Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina

Coronavirus Disease 2019 Clinical Trial

Official title:

Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673279
• Other study ID #: 3545
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: August 2021
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Argentina	Hospital de Niños Ricardo Gutierrez	Buenos Aires	Ciudad De Buenos Aires

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Hospital de Niños R. Gutierrez de Buenos Aires, Ministerio de Salud GCBA

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

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. — View Citation

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to estimate the proportion of people with positive IgG antibodies for dengue	to estimate the proportion of people with positive IgG antibodies for dengue	up to 20 weeks

External Links

•   2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical Features
•   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
•   SARS-CoV-2 infection induces sustained humoral immune responses in convalescent patients following symptomatic COVID-19
•   The COVID-19 pandemic should not jeopardize dengue control