Clinical trial NCT04673279: Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina
Official title: Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019
Keywords: Immunity
serology
antibody
SARS-CoV-2
COVID-19
vulnerability
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Hospital de Niños R. Gutierrez de Buenos Aires
name: Ministerio de Salud GCBA
First posted: 2020-12-17
Enrollment: 189
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 20 weeks
Secondary outcomes:
measure: to estimate the proportion of people with positive IgG antibodies for dengue
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Niños Ricardo Gutierrez
state: Ciudad De Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Vanina Pagotto, MD MG
role: STUDY_CHAIR
affiliation: Hospital de Niños Ricardo Gutierrez
name: Alicia Mistchenko, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Silvana Figar, MD MG
role: STUDY_CHAIR
affiliation: National Council of Scientific and Technical Research, Argentina
name: Andrea Gamarnick, Phd
role: STUDY_CHAIR
affiliation: Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
name: Ana Maria Gomez Saldaño, MD MG
role: STUDY_CHAIR
affiliation: Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
name: Lorena Luna
role: STUDY_CHAIR
affiliation: Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
name: Julieta Salto
role: STUDY_CHAIR
affiliation: Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
name: Magdalena Wagner Manslau
role: STUDY_CHAIR
affiliation: Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
name: Fernan Quiroz, MD MG
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.