Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387929
Recruitment Status : Unknown
Verified May 2020 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : May 14, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Tracking Information
First Submitted Date May 13, 2020
First Posted Date May 14, 2020
Last Update Posted Date May 15, 2020
Actual Study Start Date May 4, 2020
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2020)
SARS-CoV-2 levels of IgG antibodies [ Time Frame: 1 year ]
Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 13, 2020)
  • SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects [ Time Frame: 1 year ]
    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.
  • Epidemiology correlations [ Time Frame: 1 year ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
Official Title Observational Cohort Study for the Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
Brief Summary 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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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)

Condition COVID-19
Intervention 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.
Study Groups/Cohorts
  • IgG negative
    No intervantion. Only antibody mesurment from blood sample
    Intervention: Diagnostic Test: Detection of anti-COVID-19 antibody level
  • IgG positive, viral load negative
    No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
    Intervention: Diagnostic Test: Detection of anti-COVID-19 antibody level
  • IgG positive, viral load positive
    No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
    Intervention: Diagnostic Test: Detection of anti-COVID-19 antibody level
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). pii: 149154. doi: 10.1172/JCI149154.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 13, 2020)
6000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04387929
Other Study ID Numbers 1374 IgG COVID-19 HUMANITAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Istituto Clinico Humanitas
Original Responsible Party Same as current
Current Study Sponsor Istituto Clinico Humanitas
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Clinico Humanitas
Verification Date May 2020