EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS
NCT ID: NCT05629923
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
306 participants
OBSERVATIONAL
2022-02-01
2022-11-30
Brief Summary
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* 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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
tixagevimab-cilgavimab(AZD7442, AstraZeneca)
In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).
Interventions
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tixagevimab-cilgavimab(AZD7442, AstraZeneca)
In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* At least 3 month post transplantation
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Roberta Angelico
Lecturer in General Sugery PhD FEBS
Locations
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Università degli Studi di Roma Tor Vergata
Roma, , Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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COVID-19 TRANPLANT
Identifier Type: -
Identifier Source: org_study_id