C-reactive Protein Levels Among Individuals With COVID-19 | NCT04373798

Studies
C-reactive Protein Levels Among Individuals With COVID-19

NCT04373798

Sponsor

Henning Bliddal

Status

Completed

Last Update Posted

Aug 18, 2021Actual

Enrollment

1,006Actual

Phase

Not provided

Conditions

Coronavirus Infection

Interventions

C-reactive protein

Countries

Denmark

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2020Actual

Primary Completion Date

Aug 30, 2020Actual

Completion Date

Mar 30, 2021Actual

First Submitted Date

May 1, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 4, 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

Aug 17, 2021

Last Update Posted Date

Aug 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 primary objective of this multi-center study is to clarify the value of a CRP measurement for triage of patients initially presenting with light symptoms of the COVID-19 infection.

Current recommendations of management of COVID-19 include large-scale tests for virus. Such tests reveal whether an individual is infected with the virus, however, the demonstration of virus per se has no prognostic value for the ensuing course of the COVID-19 disease. Publications of possible treatments strategies increase exponentially, while evidence of triage of the affected individuals is mainly based on the level of pulmonary affection as measured by the Oxygen saturation.

To inform decision making for which patients are to be hospitalized due to risk of developing more severe affection, this study addresses the question, whether triage may be performed with the aid of a simple CRP measurement.

Detailed Description

Not provided

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

Retention

Enrollment

1,006Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected COVID-19		Individuals with symptoms who are seen at covid19 check points for covid19 diagnosis.	Diagnostic Test: C-reactive protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-reactive protein	Diagnostic Test	Measurement of CRP value from blood sample taken at covid19 check point (baseline).	Suspected COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalisation	Admission to a hospital. Reason for admission is recorded.	within 28 days

Secondary Outcomes

Measure	Description	Time Frame
Death		within 28 days
Transfer to Intensive Care Unit		within 28 days
Oxygen treatment during hospitalisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A test for COVID-19 taken at the check point
Signed, informed consent for blood test to be drawn for the Biobank

Exclusion Criteria:

Former admission to hospital for COVID-19
Direct admission from check point.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals who are COVID-19 positive at the check point test.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henning Bliddal, DMSc	The Parker Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Parker Institute, Frederiksberg Hospital		Copenhagen		2000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided