NCT05629923

EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS

EVALUATION OF COVID-19 VACCINATION EFFICACY AND CONTIXAGEVIMAB-CILGAVIMAB PROPHYLAXIS IN LIVER AND KIDNEY TRANSPLANT PATIENTS: PRELIMINARY STUDY

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are: * the evaluation of the antibody response after complete vaccination * the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB) All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Detailed description

Liver(LT) and kidney(KT) transplant patients are at high risk of mortality from COVID-19(16-29%, 28%; respectively). Although transplant patients undergo a full vaccination course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis (LAAB) has been proposed. However, the efficacy of these strategies has not yet been demonstrated in LT and KT. The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are: * the evaluation of the antibody response after complete vaccination * the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB) All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Conditions

• COVID-19 Pandemic
• Transplant-Related Disorder

Interventions

Type	Name	Description
DRUG	tixagevimab-cilgavimab(AZD7442, AstraZeneca)	In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-11-01
• Completion: 2022-11-30
• First posted: 2022-11-29
• Last updated: 2022-12-20

Locations

1 site across 1 country: Italy