- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04673279
Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina
Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background Between June 10t h and July 1st, a cross-sectional design study was carried out in an Argentina slum over people, selected from a probabilistic sample of households showed a prevalence based on IgG-class antibodies against SARS-CoV-2 of 53.4%. In regarding to the persistence of these antibodies, the early data brought hope that acquired immunity was possible. But some subsequent studies have suggested that immune protection might be short-lived. The new findings show that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms. In contrast, some other antibody types decline more quickly.
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ciudad De Buenos Aires
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Buenos Aires, Ciudad De Buenos Aires, Argentina, C1425EFD
- Hospital de Niños Ricardo Gutiérrez
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- deny consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Trasversale
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: up to 20 weeks
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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
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up to 20 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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to estimate the proportion of people with positive IgG antibodies for dengue
Lasso di tempo: up to 20 weeks
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to estimate the proportion of people with positive IgG antibodies for dengue
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up to 20 weeks
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Vanina Pagotto, MD MG, Hospital Italiano de Buenos Aires
- Investigatore principale: Alicia Mistchenko, Phd, Hospital de Niños Ricardo Gutiérrez
- Cattedra di studio: Silvana Figar, MD MG, Hospital Italiano de Buenos Aires
- Cattedra di studio: Andrea Gamarnick, Phd, National Council of Scientific and Technical Research, Argentina
- Cattedra di studio: Ana Maria Gomez Saldaño, MD MG, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- Cattedra di studio: Lorena Luna, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- Cattedra di studio: Julieta Salto, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- Cattedra di studio: Magdalena Wagner Manslau, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- Direttore dello studio: Fernan Quiroz, MD MG, Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
Pubblicazioni e link utili
Pubblicazioni generali
- 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. Review.
- 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.
- Cardoso MR, Cousens SN, de Góes 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.
Collegamenti utili
- 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
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Altri numeri di identificazione dello studio
- 3545
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