Coronavirus Disease 2019NCT04673279
Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina
An observational study of Coronavirus Disease 2019, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- serology
- How many people
- 189 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Dec 2020to 20 Aug 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- deny consent
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Niños Ricardo Gutierrez
Buenos Aires, Buenos Aires F.D., C1425EFD
About this study
Official title: Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina
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.
Read the 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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- serology
- Keywords
- Immunity, serology, antibody, SARS-CoV-2, COVID-19, vulnerability
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 20 weeks
Secondary outcomes (1)
to estimate the proportion of people with positive IgG antibodies for dengue
to estimate the proportion of people with positive IgG antibodies for dengue
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Dec 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 189 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Niños R. Gutierrez de Buenos Aires, Ministerio de Salud GCBA
- Responsible party
- Principal investigator, ALICIA MISTCHENKO, Hospital Italiano de Buenos Aires
- Investigators
- Vanina Pagotto, MD MG, Study chair, Hospital Italiano de Buenos AiresAlicia Mistchenko, Phd, Principal investigator, Hospital de Niños Ricardo GutierrezSilvana Figar, MD MG, Study chair, Hospital Italiano de Buenos AiresAndrea Gamarnick, Phd, Study chair, National Council of Scientific and Technical Research, ArgentinaAna Maria Gomez Saldaño, MD MG, Study chair, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos AiresLorena Luna, Study chair, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos AiresJulieta Salto, Study chair, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos AiresMagdalena Wagner Manslau, Study chair, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673279
- Sponsor's protocol ID
- 3545
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32217618Long 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.
PubMed 32555424Kellam 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.
PubMed 32430094Wilder-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.
PubMed 32539912Cardoso 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.
PubMed 15176983
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina
- ClinicalTrials.gov ID
- NCT04673279
- Acronym / sponsor ID
- 3545
- Conditions
- Coronavirus Disease 2019
- Keywords
- Immunity, serology, antibody, SARS-CoV-2, COVID-19, vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Hospital de Niños R. Gutierrez de Buenos Aires, Ministerio de Salud GCBA
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- deny consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serologyAn 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. | Diagnostic test | – |
Primary outcome
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
Time frame: up to 20 weeks
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
1 secondary outcome
to estimate the proportion of people with positive IgG antibodies for dengue
Time frame: up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 32217618Jordan 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.
- Background: PubMed 32555424Long 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.
- Background: PubMed 32430094Kellam 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.
- Background: PubMed 32539912Wilder-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.
- Background: PubMed 15176983Cardoso 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.
- 2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical FeaturesLink provided by the sponsor.
- Community-level SARS-CoV-2 Seroprevalence Survey in urban slum dwellers of Buenos Aires City, Argentina: a participatory research.Link provided by the sponsor.
- Reductions in commuting mobility correlate with geographic differences in SARS-CoV-2 prevalence in New York CityLink provided by the sponsor.
- The COVID-19 pandemic should not jeopardize dengue controlLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanina Pagotto, MD MG study chair
Hospital Italiano de Buenos Aires
Alicia Mistchenko, Phd principal investigator
Hospital de Niños Ricardo Gutierrez
Silvana Figar, MD MG study chair
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673279, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.