Coronavirus InfectionNCT04373798
C-reactive Protein Levels Among Individuals With COVID-19
An observational study of Coronavirus Infection, run by Henning Bliddal at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- C-reactive protein
- How many people
- 1,006 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2020to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are COVID-19 positive at the check point test.
Who may be able to join
- A test for COVID-19 taken at the check point
- Signed, informed consent for blood test to be drawn for the Biobank
Who cannot join
- Former admission to hospital for COVID-19
- Direct admission from check point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronavirus Infection
- Being tested
- C-reactive protein
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-reactive proteinDiagnostic test
Measurement of CRP value from blood sample taken at covid19 check point (baseline).
| Study group | Role | What they receive |
|---|---|---|
| Suspected COVID-19 | Individuals with symptoms who are seen at covid19 check points for covid19 diagnosis. Receives: Diagnostic Test: C-reactive protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation
Admission to a hospital. Reason for admission is recorded.
Measured: within 28 days
Secondary outcomes (3)
Death
Measured: within 28 days
Transfer to Intensive Care Unit
Measured: within 28 days
Oxygen treatment during hospitalisation
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start4 May 2020
- Primary completion30 Aug 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bliddal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, DMSc, Principal investigator, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373798
- Sponsor's protocol ID
- APPI2-CV-2020-02
- Status last verified
- Aug 2021
- First submitted
- 1 May 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage Strategies Based on C-reactive Protein Levels Among Individuals With COVID-19: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04373798
- Acronym / sponsor ID
- APPI2-CV-2020-02
- Conditions
- Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Henning BliddalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected COVID-19 | – | Diagnostic Test: C-reactive proteinIndividuals with symptoms who are seen at covid19 check points for covid19 diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are COVID-19 positive at the check point test.
Key inclusion criteria (2 listed)
- A test for COVID-19 taken at the check point
- Signed, informed consent for blood test to be drawn for the Biobank
Key exclusion criteria (2 listed)
- Former admission to hospital for COVID-19
- Direct admission from check point.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-reactive proteinMeasurement of CRP value from blood sample taken at covid19 check point (baseline). | Diagnostic test | Suspected COVID-19 |
Primary outcome
Hospitalisation
Time frame: within 28 days
Admission to a hospital. Reason for admission is recorded.
3 secondary outcomes
Death
Time frame: within 28 days
Transfer to Intensive Care Unit
Time frame: within 28 days
Oxygen treatment during hospitalisation
Time frame: within 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bliddal, DMSc principal investigator
The Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Henning Bliddal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalisation (time frame: within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.