AlloSure Guided Immuno-Optimization for COVID-19: An Earl... | NCT04341103

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

NCT04341103

Sponsor

CareDx

Status

Unknown status

Last Update Posted

Apr 10, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Solid Organ Transplant Rejection
COVID-19

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Estimated

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Mar 16, 2020

First Submission Date that Met QC Criteria

Apr 8, 2020

First Posted Date

Apr 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2020

Last Update Posted Date

Apr 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19	AlloSure dd-cfDNA blood draw values	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Solid organ (liver, heart, lung or kidney) transplant recipients diagnosed with suspected or confirmed case of COVID-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alana Burns	Contact	415.287.2420		aburns@caredx.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided