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Completed

NCT Number: NCT05629923

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli Studi di Roma Tor Vergata

Roma, 00133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • KT and LT transplant patients in follow up in Tor Vergata University
  • Age >18 years
  • At least 3 month post transplantation

Exclusion criteria

  • pediatric recipients
  • Active covid infection at the time of the study
  • Pregnancy
  • Allergy to any ingredients included in the vaccine
  • Acute liver or kidney acute rejection proven by biopsy
  • Acute Febrile state with either leucopenia or leucocytosis
  • High dose of corticosteroid at study timing (pulse methyl prednisolone)

Treatment and study plan

tixagevimab-cilgavimab(AZD7442, AstraZeneca)

Drug

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

Primary outcomes

  1. COVID-19 vaccination response rate

    Time frame: time 0

    The objective of our study is the evaluation of the antibody response after complete vaccination. The anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche).

  2. Clinical efficacy of LAAB prophylaxis

    Time frame: three months from LAAB prophilaxys

    After COVID-19 title evaluation, 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.

Secondary outcomes

  1. Serological title at six months

    Time frame: Six months from LAAB prophylaxis

    At six months, all the patients who underwent to to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca), the anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche).

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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