NCT04373798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,006

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

May 1, 2020

Last Update Submit

August 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospitalisation

    Admission to a hospital. Reason for admission is recorded.

    within 28 days

Secondary Outcomes (3)

  • Death

    within 28 days

  • Transfer to Intensive Care Unit

    within 28 days

  • Oxygen treatment during hospitalisation

    within 28 days

Study Arms (1)

Suspected COVID-19

Individuals with symptoms who are seen at covid19 check points for covid19 diagnosis.

Diagnostic Test: C-reactive protein

Interventions

C-reactive proteinDIAGNOSTIC_TEST

Measurement of CRP value from blood sample taken at covid19 check point (baseline).

Suspected COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Henning Bliddal, DMSc

    The Parker Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 4, 2020

Study Start

May 4, 2020

Primary Completion

August 30, 2020

Study Completion

March 30, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations