Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04786249 |
| Other study ID # |
DELOCOVID |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2021 |
| Est. completion date |
May 6, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
