Impact of Rapid Screening for COVID-19 in Delocalized Biology in the Emergency Department

NCT04786249 | Completed

• 1 other identifier: DELOCOVID
• Study Type: observational
• Target: 2,488
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, first appeared in China, and then spread around the world. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the entire virus genome was sequenced. This new coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) for its genetic homology with SARS-CoV-2, has shown worldwide expansion. Thus, on January 30, 2020, the World Health Organization (WHO) announced the COVID-19 epidemic as a threat to public health at the international level, then, in March 2020, the global situation degenerated into a pandemic. . Johns Hopkins University has reported more than 7,600,000 cases of infections and more than 427,000 deaths as of June 13, 2020. Due to the rapid progression of the COVID-19 pandemic and the limited capacity of molecular laboratory tests, the concept of delocalized molecular tests appears to be relevant. Indeed, the urgent need to increase testing for COVID-19 has been clearly identified as an essential part of the strategy to combat the coronavirus worldwide. In fact, COVID-19 represents a major public health problem currently causing a rapidly increasing number of infections and significant morbidity and mortality worldwide. As of July 1, 2020, more than 10 million people worldwide have been infected with SARS-CoV-2. As of December 20, 2020, this tally is 76,624,363 cases of contamination and 1,690,658 deaths following Johns Hopkins University

Conditions

Covid19

Keywords

Rapid test

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of a short delay in delivering results in delocalized biology on the emergency medical care time, in comparison with the reference method by RT-PCR at the central laboratory of microbiology

  Time of medical care in the emergency department corresponding to the time between the first medical contact (time stamp of the medical observation traced in DxCare®) and the patient's discharge from the Emergency Department (time stamp of the stay in DxCare®)

  Day 1

Secondary Outcomes (7)

• Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the final orientation of the patient

  Day 1

• Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the bed management

  Day 1

• Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the number of additional examinations carried out and their deadline

  Day 1

• Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the prescriptions and the timeframe for the implementation of specific therapies against Covid-19 in hospitalized patients

  Day 1

• Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the prescription of antibiotic treatments

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency unit of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient during the two periods of 7 weeks: * Period 1 (weeks 37 to 43 of the year 2020): RT PCR SARS-CoV-2 was carried out in the microbiology laboratory * Period 2 (44 to 50 of the year 2020): diagnosis of SARS-CoV-2 infection with the ID Now ™ technique in emergencies in DMBE with respect for the standards and recommendations of delocalized biology. The number of patients included will be 1200 per period.

You may qualify if:

• Patient aged ≥ 18 years
• Patient presenting to the emergency unit of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient
• French-speaking patient

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of their data for this research.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• Gerlier C, Pilmis B, Ganansia O, Le Monnier A, Nguyen Van JC. Clinical and operational impact of rapid point-of-care SARS-CoV-2 detection in an emergency department. Am J Emerg Med. 2021 Dec;50:713-718. doi: 10.1016/j.ajem.2021.09.062. Epub 2021 Sep 28.

  PMID: 34879491 RESULT

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 Officials

• Jean-Claude NGUYEN

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 8, 2021
• Study Start: February 24, 2021
• Primary Completion: February 26, 2021
• Study Completion: May 6, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

FR (1)