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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341103
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
CareDx

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

Condition or disease
Solid Organ Transplant Rejection COVID-19

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.

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



Primary Outcome Measures :
  1. Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19 [ Time Frame: 6 months ]
    AlloSure dd-cfDNA blood draw values



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Solid organ (liver, heart, lung or kidney) transplant recipients diagnosed with suspected or confirmed case of COVID-19
Criteria

Inclusion Criteria:

  • Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341103


Contacts
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Contact: Alana Burns 415.287.2420 aburns@caredx.com

Sponsors and Collaborators
CareDx
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Responsible Party: CareDx
ClinicalTrials.gov Identifier: NCT04341103    
Other Study ID Numbers: Al-COVE
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No