NCT04673279

Brief Summary

Between June 10t h and July 1st, a cross-sectional design study in an Argentina slum, showed a prevalence based on immunoglobuling G-class (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) of 53.4%. It remains unanswered whether natural infection produces sustained antibodies. The aim of this study is to evaluate the presence of IgG antibodies for Coronavirus disease 2019 (COVID-19) after 5 months in inhabitants of Barrio 31 who consented the Seroprevalence Study for COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 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

December 2, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

December 13, 2020

Last Update Submit

August 23, 2021

Conditions

Keywords

ImmunityserologyantibodySARS-CoV-2COVID-19vulnerability

Outcome Measures

Primary Outcomes (1)

  • to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement

    to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement

    up to 20 weeks

Secondary Outcomes (1)

  • to estimate the proportion of people with positive IgG antibodies for dengue

    up to 20 weeks

Interventions

serologyDIAGNOSTIC_TEST

An enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein.

Eligibility Criteria

Age14 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

inhabitants of Barrio Mugica: men and women form 14 years of age or older who were included in the first seroprevalence study carried on between Between June 10t h and July 1st, and who have positive antibodies against severe acute respiratory syndrome coronavirus 2

You may qualify if:

  • Men and women form 14 years of age or older who were included in the seroprevalence study and who have positive antibodies against severe acute respiratory syndrome coronavirus 2

You may not qualify if:

  • deny consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Niños Ricardo Gutierrez

Buenos Aires, Buenos Aires F.D., C1425EFD, Argentina

Location

Related Publications (5)

  • Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020 Mar 26;368:m1198. doi: 10.1136/bmj.m1198. No abstract available.

    PMID: 32217618BACKGROUND
  • Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.

    PMID: 32555424BACKGROUND
  • Kellam P, Barclay W. The dynamics of humoral immune responses following SARS-CoV-2 infection and the potential for reinfection. J Gen Virol. 2020 Aug;101(8):791-797. doi: 10.1099/jgv.0.001439.

    PMID: 32430094BACKGROUND
  • Wilder-Smith A, Tissera H, Ooi EE, Coloma J, Scott TW, Gubler DJ. Preventing Dengue Epidemics during the COVID-19 Pandemic. Am J Trop Med Hyg. 2020 Aug;103(2):570-571. doi: 10.4269/ajtmh.20-0480. Epub 2020 Jun 15. No abstract available.

    PMID: 32539912BACKGROUND
  • Cardoso MR, Cousens SN, de Goes Siqueira LF, Alves FM, D'Angelo LA. Crowding: risk factor or protective factor for lower respiratory disease in young children? BMC Public Health. 2004 Jun 3;4:19. doi: 10.1186/1471-2458-4-19.

    PMID: 15176983BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blod samples for antibodies detection against dengue

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vanina Pagotto, MD MG

    Hospital Italiano de Buenos Aires

    STUDY CHAIR
  • Alicia Mistchenko, Phd

    Hospital de Niños Ricardo Gutierrez

    PRINCIPAL INVESTIGATOR
  • Silvana Figar, MD MG

    Hospital Italiano de Buenos Aires

    STUDY CHAIR
  • Andrea Gamarnick, Phd

    National Council of Scientific and Technical Research, Argentina

    STUDY CHAIR
  • Ana Maria Gomez Saldaño, MD MG

    Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

    STUDY CHAIR
  • Lorena Luna

    Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

    STUDY CHAIR
  • Julieta Salto

    Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

    STUDY CHAIR
  • Magdalena Wagner Manslau

    Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

    STUDY CHAIR
  • Fernan Quiroz, MD MG

    Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires

    STUDY DIRECTOR

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

December 13, 2020

First Posted

December 17, 2020

Study Start

December 2, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations