Seroprevalence of Coronavirus Disease 2019 (COVID-19) Antibodies in a Vulnerable Neighbourhood, Buenos Aries Argentina

December 13, 2020 updated by: ALICIA MISTCHENKO, Hospital Italiano de Buenos Aires

Seroprevalence of Antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) in a Vulnerable Neighbourhood, Buenos Aries Argentina

Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported.

Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A community-level seroprevalence survey was conducted in a cross-sectional design during a Participatory Action Research (PAR).

Starter PAR team: researcher who developed the Elisa Test, virologist that perform the analysis of the test and physician that served as volunteer field epidemiologist at the surveillance system (DetectAr Barrio 31) offered technical cooperation to test people experiencing homelessness.

PAR-First step: A sample for convenience of homeless people was tested during 3 days in a popular dining room managed by a non-governmental organization. Samples were collected by a DetectAr nurse and a volunteer epidemiologist.

PAR-Second step: feasibility was determined by the DetectAr coordinators of the Community Health Division of the Ministry of Health and the 12 health community workers (HCWs) when two volunteer epidemiologists from a University Institute explained the field organization (sample technique, data collection and database entry) for obtaining a probabilistic sample of residents. The PAR process was a cornerstone for reaching the sample size.

PAR-Third step: A cross-sectional study for seroprevalence survey was carried out.

Sample size and sample method Sample size was calculated for a seroprevalence of 5% according to evidence. A two-stage random sampling method was applied. First level: sector of the slum, Second level: geographical areas determined by the Department of Statistic and Census. Thirty houses were selected at this level. People over 14 years old were tested at the front door of their houses.

Serological test An enzyme linked immunosorbent assay [ELISA] developed in Argentina, by a laboratory in Buenos Aires, Argentina, was used. Performance characteristics are a high specificity (>95%) and a high sensibility (>95%) for SARS-COV-2 IgG. The test detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike. Viral proteins were expressed in human cells. This kit has obtained regulatory approval by Argentina's national drug regulatory agency (ANMAT, National Administration for Drugs, Food and Medical Devices)[. Blood samples were collected in a capillary tube from a finger prick, taken at the front door of each house. All HCWs were trained and epidemiological data was entered in a database. Samples were processed and analyzed at the virology laboratory in a pediatric hospital of Buenos Aires.

Statistical analysis To obtain the weighted prevalence, sample dataset was expanded to that of the last census by 3 factors: at neighborhood level, at household level and at individual level. The calculation of expansion factors at the household level is the inverse of the joint probability of selecting the last sampling unit (a household). The expansion factors at the household level imply three types of adjustments. The first one is related with non-response (given that some households did not want to answer the survey); the second one corresponds to the projection of sample to the entire population, and the third one to calibration techniques with a final adjustment by groups of age and gender, using external information from population census. Therefore, calibration variables were people 14 year-old or more, grouped by sex and by intervals of age: 14-30; 31-45; 46-59; 60 and more.

Prevalence of IgG antibodies were adjusted using sampling weights and post-stratification to allow for differences in non-response rates based on age group, sex, and census-tract income.

As household members share exposure to COVID-19, thus the outcome (prevalence of COVID-19 IgG) should show some correlation within the household. To test clustering effect, a random effects logistic regression model (multilevel model) was applied as it includes the variation between clusters explicitly in the likelihood and therefore takes account of intracluster correlation.

Study Type

Observational

Enrollment (Actual)

873

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Caba
      • Buenos Aires, Caba, Argentina, 1425
        • Hospital de Niños Ricardo Gutiérrez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Barrio Mugica, Buenos Aires city, Argentina, This Barrio isone of the most overcrowded slums with more than 50.000 inhabitants, and almost 1500 people experiencing homelessness

Description

Inclusion Criteria:

  • All subjects of 14 years or more who accept to be test

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to establish the seroprevalence of SARS-CoV-2
Time Frame: up to 20 weeks
Prevalence of positive IgG for SARS-CoV-2
up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Hospital de Niños R. Gutierrez de Buenos Aires
Salud Comunitaria Ministerio de Salud GCBA

Investigators

  • Study Chair: Silvana Figar, MD MG, Hospital Italiano de Buenos Aires
  • Principal Investigator: Alicia Mistchenko, MD PHD, Hospital de Niños Ricardo Gutiérrez
  • Study Chair: Vanina L Pagotto, MD MG, Hospital Italiano de Buenos Aires
  • Study Chair: Andrea Gamarnik, PHD, National Council of Scientific and Technical Research, Argentina
  • Study Chair: Ana M Gomez Saldaño, MD MG, Salud Comunitaria Ministerio de Salud GCBA
  • Study Director: Fernan Quiroz, MD MG, Ministerio de Salud GCBA
  • Study Chair: Lorena Luna, MG, Salud Comunitaria Ministerio de Salud GCBA
  • Study Chair: Magdalena Wagner Manslau, Salud Comunitaria Ministerio de Salud GCBA
  • Study Chair: Julieta Salto, Salud Comunitaria Ministerio de Salud GCBA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

December 11, 2020

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 13, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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