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NCT05077254 · ClinicalTrials.gov registry record · Phase 2

COVID Protection After Transplant-Immunosuppression Reduction

A Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
48
Enrollment target
15
Study locations

NCT05077254: Completed Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT05077254 is a Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 66-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (27% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05077254, a Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target
15
Study locations

Study Summary

This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.

Primary Outcome

Serum antibody titer will be measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay. Values \> 1 represent increase from baseline; values \< 1 represent decrease from baseline.

Conditions Studied

Kidney Transplant Recipients Liver Transplant Recipients

Interventions

  • BIOLOGICAL Pfizer-BioNTech COVID-19 Vaccine 2023-2024
  • BIOLOGICAL Moderna COVID-19 Vaccine 2023-2024
  • DRUG SOC IS Regimen
  • DRUG SOC IS Reduction

Study Locations (15)

New York

  • NYU Langone Transplant Institute - New York
  • Mt. Sinai Hospital - New York
  • Weill Cornell Medicine - New York

California

  • University of California, San Diego - San Diego
  • University of California San Francisco Health - San Francisco

Illinois

  • University of Illinois Health - Chicago
  • Northwestern University - Evanston

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • University of Pittsburgh - Pittsburgh

Georgia

  • Emory Healthcare - Atlanta

Iowa

  • University of Iowa Hospitals - Iowa City

Louisiana

  • Ochsner Health - New Orleans

Maryland

  • Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2021-12-06
Est. Completion 2025-02-21
Phase Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT05077254 record still lists

NCT05077254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 66-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (27% lower).

The record links to 2 conditions, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 4 interventions - of which Pfizer-BioNTech COVID-19 Vaccine 2023-2024 is the first listed.

NCT05077254 lists 15 locations in 10 states (New York, California, Illinois).

Frequently Asked Questions

What is clinical trial NCT05077254 about?

NCT05077254 is a clinical study titled "COVID Protection After Transplant-Immunosuppression Reduction". This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppressi...

What is the current status of trial NCT05077254?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-12-06. Estimated completion is 2025-02-21.

What conditions does trial NCT05077254 study?

This clinical trial studies the following conditions: Kidney Transplant Recipients, Liver Transplant Recipients.

What interventions are being tested in trial NCT05077254?

The interventions under investigation include: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 (BIOLOGICAL), Moderna COVID-19 Vaccine 2023-2024 (BIOLOGICAL), SOC IS Regimen (DRUG), SOC IS Reduction (DRUG).

Who is sponsoring clinical trial NCT05077254?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05077254 being conducted?

This trial has 15 study locations across California, Georgia, Illinois, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT05077254, the US trial registry maintained by the National Library of Medicine. NCT05077254 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.