Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities

NCT05011344 | Unknown

• 1 other identifier: 2020-39
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

Conditions

Covid19

Keywords

serology; healthcare workers

Outcome Measures

Primary Outcomes (1)

• To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers

  Positive seroneutralization test result: the threshold of positivity is set at 40, i.e. any serum with a seroneutralizing value greater than or equal to 40 will be considered positive.

  4, 8 and 12 months follow-up visits after the initial visit

Secondary Outcomes (5)

• Kinetics of the protective antibody immune response (protective immunization against SARS-CoV-2 COVID-19) in a population of exposed hospital workers over a 12-month period.

  4, 8 and 12 months follow-up visits after the initial visit

• Compare immunization profiles

  12 months after the initial visit

• Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).

  4, 8 and 12 months follow-up visits after the initial visit

• Identify the technical (sensitivity and specificity) and predictive (positive and negative predictive values) characteristics of the ELISA test evaluated in comparison with the reference test (serum neutralization) in the population of interest.

  12 months

• Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.

  4, 8 and 12 months follow-up visits after the initial visit

Study Arms (2)

Exposed hospital staff

EXPERIMENTAL

Hospital health care or non-health care staff willing to participate in the study: * Healthcare personnel (physician, nurse, caregiver) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, radiology, COVID-19 units; * Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection.

Other: Blood sample

'Non-exposed' hospital workers

OTHER

Hospital health care worker (physician, nurse, caregiver) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.

Other: Blood sample

Interventions

Blood sample OTHER

Seroneutralization and Elisa tests

'Non-exposed' hospital workers; Exposed hospital staff

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort of exposed hospital workers
• \- Hospital caregiver or non-clinician agreeing to participate in the study defined as: Healthcare personnel (physician, nurse, orderly, physical therapist, midwives) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, COVID-19 units;
• Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection
• Person affiliated to a social security system
• Cohort of 'unexposed' hospital workers
• Hospital care worker (physician, nurse, orderly) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.
• Person affiliated with a social security system

You may not qualify if:

• Hospital worker declining to participate If the hospital worker changes assignment after the first collection, he/she remains in the exposed cohort.
• Protected adult
• Person under legal guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie GARRIDO-PRADALIE, MD

  APHM

  STUDY DIRECTOR

Central Study Contacts

Laetitia Ninove, MCU-PH

CONTACT

+33 4 91 83 20 66; Laetitia.Ninove@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 18, 2021
• Study Start: July 15, 2020
• Primary Completion: July 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

FR (1)