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NCT05629923

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

Completed Last updated 20 December 2022
What this trial tests

trial testing tixagevimab-cilgavimab(AZD7442, AstraZeneca) in COVID-19 Pandemic in 306 participants. Completed in 30 November 2022.

Timeline
1 February 2022
Primary endpoint
1 November 2022
30 November 2022

Quick facts

Lead sponsorUniversity of Rome Tor Vergata
StatusCompleted
Study typeOBSERVATIONAL
Enrollment306
Start date1 February 2022
Primary completion1 November 2022
Estimated completion30 November 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Rome Tor Vergata

Who can join

Adults 18 to 99, any sex, with COVID-19 Pandemic or Transplant-Related Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients.
    Angelico R, Romano F, Coppola L, Materazzo M, et al · · 2023 · cited 4× · PMID 38138204 · DOI 10.3390/medicina59122101

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Other recruiting trials for COVID-19 Pandemic

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05629923.

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