C-reactive Protein Levels Among Individuals With COVID-19

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373798
• Other study ID #: APPI2-CV-2020-02
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2021
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: March 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Diagnostic Test:
• C-reactive protein
Measurement of CRP value from blood sample taken at covid19 check point (baseline).

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Henning Bliddal

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalisation	Admission to a hospital. Reason for admission is recorded.	within 28 days
Secondary	Death		within 28 days
Secondary	Transfer to Intensive Care Unit		within 28 days
Secondary	Oxygen treatment during hospitalisation		within 28 days