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

• Conditions: Solid Organ Transplant Rejection; COVID-19

• Registration Number: NCT04341103
• Lead Sponsor: CareDx

Brief Summary

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

Study Timeline

• Study First Submitted: 2020-03-16
• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-10
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-12-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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