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

NCT05629923 | Completed

• 1 other identifier: COVID-19 TRANPLANT
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pandemic; Transplant-Related Disorder

Keywords

transplant; Vaccination; COVID-19 pandemic

Outcome Measures

Primary Outcomes (2)

• COVID-19 vaccination response rate

  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).

  time 0

• Clinical efficacy of LAAB prophylaxis

  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.

  three months from LAAB prophilaxys

Secondary Outcomes (1)

• Serological title at six months

  Six months from LAAB prophylaxis

Study Arms (1)

Kidney and Liver Transplant

All Kidney and Liver Transplant recipients who are at follow-up in our institution will be enrolled. anti-COVID-19 title was obtained by 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.

Drug: tixagevimab-cilgavimab(AZD7442, AstraZeneca)

Interventions

tixagevimab-cilgavimab(AZD7442, AstraZeneca) DRUG

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

Kidney and Liver Transplant

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent KT and LT transplant currently in follow up in Tor Vergata University hospital

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Università degli Studi di Roma Tor Vergata

Roma, 00133, Italy

Location

Related Publications (3)

• Hardgrave H, Wells A, Nigh J, Klutts G, Krinock D, Osborn T, Bhusal S, Rude MK, Burdine L, Giorgakis E. COVID-19 Mortality in Vaccinated vs. Unvaccinated Liver & Kidney Transplant Recipients: A Single-Center United States Propensity Score Matching Study on Historical Data. Vaccines (Basel). 2022 Nov 13;10(11):1921. doi: 10.3390/vaccines10111921.

  PMID: 36423017 BACKGROUND

• Angelico R, Blasi F, Manzia TM, Toti L, Tisone G, Cacciola R. The Management of Immunosuppression in Kidney Transplant Recipients with COVID-19 Disease: An Update and Systematic Review of the Literature. Medicina (Kaunas). 2021 Apr 30;57(5):435. doi: 10.3390/medicina57050435.

  PMID: 33946462 BACKGROUND

• Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.

  PMID: 35443106 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in General Sugery PhD FEBS

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: November 29, 2022
• Study Start: February 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)