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

• Conditions: Health Personnel; COVID-19; SARS-CoV 2
• Interventions: Diagnostic Test: Serologic SARS-CoV-2 screening

• Registration Number: NCT04387890
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28
• Study Start: 2020-06-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serologic Screening	Serologic SARS-CoV-2 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.

Primary Outcome Measures

Name	Time	Method
COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus	During 3 months follow up	Patients that has a positive result for IgM or IgG or PCR during follow up
Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel	Baseline at study inclussion	Patients that has a positive result for IgM or IgG at baseline first test
Incidence of reactivation/reinfection for COVID-19 in health personnel with a positive serology for SARS-CoV-2	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