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NCT04666025 · ClinicalTrials.gov registry record
SARS-CoV-2 Donor-Recipient Immunity Transfer
A clinical trial, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- 26
- Enrollment target
NCT04666025: Completed study, sponsored by City of Hope Medical Center.
NCT04666025 is a clinical trial that has completed, run by City of Hope Medical Center. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04666025 has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study Summary
This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.
Primary Outcome
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transf
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
- OTHER Diagnostic Laboratory Biomarker Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2023-05-05 |
What the finished NCT04666025 record still lists
NCT04666025 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04666025 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04666025 about?
NCT04666025 is a clinical study titled "SARS-CoV-2 Donor-Recipient Immunity Transfer". This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 inf...
What is the current status of trial NCT04666025?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2020-09-23. Estimated completion is 2023-05-05.
What interventions are being tested in trial NCT04666025?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER), Diagnostic Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT04666025?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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