NCT04472078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
873

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

16 days

First QC Date

July 12, 2020

Last Update Submit

December 13, 2020

Conditions

Keywords

SlumsSeroprevalence studyParticipatory ResearchCoronavirusCommunity healthClustering

Outcome Measures

Primary Outcomes (1)

  • to establish the seroprevalence of SARS-CoV-2

    Prevalence of positive IgG for SARS-CoV-2

    up to 20 weeks

Interventions

Serological Assay for detection of IgG for SARS-CoV-2

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Niños Ricardo Gutierrez

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

Related Publications (9)

  • Sood N, Simon P, Ebner P, Eichner D, Reynolds J, Bendavid E, Bhattacharya J. Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Los Angeles County, California, on April 10-11, 2020. JAMA. 2020 Jun 16;323(23):2425-2427. doi: 10.1001/jama.2020.8279.

    PMID: 32421144BACKGROUND
  • Pereira RJ, Nascimento GNLD, Gratao LHA, Pimenta RS. The risk of COVID-19 transmission in favelas and slums in Brazil. Public Health. 2020 Jun;183:42-43. doi: 10.1016/j.puhe.2020.04.042. Epub 2020 May 8. No abstract available.

    PMID: 32422438BACKGROUND
  • Corburn J, Vlahov D, Mberu B, Riley L, Caiaffa WT, Rashid SF, Ko A, Patel S, Jukur S, Martinez-Herrera E, Jayasinghe S, Agarwal S, Nguendo-Yongsi B, Weru J, Ouma S, Edmundo K, Oni T, Ayad H. Slum Health: Arresting COVID-19 and Improving Well-Being in Urban Informal Settlements. J Urban Health. 2020 Jun;97(3):348-357. doi: 10.1007/s11524-020-00438-6.

    PMID: 32333243BACKGROUND
  • Moen EL, Fricano-Kugler CJ, Luikart BW, O'Malley AJ. Analyzing Clustered Data: Why and How to Account for Multiple Observations Nested within a Study Participant? PLoS One. 2016 Jan 14;11(1):e0146721. doi: 10.1371/journal.pone.0146721. eCollection 2016.

    PMID: 26766425BACKGROUND
  • Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci. 2010 Aug 11;30(32):10601-8. doi: 10.1523/JNEUROSCI.0362-10.2010.

    PMID: 20702692BACKGROUND
  • Aarts E, Verhage M, Veenvliet JV, Dolan CV, van der Sluis S. A solution to dependency: using multilevel analysis to accommodate nested data. Nat Neurosci. 2014 Apr;17(4):491-6. doi: 10.1038/nn.3648. Epub 2014 Mar 26.

    PMID: 24671065BACKGROUND
  • Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.

    PMID: 32543763BACKGROUND
  • Theel ES, Slev P, Wheeler S, Couturier MR, Wong SJ, Kadkhoda K. The Role of Antibody Testing for SARS-CoV-2: Is There One? J Clin Microbiol. 2020 Jul 23;58(8):e00797-20. doi: 10.1128/JCM.00797-20. Print 2020 Jul 23.

    PMID: 32350047BACKGROUND
  • Buckley RM. Targeting the World's Slums as Fat Tails in the Distribution of COVID-19 Cases. J Urban Health. 2020 Jun;97(3):358-364. doi: 10.1007/s11524-020-00450-w.

    PMID: 32488763BACKGROUND

Related Links

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Alicia Mistchenko, MD PHD

    Hospital de Niños Ricardo Gutierrez

    PRINCIPAL INVESTIGATOR
  • Vanina L Pagotto, MD MG

    Hospital Italiano de Buenos Aires

    STUDY CHAIR
  • Silvana Figar, 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 CHAIR
  • Fernan Quiroz, MD MG

    Ministerio de Salud GCBA

    STUDY DIRECTOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 15, 2020

Study Start

June 10, 2020

Primary Completion

June 26, 2020

Study Completion

December 11, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations