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Al-COVE: AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience

Sponsor
CareDx (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04341103
Collaborator
(none)
500
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    An observational case series of patients with solid organ transplants who have been admitted with suspected COVID-19 utilizing AlloSure dd-cf DNA to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience
    Anticipated Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Mar 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19 [6 months]

      AlloSure dd-cfDNA blood draw values

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CareDx

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CareDx
    ClinicalTrials.gov Identifier:
    NCT04341103
    Other Study ID Numbers:
    • Al-COVE
    First Posted:
    Apr 10, 2020
    Last Update Posted:
    Apr 10, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 10, 2020