Covid19 Clinical Trial
— COVID-IDNowOfficial title:
Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay in Off-site Biology in Emergency Rooms for COVID-19 Screenin
Verified date | May 2022 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (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 SARS-CoV-2 for its genetic homology with SARS-CoV, has shown worldwide spread. 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, 20203. 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-211. As of August 25, 2020, this tally is 23,741,562 cases of contamination and 813,820 deaths following Johns Hopkins University.
Status | Completed |
Enrollment | 1265 |
Est. completion date | May 9, 2022 |
Est. primary completion date | December 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient aged = 18 years - Patient presenting to the emergency room of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient - French-speaking patient - Patient affiliated with social security or, failing that, with another health insurance system - Patient capable of giving free, informed and express consent. Exclusion Criteria: - Pregnant or breastfeeding patient. - Patient under guardianship or curatorship - Patient deprived of liberty - Patient under legal protection. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint-Joseph | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
NguyenVan JC, Gerlier C, Pilmis B, Mizrahi A, Péan de Ponfilly G, Khaterchi A, Enouf V, Ganansia O, Le Monnier A. Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department. J Clin Virol. 2021 Dec;145:105021. doi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the diagnostic performance of the ID Now ™ COVID-19 test carried out by nurses in an emergency department in comparison with the reference PCR test: Simplexa ™ COVID-19 Direct | Sensitivity of the ID Now ™ COVID-19 Test Compared to the Simplexa ™ COVID-19 Direct Assay | Day 1 |
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