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

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.

Unknown status
COVID-19
SARS-CoV 2
Health Personnel

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

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Contacts

Ines Staneloni, MD
+54 011 4959 0200
maria.staneloni@hospitalitaliano.org.ar

Roche Pharma AG
NCT Number
Keywords
SARS Virus
SARS-CoV-2
Covid-19
Health Personnel
MeSH Terms
COVID-19