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NCT05518487 · ClinicalTrials.gov registry record · Phase 2
COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study
A Phase 2 study of COVID-19 and Kidney Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 6
- Study locations
NCT05518487: Completed Phase 2 study of COVID-19 and Kidney Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05518487 is a Phase 2 study of COVID-19 and Kidney Transplant that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05518487, a Phase 2 study of COVID-19 and Kidney Transplant, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 6
- Study locations
Study Summary
An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have ≤2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer \>2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine
Primary Outcome
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Conditions Studied
Interventions
- BIOLOGICAL Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
Study Locations (6)
California
- University of California San Diego Medical Center: Transplantation - San Diego
- UCSF School of Medicine: Transplantation - San Francisco
Georgia
- Emory University School of Medicine: Transplantation - Atlanta
Illinois
- University of Illinois Medical Center: Transplantation - Chicago
Maryland
- Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit - Baltimore
Wisconsin
- University of Wisconsin School of Medicine and Public Health: Transplantation - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 2 |
What the finished NCT05518487 record still lists
NCT05518487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine is the first listed.
NCT05518487 lists 6 locations in 5 states (California, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT05518487 about?
NCT05518487 is a clinical study titled "COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study". An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have ≤2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrol...
What is the current status of trial NCT05518487?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-02-20. Estimated completion is 2024-11-06.
What conditions does trial NCT05518487 study?
This clinical trial studies the following conditions: COVID-19, Kidney Transplant.
What interventions are being tested in trial NCT05518487?
The interventions under investigation include: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05518487?
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 NCT05518487 being conducted?
This trial has 6 study locations across California, Georgia, Illinois, Maryland, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05518487's enrollment target sits among peer trials
15 290th of 298 higher than 8 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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