Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04387838
Other study ID # 2020-COVID19-10
Secondary ID 2020-A01028-31
Status Completed
Phase
First received
Last updated
Start date May 14, 2020
Est. completion date August 15, 2020

Study information

Verified date March 2021
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3. Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced. This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.


Recruitment information / eligibility

Status Completed
Enrollment 845
Est. completion date August 15, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 62 Years
Eligibility Inclusion Criteria: - Army Training Hospital staff Exclusion Criteria: - Individuals who have already been confirmed Covid-19 positive - Individuals taking preventive anti-Covid-19 therapy or considering participating in anti-Covid-19 therapy study - Individuals on hydroxychloroquine - Pregnant or breastfeeding women - Non-permanent staff during the study period - Individuals identified for a detachment outside the metropole during the study period

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Anti-SARS-CoV2 Serology
A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.
Other:
Questionnaire
Data concerning personal exposure factors are collected in a questionnaire: Socio-demographic factors: sex, age Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures

Locations

Country Name City State
France Hôpital d'Instuction des Armées Sainte-Anne Toulon
France Hôpital d'Instruction des Armées Robert Picqué Villenave-d'Ornon

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-SARS-Cov2 seroconversion between Day 0 and Day 60. Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample. From Day 0 to Day 60
Primary Anti-SARS-Cov2 seroconversion between Day 0 and Day 30. Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample. From Day 0 to Day 30
Primary Anti-SARS-Cov2 seroconversion between Day 30 and Day 60. Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample. From Day 30 to Day 60
Secondary Anti-SARS-Cov2 seroprevalence at Day 0. Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0. Day 0
Secondary Correlation between seroconversion and socio-demographic factors - sex Correlation between seroconversion (measured in blood sample) at Day 60 and sex Day 60
Secondary Correlation between seroconversion and socio-demographic factors - age Correlation between seroconversion (measured in blood sample) at Day 60 and age Day 60
Secondary Correlation between seroconversion and professional factors - job type Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.) Day 60
Secondary Correlation between seroconversion and professional factors - personal protective equipment type Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type Day 60
Secondary Correlation between seroconversion and non-professional factors - contact with infected individuals Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals Day 60
Secondary Correlation between seroconversion and non-professional factors - wearing of professional equipment Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment Day 60
Secondary Correlation between seroconversion and non-professional factors - respect of barrier gestures Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures Day 60
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04446065 - Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers Phase 2/Phase 3
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Not yet recruiting NCT04400019 - Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) Phase 2/Phase 3
Completed NCT04463004 - Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation Phase 2
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2
Recruiting NCT04581148 - SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)
Recruiting NCT04441372 - Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection
Terminated NCT04371978 - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 Phase 3
Completed NCT04530604 - Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS) Phase 1
Active, not recruiting NCT04635605 - Methylene Blue Treatment of COVID-19 Phase 2
Recruiting NCT04395599 - Risk of Air Contamination During Visceral Surgery in COVID19 Patients N/A
Recruiting NCT04472585 - Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients Phase 1/Phase 2
Active, not recruiting NCT04411433 - Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19 Phase 3
Completed NCT04359706 - Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
Recruiting NCT04395794 - SARS-CoV-2 Disguise Study
Completed NCT04386551 - Detection of COVID-19 in Saliva Collection
Recruiting NCT04403269 - NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE Phase 2
Withdrawn NCT04379492 - A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19 Phase 2
Completed NCT04366934 - Study of the Pathogenesis of Olfactory Disorders in COVID-19