Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19 (SERASYMPTO)

Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study

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

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Other: serology

Detailed Description

The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, 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 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 main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.

Secondary objectives are

• To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection
• To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection
• To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)
• To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro
• To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.

The design will be a case control study between

• Cases: SARS-Cov-2 asymptomatic nursing homes employees
• Controls: 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75004
    • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Common inclusion criteria:

  • 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

• Inclusion Criteria for Cases (asymptomatic COVID-19 patients) :

  • 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)

• Inclusion criteria for controls (symptomatic COVID-19 patients) :

  • 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).

*Exclusion criteria :

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cases; SARS-Cov-2 asymptomatic nursing homes employees	Other: serology; serology at M3 and serology at M6
Other: Controls; 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; serology at M3 and serology at M6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of positive IgG serology	positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees	month 1-2 post infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of positive IgG serology	positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees	month 3-6 post infection
rate of positive immunoglobulin M (IgM) serology	positive IgM SARS-Cov-2 serology after infection of asymptomatic employees	month 1-2-3 and 6 post infection
rate of neutralizing antibodies	concentration of neutralizing antibodies	month 1-2-3 and 6 post infection
questionnaire	Associated factors with the presence of antibodies	month 1-2-3 and 6 post infection
re infection	of asymptomatic patients with SARS-Cov-2	through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut Pasteur
• Investigators: Principal Investigator: Dominique Salmon, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2022
• Primary Completion (Actual): June 18, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; asymptomatic; humoral response; EHPAD employees
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: APHP201253; 2020-A01833-36 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No