Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina
NCT ID: NCT04673279
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
189 participants
OBSERVATIONAL
2020-12-02
2021-08-20
Brief Summary
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Detailed Description
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It remains unanswered whether natural infection produces a sustained immunity that is capable of establishing herd immunity. The other health problem that Latin America faces is dengue, whose transmission, like SARS-CoV-2, is greater in areas with high population density such as vulnerable neighborhoods. In this context, the occurrence of the two diseases implies a risk, particularly in regions with several dengue serotypes where secondary and tertiary infections have been demonstrated and dengue epidemiological surveillance has been affected by the saturation of health system.
Objectives The aim of this study is to evaluate the presence of IgG antibodies for COVID-19 after 5 months in inhabitants of this slum who consented the Seroprevalence Study for COVID-19, and to evaluate those factors associated with the persistence of positive antibodies. As a secondary objective, the presence of positive IgG for dengue will be evaluated.
Methods Cross sectional study. Population of the study were inhabitants of the slum: men and women form 14 years of age or older were included. People will be invited to participated and detection of antibodies will be performed with ta serological tests, 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. Blood sample will be collected in a capillary tube from a finger prick taken at the doorstep of each person. Samples will be processed and analyzed at the "Hospital de Niños Doctor Ricardo Gutierrez" Virology laboratory.
Blood sample collection and epidemiological data were collected, and entered in a secure database.
Sample Size The first seroprevalence study included 426 inhabitants of 14 years or more. Considering a persistence of antibodies of 30% with a precision of 5% for a confidence interval of 95% 184 inhabitants should be included. This sample will be selected by a proportionate stratified random sampling, considering the ten sectors in which the slum is divided.
Statistical analysis Descriptive statistics of the data will be carried out according to the variables obtained. Continuous variables will be expressed as mean and standard deviation, and categorical variables as proportions. A multiple logistic regression model will be performed to evaluate the factors associated with the persistence of positive antibodies for SARS-CoV-2.
Dengue seroprevalence is determined globally and by geographic sector. R software version 4.0.2 will be used.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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serology
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
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Inclusion Criteria
Exclusion Criteria
14 Years
90 Years
ALL
No
Sponsors
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Hospital de Niños R. Gutierrez de Buenos Aires
OTHER
Ministerio de Salud GCBA
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
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ALICIA MISTCHENKO
principal investigator
Principal Investigators
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Vanina Pagotto, MD MG
Role: STUDY_CHAIR
Hospital Italiano de Buenos Aires
Alicia Mistchenko, Phd
Role: PRINCIPAL_INVESTIGATOR
Hospital de Niños Ricardo Gutierrez
Silvana Figar, MD MG
Role: STUDY_CHAIR
Hospital Italiano de Buenos Aires
Andrea Gamarnick, Phd
Role: STUDY_CHAIR
National Council of Scientific and Technical Research, Argentina
Ana Maria Gomez Saldaño, MD MG
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Lorena Luna
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Julieta Salto
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Magdalena Wagner Manslau
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Fernan Quiroz, MD MG
Role: STUDY_DIRECTOR
Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Locations
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Hospital de Niños Ricardo Gutierrez
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical Features
SARS-CoV-2 infection induces sustained humoral immune responses in convalescent patients following symptomatic COVID-19
Community-level SARS-CoV-2 Seroprevalence Survey in urban slum dwellers of Buenos Aires City, Argentina: a participatory research.
Reductions in commuting mobility correlate with geographic differences in SARS-CoV-2 prevalence in New York City
The COVID-19 pandemic should not jeopardize dengue control
Other Identifiers
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3545
Identifier Type: -
Identifier Source: org_study_id
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