How Routine Biomarkers and Blood Leucocytes Count Can Assist Diagnosis of COVID-19 in Emergency Department

NCT04401241 | Completed

• 1 other identifier: 20-06
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

December 2019 was the onset of an outbreak of an infection related to SARS-CoV-2, a new coronavirus detected in January 2020 and responsible for a disorder termed COVID-19. Since then, COVID-19 has spread worldwide and is responsible for an unprecedented pandemic with major threat on global health and social and economic stability. Covid-19 has a large spectrum of symptoms. Most patients experience mild or moderate flu-like disorder with cough, fever, and shortness of breath. More severe presentations may occur; patients sometimes develop an acute pneumonia that can lead to adult respiratory distress syndrome. A considerable number of publications have been released for the last 10 weeks to help physicians making diagnosis and treat patients. Chinese authors have extensively proposed description of the disease. As signs and symptoms are poorly specific, diagnosis mostly relies on detection of the virus by RT-PCR in the upper respiratory tract. Some uncommon images and localization are highly specific and sensitive on chest CT-scan, which is cornerstone for initial diagnosis. However, resources may lack during healthcare crisis and results of these investigations may be delayed or unavailable developper. Special attention should also be paid to usual laboratory analysis. Indeed, decreased lymphocytes and eosinophilic counts are frequently described as well as increase in D-dimers levels. Variation of C-reactive protein (CRP) and procalcitonin (PCT) have been reported. Coronavirus may have cardiac tropism and changes in cardiac biomarkers concentration may occur. Therefore, some data suggest that values of routine biomarkers and blood cell count may assist physicians at bedside to support diagnosis of COVID-19. To face the outbreak, organization of emergency departments (ED) was mandatory to separate patients flows and avoid mixing patients with COVID-19 and others. Most patients visiting EDs dedicated to initial COVID-19 management suffered of pneumonia-like symptoms. Despite initial triage, patients had either COVID-19-related pneumonia either alternative diagnoses. We took advantage of this to evaluate the ability of routine biomarkers and leucocytes count helping identification of COVID-19 from alternative diagnoses.

Conditions

Covid19

Keywords

Covid19, biomarkers

Outcome Measures

Primary Outcomes (1)

• routine biomarkers and blood cell count are discriminant to diagnose COVID-19

  assess sensitivity of routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia in low and high probability groups for level of certainty using the adjudication committee classification

  2 months

Secondary Outcomes (8)

• Probability of COVID-19 and CRP

  2 months

• Probability of COVID-19 and PCT

  2 months

• Probability of COVID-19 and Ddimers

  2 months

• Probability of COVID-19 and NTproBNP

  2 months

• Probability of COVID-19 and cTnT-HS

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the study purpose and to ensure quality of the final adjudication committee diagnosis, we selected consecutive adults visiting the COVID19 dedicated ED if they presented with clinically suspected COVID19-related pneumonia and had SARS-Cov-2 RT-PCR and/or low dose chest CT-scan. Clinically suspected COVID-19-related pneumonia was based on physician's own judgment and if they fulfilled the following criteria: new onset of features concordant with viral infection (at least one among: sweat, chills, aches and pain, temperature ≥38°C or \<36°C or perception of fever, loss of smell and/or taste) and symptoms of an acute lower respiratory tract illness (at least one among: cough, sputum production, respiratory rate ≥20 per minute, dyspnea, chest pain, altered breathing sounds at auscultation)

You may qualify if:

• patient suspected of COVID19

You may not qualify if:

• patient unsuspected of COVID19

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, MON, 98000, Monaco

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 26, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 15, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

MO (1)