Clinical Trials Logo

Clinical Trial Summary

Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.


Clinical Trial Description

The first cases of the new coronavirus disease 2019 (COVID-19) due to the SARS-CoV-2 virus were reported in December 2019 in Wuhan, China. Since that date, a significant circulation of the virus around the world has been observed, justifying that WHO described the situation as pandemic on March 11. Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization. In the general population, only one recent study in France, in the Oise, one of the first clusters in France, reports a seroconversion rate of 35% in the area concerned [7]. This study used three different tests (ELISA, S-FLOW, LIPS assays) to define seroconversion (people were considered positive if at least one of the tests reported the presence of Anti SARS CoV 2 Antibodies). The proportion of people infected in Brittany, estimated by modeling work, would be 1.8% [1.1% -3.3%]. At the present time, no data exist to our knowledge on the seroprevalence of anti SARS-CoV-2 antibodies in healthcare populations. Many serological tests are currently being validated. The Rennes University Hospital, thanks to the support of the NOMINOE fund, will offer all employees of the territory hospital group (GHT) Haute-Bretagne to participate in this seroprevalence study using the serological test from the company NG-Biotech. It is a device of the type "rapid serological diagnostic orientation test (TROD)" which can be carried out outside medical biology laboratories by a doctor / pharmacist who is not a biologist or a nurse. This test provides a result in about fifteen minutes. The NG-Biotech test has a CE / IVD mark (pending opinion from the Institut Pasteur). An assessment of the sensitivity and specificity of the test was carried out at the CHU Kremlin Bicêtre and CHU Paul Brousse. From a sample of 101 COVID-19 patients (diagnosed by RT-PCR on nasopharyngeal or pulmonary samples) and 50 negative controls (30 pre-pandemic sera from September and October 2017 and 20 sera from patients tested COVID- 19 negative by RT-PCR without any symptoms for more than 15 days) a sensitivity of 97% [88.7% - 99.4%] and a specificity of 100% [91.1% -100%] were obtained 15 days after the first signs of COVID-19 patients. If the validity of the test is very good in this study, its main limitation is that it was carried out with a group of COVID-19 patients who were in the vast majority hospitalized (84% of patients) and therefore not representative of pauci or asymptomatic patients . Consequently, given the absence of consolidated data on the immune response based on clinical pictures, it is relevant to continue validation in a population of employees in which we wish to carry out this seroprevalence study and where the majority of infections did not lead to hospitalization. In addition, it is also necessary to obtain other data, in particular concerning the inter-observer reproducibility of the test which has not yet been studied. The need to validate the test in pauci or asymptomatic populations and to obtain reproducibility data was underlined in the opinion of the HAS on the methods for evaluating the performance of serological tests detecting antibodies directed against SARS-CoV -2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04416308
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase N/A
Start date May 29, 2020
Completion date October 12, 2020

See also
  Status Clinical Trial Phase
Completed NCT05065827 - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting NCT05359770 - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT06025812 - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) N/A
Recruiting NCT05289115 - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS N/A
Completed NCT04953078 - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 Phase 1
Completed NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Not yet recruiting NCT05868239 - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study N/A
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Recruiting NCT04772170 - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Completed NCT05572840 - Wear Your Mask, Wash Your Hands, Don't Get COVID-19 N/A
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3
Completed NCT04556149 - imPulseā„¢ Una Full-spectrum, Over Clothing E-stethoscope