Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19

NCT05128656 | Withdrawn

• 2 other identifiers: APHP2012532020-A01833-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2). Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection. The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection

Conditions

COVID-19

Keywords

EHPAD employees; COVID-19; asymptomatic; humoral response

Outcome Measures

Primary Outcomes (1)

• rate of positive IgG serology

  positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees

  month 1-2 post infection

Secondary Outcomes (5)

• rate of positive IgG serology

  month 3-6 post infection

• rate of positive immunoglobulin M (IgM) serology

  month 1-2-3 and 6 post infection

• rate of neutralizing antibodies

  month 1-2-3 and 6 post infection

• questionnaire

  month 1-2-3 and 6 post infection

• re infection

  through study completion, an average of 8 months

Study Arms (2)

Cases

OTHER

SARS-Cov-2 asymptomatic nursing homes employees

Other: serology

Controls

OTHER

cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.

Other: serology

Interventions

serology OTHER

serology at M3 and serology at M6

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18.
• Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital
• Affiliated with a health insurance
• Informed information and consent
• Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff.
• Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
• Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever)
• Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu.
• Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
• COVID-19 symptoms defined by:
• At least two major signs of COVID-19 among: \> fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste.
• or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs.
• It is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs).

You may not qualify if:

• Refuse to participate or inability to obtain informed consent.
• under guardianship, curators
• negative SARS-COV-2 PCR
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut Pasteur: collaborator

Study Sites (1)

HOTEL DIEU Hospital

Paris, 75004, France

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Dominique Salmon, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Case control longitudinal study, Interventional minimal risk study

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 22, 2021
• Study Start: June 18, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)