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AzTrials

Covid19DELOCOVIDNCT04786249

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

An observational study of Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
How many people
2,488 participants
Where
1 siteFrance
Study dates
24 Feb 2021to 6 May 2022
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: 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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint-Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

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

Read the detailed description

Early detection with a sensitive technique of COVID-19 is essential to ensure rapid and appropriate patient management, to contain the epidemic and to better understand the global epidemiology of the virus. This detection will intensify in the coming months due to the start of the school year and university as well as the economic recovery. Until now, laboratory diagnostics have relied primarily on the amplification and detection of viral gene sequences in upper respiratory tract samples performed in a centralized laboratory. A new test (Abbott ID NowTM COVID-19) is available on the market. This test is the first in France to be able to be carried out in a delocalized medical biology examination (DMBE) and makes it possible to return a result in less than 15 min directly in the clinical department. The speed of this technique is based on the use of isothermal gene amplification. The investigators will be the first to evaluate it in France in delocalized biology.

The improvement in diagnostic technique, concomitant with the development of knowledge on the pathophysiology and specific therapies, has been accompanied by better therapeutic management of patients with Covid19. To date, dexamethasone represents the first class of drugs proven to be effective in reducing mortality from COVID-19 in patients with severe disease. Anticoagulant treatment at a prophylactic dose in hospitalized patients or at risk for the severe form, and at a curative dose for severe forms is also the subject of strong recommendations due to the high incidence of venous and arterial thromboembolic events in these patients. It is also recommended that the use of broad-spectrum antibiotics be reserved for patients with radiological abnormalities compatible with bacterial superinfection and / or requiring oxygen therapy greater than or equal to 6 liters / min.

In France, systematic screening for SARS-CoV-2 infection in the emergency room before hospitalization, an operating room, or transfer to another establishment. At GhPSJ, the reference RT-PCR technique Simplexa ™ COVID-19 Direct assay has been used routinely since July 2020 by the microbiology laboratory. It allows a result rendering in a minimum delay of 50 minutes. Since September 7, 2020, the prescription of an RT-PCR is systematically associated with a dedicated computerized questionnaire on the DxCare® software completed by the emergency physician. It collects the reason for prescribing RT-PCR: "diagnostic suspicion", "bed management", "preoperative screening", or "screening for transfer to another establishment"; the patient's lifestyle; the symptomatic or asymptomatic nature and the duration of the symptoms. Since October 22, 2020, the DMBE with the Test ID NowTM COVID-19 has been installed and implemented in the Emergency Department. It is used by the trained and authorized Emergency Nursing team for any patient having a prescription for RT-PCR Sars-CoV-2 by the emergency physician.

The investigators wish to verify the hypothesis that obtaining the rapid diagnosis of Sars-CoV-2 infection by DMBE in the emergency room (Test ID NowTM COVID-19) makes it possible to optimize the organizational and medical management of emergency room patients having a Sars-CoV-2 RT-PCR test. In the literature, there is no study available evaluating the impact of a rapid examination in delocalized biology on the medical management of patients in an emergency department.

Conditions
Covid19
Keywords
Rapid test
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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®)

    Measured: Day 1

Secondary outcomes (7)
  1. Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the final orientation of the patient

    Number of returns home and the number of hospitalizations in conventional services and intensive care.

    Measured: Day 1

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

    Number of admissions in single and double rooms

    Measured: Day 1

  3. 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

    Number of blood tests, ECG, chest X-ray, chest CT scan without injection, pulmonary CT angiography

    Measured: Day 1

  4. 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

    Introduction of corticosteroid therapy and anticoagulation

    Measured: Day 1

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

    Number of antibiotic treatments

    Measured: Day 1

  6. Compare the primary endpoint for two subgroups of patients according to their treatment schedule

    Number of patients who had a PCR prescription by the day medical team between 8:31 a.m. and 6:30 p.m. and those who had a PCR prescription by the on-call medical team between 6:31 p.m. and 8:30 a.m.

    Measured: Day 1

  7. Evaluate the level of satisfaction and the feelings of the medical and paramedical teams of the Emergency Department regarding the DMBE Test ID Now ™ COVID-19 and its impact

    Staff questionnaire (satisfied or not satisfied)

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start24 Feb 2021
  3. Primary completion26 Feb 2021
  4. Study completion6 May 2022

Resources

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
Retrospective
Enrolment
2,488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786249
Sponsor's protocol ID
DELOCOVID
Acronym
DELOCOVID
Status last verified
May 2022
First submitted
5 Mar 2021
Last updated
11 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34879491

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 3 inclusion and 4 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 11 May 2022. 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 France. 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?

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 frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786249, which also lists 1 linked publication.

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 11 May 2022.

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