C-reactive Protein Levels Among Individuals With COVID-19

Triage Strategies Based on C-reactive Protein Levels Among Individuals With COVID-19: A Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: Diagnostic test: C-reactive protein

• Study Type: Observational
• Enrollment (Actual): 1006

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected COVID-19; Individuals with symptoms who are seen at covid19 check points for covid19 diagnosis.	Diagnostic test: C-reactive protein; Measurement of CRP value from blood sample taken at covid19 check point (baseline).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henning Bliddal

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: APPI2-CV-2020-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No