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Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care Workers

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: NCT04387890
Recruitment Status : Unknown
Verified May 2020 by Diego Hernan Giunta, PhD, MPH, MD, Hospital Italiano de Buenos Aires.
Recruitment status was:  Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Diego Hernan Giunta, PhD, MPH, MD, Hospital Italiano de Buenos Aires

Study Description
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Brief Summary:
The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.

Condition or disease Intervention/treatment
COVID-19 SARS-CoV 2 Health Personnel Diagnostic Test: Serologic SARS-CoV-2 screening

Detailed Description:
SARS-CoV-2 infection in healthcare workers (HCW) is nowadays a frequent problem for patient care and organization of care teams. SARS-CoV-2 antibody assessment provides a tool to evaluate antibody prevalence in hospital staff identifying previously exposed individuals. Serologic testing could identify new cases of COVID-19 in an early fashion and could help to investigate cases of reactivation or reinfection in hospital workers. The study purpose is to conduct a study using serological screening for health care workers in a University Hospital in Buenos Aires in order to assess the risk of COVID-19 on those who have not developed an immune response against the virus, or to detect it in an early fashion (either pre-symptomatic or asymptomatic). If a study participant is suspected to have potential reinfection or reactivation of COVID-19, the investigators will conduct genome sequencing in order to be able to differentiate each case. The investigators will include 50 participants chosen at random among health care workers from the hospital Emergency Department (ED), Internal Medicine wards, or Critical Care Units who are exposed to COVID-19. Participants who agree to join the study and sign the informed consent form will be screened at baseline for SARS-CoV-2 IgM and IgG antibodies, along with a physical exam and basic laboratory determinations. They will be re-screened with antibodies every 2 weeks for a total of 3 months. If they contract COVID-19, antibody determinations and nasopharyngeal swabs will be carried out in order to identify those who are in favorable conditions to return to work. The main objective is to prospectively determine the incidence of COVID-19, Anti SARS-CoV-2 antibody prevalence, and incidence of SARS-CoV-2 reinfection or reactivation of COVID-19 in a health care workers cohort.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Serologic Screening
Participants will be screened for IgM and IgG SARS-CoV-2 antibodies at baseline and every 2 weeks. Participants showing symptoms compatible with COVID-19 will undergo nasopharyngeal swab for PCR testing for diagnosis. Participants recovered from COVID-19 will have to have 2 negative and consecutive nasopharyngeal swab PCR tests in order to return to work.
 Diagnostic Test: Serologic SARS-CoV-2 screening
Quantitative Indirect Chemiluminescence Immunoassay (CLIA) to access SARS-CoV-2 specific IgM and IgG serum antibody level every 2 weeks during follow up


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel [ Time Frame: Baseline at study inclussion ]
    Patients that has a positive result for IgM or IgG at baseline first test

  2. COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus [ Time Frame: During 3 months follow up ]
    Patients that has a positive result for IgM or IgG or PCR during follow up

  3. Incidence of reactivation/reinfection for COVID-19 in health personnel with a positive serology for SARS-CoV-2 [ Time Frame: During 3 months follow up ]
    Patients with confirmed previous SARS Cov 2 antibodies that reactivate symptomons or new increase in antibodies title during follow up


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Physicians directed involved with the healthcare of COVID-19 patients
Criteria

Inclusion Criteria:

  1. Healthcare staff (Physicians) AND
  2. Directly involved in care of patients with confirmed or suspected COVID-19 AND
  3. Working in any of the two hospital venues (Hospital Italiano Central and Hospital Italiano San Justo Agustín Rocca).

Exclusion Criteria:

  1. Refusal to sign the Informed Consent Form OR
  2. Experienced symptoms compatible with COVID-19 in the last 14 days prior to eligibility screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387890


Contacts
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Contact: Ines Staneloni, MD +54 011 4959 0200 maria.staneloni@hospitalitaliano.org.ar
Contact: Cristina Elizondo, MD cristina.elizondo@hospitalitaliano.org.ar

Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Roche Pharma AG
Investigators
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Principal Investigator: Leticia Peroni, MD HIBA
Principal Investigator: Vanina Stanek, MD HIBA
Principal Investigator: Diego Sanchez Thomas, MD HIBA
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Diego Hernan Giunta, PhD, MPH, MD, MD, MPH, University SoTL, PhD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04387890    
Other Study ID Numbers: 5566
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diego Hernan Giunta, PhD, MPH, MD, Hospital Italiano de Buenos Aires:
SARS Virus
SARS-CoV-2
COVID-19
Health Personnel
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases