Secondary

Measure	Time frame
Safety of tixagevimab-cilgavimab Day 1, 3 , 7 Proportions of patients who experience side effects	—

Countries

Thailand

Contacts

Public ContactSarinya Boongird

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

sarinya.bon@mahidol.ac.th022011400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026