Detection of Anti-COVID-19 Antibody Levels in an Hospital Population

Observational Cohort Study for the Detection of Anti-COVID-19 Antibody Levels in an Hospital Population

COVID-19 (SARS-CoV-2) infection in health professionals represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow. The objective of the study is to evaluate the spread of COVID-19 virus within the hospital population of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR in the subgroup positive to IgG antibodies.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Detection of anti-COVID-19 antibody level

Detailed Description

The Coronavirus identified in Wuhan, China, for the first time in late 2019 is a new viral strain that has never previously been identified in humans. It has been called SARS-CoV-2 and the respiratory disease that causes COVID-19. SARS-CoV-2 infection in health professionals has represented and continues to represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow.

Currently the gold standard for the non-invasive diagnosis of COVID-19 is the detection of the viral genome by RT-PCR. However, despite the high specificity, this technique has a low sensitivity and can produce false negative samples. Furthermore, detection of the viral genome is indicative of active infection and fails to identify subjects previously exposed to the virus who have passed the infection asymptomatically. Serological tests can detect the presence of anti-SARS-CoV-2 antibodies in blood or serum samples and, depending on the type of antibody detected, identify the subjects in the active phase of the infection and after the resolution of the infection, the whose diagnosis was not made by performing a swab.

We will evaluate the actual spread of the SARS-CoV-2 virus within the hospital personnel of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR of nasopharyngeal swabs in the subgroup positive to IgG antibodies. Secondary endpoints are: visualize the trend of the antibody value at 3, 6 and 12 months; correlation between the antibody titer in test positive subjects and the viral load of the nasopharyngeal swab; identification of predictive variables of susceptibility to viral SARS-CoV2 infection.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Rozzano, Lombardia, Italy, 20089
      • Recruiting
      • Humanitas Rozzano/San Pio X
      • Contact: Patrizia Meroni, MD; Phone Number: 0282241; Email: patrizia.meroni@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Personnel of Humanitas Group including:

Healthcare Staff (Doctors, Nurses, OSS) Technical Staff (Biologists, Radiology Technicians, Laboratory Technicians, etc.) PARC staff and Staff Staff Research Internship students of Hunimed Contract staff (e.g. transport and sanitation services)

Description

Inclusion Criteria:

• Age> 18 years old
• work for the Humanitas Group (Rozzano / San Pio X, Humanitas Gavazzeni, Humanitas Mater Domini, Humanitas University, Humanitas Medical Care)
• Work activity in the Humanitas Group for at least 3 months among which, for example:

Healthcare Staff (Doctors, Nurses, OSS) Technical Staff (Biologists, Radiology Technicians, Laboratory Technicians, etc.) PARC staff and Staff Staff Research Internship students of Hunimed Contract staff (e.g. transport and sanitation services)

• Signature of informed consent
• Compilation of the anamnestic questionnaire

Exclusion Criteria:

• Subjects absent for any reason during the study period

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IgG negative; No intervantion. Only antibody mesurment from blood sample	Diagnostic test: Detection of anti-COVID-19 antibody level; Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.
IgG positive, viral load negative; No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs	Diagnostic test: Detection of anti-COVID-19 antibody level; Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.
IgG positive, viral load positive; No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs	Diagnostic test: Detection of anti-COVID-19 antibody level; Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 levels of IgG antibodies	Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects	Measurement of the viral load of the nasopharyngeal swab in antibody test positive subjects and the correlation between the antibody titer and virus positivity or negativity.	1 year
Epidemiology correlations	The association between the antibody value and potential protective or risk factors of the subject participating in the study such as age, clinical history, vaccination history, workplace, professional category, etc.	1 year

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Publications and helpful links

General Publications

• Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, Rescigno M. One dose of SARS-CoV-2 vaccine exponentially increases antibodies in individuals who have recovered from symptomatic COVID-19. J Clin Invest. 2021 Jun 15;131(12):e149154. doi: 10.1172/JCI149154.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Antibody titer; Serological tests; Hospital personnel
• 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; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 1374 IgG COVID-19 HUMANITAS

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