SARS-CoV-2NCT04472078
Seroprevalence of Coronavirus Disease 2019 (COVID-19) Antibodies in a Vulnerable Neighbourhood, Buenos Aries Argentina
An observational study of SARS-CoV-2, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported. Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Serological Assay or IgG for SARS-CoV-2
- How many people
- 873 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Jun 2020to 11 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Barrio Mugica, Buenos Aires city, Argentina, This Barrio isone of the most overcrowded slums with more than 50.000 inhabitants, and almost 1500 people experiencing homelessness
Who may be able to join
- All subjects of 14 years or more who accept to be test
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Niños Ricardo Gutierrez
Buenos Aires, Buenos Aires F.D., 1425
About this study
Official title: Seroprevalence of Antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) in a Vulnerable Neighbourhood, Buenos Aries Argentina
Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported.
Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test
Read the detailed description
A community-level seroprevalence survey was conducted in a cross-sectional design during a Participatory Action Research (PAR).
Starter PAR team: researcher who developed the Elisa Test, virologist that perform the analysis of the test and physician that served as volunteer field epidemiologist at the surveillance system (DetectAr Barrio 31) offered technical cooperation to test people experiencing homelessness.
PAR-First step: A sample for convenience of homeless people was tested during 3 days in a popular dining room managed by a non-governmental organization. Samples were collected by a DetectAr nurse and a volunteer epidemiologist.
PAR-Second step: feasibility was determined by the DetectAr coordinators of the Community Health Division of the Ministry of Health and the 12 health community workers (HCWs) when two volunteer epidemiologists from a University Institute explained the field organization (sample technique, data collection and database entry) for obtaining a probabilistic sample of residents. The PAR process was a cornerstone for reaching the sample size.
PAR-Third step: A cross-sectional study for seroprevalence survey was carried out.
Sample size and sample method Sample size was calculated for a seroprevalence of 5% according to evidence. A two-stage random sampling method was applied. First level: sector of the slum, Second level: geographical areas determined by the Department of Statistic and Census. Thirty houses were selected at this level. People over 14 years old were tested at the front door of their houses.
Serological test An enzyme linked immunosorbent assay [ELISA] developed in Argentina, by a laboratory in Buenos Aires, Argentina, was used. Performance characteristics are a high specificity (>95%) and a high sensibility (>95%) for SARS-COV-2 IgG. The test detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike. Viral proteins were expressed in human cells. This kit has obtained regulatory approval by Argentina's national drug regulatory agency (ANMAT, National Administration for Drugs, Food and Medical Devices)[. Blood samples were collected in a capillary tube from a finger prick, taken at the front door of each house. All HCWs were trained and epidemiological data was entered in a database. Samples were processed and analyzed at the virology laboratory in a pediatric hospital of Buenos Aires.
Statistical analysis To obtain the weighted prevalence, sample dataset was expanded to that of the last census by 3 factors: at neighborhood level, at household level and at individual level. The calculation of expansion factors at the household level is the inverse of the joint probability of selecting the last sampling unit (a household). The expansion factors at the household level imply three types of adjustments. The first one is related with non-response (given that some households did not want to answer the survey); the second one corresponds to the projection of sample to the entire population, and the third one to calibration techniques with a final adjustment by groups of age and gender, using external information from population census. Therefore, calibration variables were people 14 year-old or more, grouped by sex and by intervals of age: 14-30; 31-45; 46-59; 60 and more.
Prevalence of IgG antibodies were adjusted using sampling weights and post-stratification to allow for differences in non-response rates based on age group, sex, and census-tract income.
As household members share exposure to COVID-19, thus the outcome (prevalence of COVID-19 IgG) should show some correlation within the household. To test clustering effect, a random effects logistic regression model (multilevel model) was applied as it includes the variation between clusters explicitly in the likelihood and therefore takes account of intracluster correlation.
- Conditions
- SARS-CoV-2
- Being tested
- Serological Assay or IgG for SARS-CoV-2
- Keywords
- Slums, Seroprevalence study, Participatory Research, Coronavirus, Community health, Clustering
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological Assay or IgG for SARS-CoV-2Diagnostic test
Serological Assay for detection of IgG for SARS-CoV-2
What is being measured
The primary outcome is the main question the study is designed to answer.
to establish the seroprevalence of SARS-CoV-2
Prevalence of positive IgG for SARS-CoV-2
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 posted15 Jul 2020
- Study start10 Jun 2020
- Primary completion26 Jun 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies 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
- 873 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, Salud Comunitaria Ministerio de Salud GCBA
- Responsible party
- Principal investigator, ALICIA MISTCHENKO, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Alicia Mistchenko, MD PHD, Principal investigator, Hospital de Niños Ricardo GutierrezVanina L Pagotto, MD MG, Study chair, Hospital Italiano de Buenos AiresSilvana Figar, MD MG, Study chair, Hospital Italiano de Buenos AiresAndrea Gamarnik, PHD, Study chair, National Council of Scientific and Technical Research, ArgentinaAna M Gomez Saldaño, MD MG, Study chair, Salud Comunitaria Ministerio de Salud GCBAFernan Quiroz, MD MG, Study director, Ministerio de Salud GCBALorena Luna, MG, Study chair, Salud Comunitaria Ministerio de Salud GCBAMagdalena Wagner Manslau, Study chair, Salud Comunitaria Ministerio de Salud GCBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472078
- Sponsor's protocol ID
- 1831
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Sood N, Simon P, Ebner P, Eichner D, Reynolds J, Bendavid E, Bhattacharya J. Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Los Angeles County, California, on April 10-11, 2020. JAMA. 2020 Jun 16;323(23):2425-2427. doi: 10.1001/jama.2020.8279.
PubMed 32421144Pereira RJ, Nascimento GNLD, Gratao LHA, Pimenta RS. The risk of COVID-19 transmission in favelas and slums in Brazil. Public Health. 2020 Jun;183:42-43. doi: 10.1016/j.puhe.2020.04.042. Epub 2020 May 8. No abstract available.
PubMed 32422438Corburn J, Vlahov D, Mberu B, Riley L, Caiaffa WT, Rashid SF, Ko A, Patel S, Jukur S, Martinez-Herrera E, Jayasinghe S, Agarwal S, Nguendo-Yongsi B, Weru J, Ouma S, Edmundo K, Oni T, Ayad H. Slum Health: Arresting COVID-19 and Improving Well-Being in Urban Informal Settlements. J Urban Health. 2020 Jun;97(3):348-357. doi: 10.1007/s11524-020-00438-6.
PubMed 32333243Moen EL, Fricano-Kugler CJ, Luikart BW, O'Malley AJ. Analyzing Clustered Data: Why and How to Account for Multiple Observations Nested within a Study Participant? PLoS One. 2016 Jan 14;11(1):e0146721. doi: 10.1371/journal.pone.0146721. eCollection 2016.
PubMed 26766425Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci. 2010 Aug 11;30(32):10601-8. doi: 10.1523/JNEUROSCI.0362-10.2010.
PubMed 20702692Aarts E, Verhage M, Veenvliet JV, Dolan CV, van der Sluis S. A solution to dependency: using multilevel analysis to accommodate nested data. Nat Neurosci. 2014 Apr;17(4):491-6. doi: 10.1038/nn.3648. Epub 2014 Mar 26.
PubMed 24671065Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.
PubMed 32543763Theel ES, Slev P, Wheeler S, Couturier MR, Wong SJ, Kadkhoda K. The Role of Antibody Testing for SARS-CoV-2: Is There One? J Clin Microbiol. 2020 Jul 23;58(8):e00797-20. doi: 10.1128/JCM.00797-20. Print 2020 Jul 23.
PubMed 32350047Buckley RM. Targeting the World's Slums as Fat Tails in the Distribution of COVID-19 Cases. J Urban Health. 2020 Jun;97(3):358-364. doi: 10.1007/s11524-020-00450-w.
PubMed 32488763
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) in a Vulnerable Neighbourhood, Buenos Aries Argentina
- ClinicalTrials.gov ID
- NCT04472078
- Acronym / sponsor ID
- 1831
- Conditions
- SARS-CoV-2
- Keywords
- Slums, Seroprevalence study, Participatory Research, Coronavirus, Community health, Clustering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Hospital de Niños R. Gutierrez de Buenos Aires, Salud Comunitaria Ministerio de Salud GCBA
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 15 Jul 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.
Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported.
Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test
Detailed description
A community-level seroprevalence survey was conducted in a cross-sectional design during a Participatory Action Research (PAR).
Starter PAR team: researcher who developed the Elisa Test, virologist that perform the analysis of the test and physician that served as volunteer field epidemiologist at the surveillance system (DetectAr Barrio 31) offered technical cooperation to test people experiencing homelessness.
PAR-First step: A sample for convenience of homeless people was tested during 3 days in a popular dining room managed by a non-governmental organization. Samples were collected by a DetectAr nurse and a volunteer epidemiologist.
PAR-Second step: feasibility was determined by the DetectAr coordinators of the Community Health Division of the Ministry of Health and the 12 health community workers (HCWs) when two volunteer epidemiologists from a University Institute explained the field organization (sample technique, data collection and database entry) for obtaining a probabilistic sample of residents. The PAR process was a cornerstone for reaching the sample size.
PAR-Third step: A cross-sectional study for seroprevalence survey was carried out.
Sample size and sample method Sample size was calculated for a seroprevalence of 5% according to evidence. A two-stage random sampling method was applied. First level: sector of the slum, Second level: geographical areas determined by the Department of Statistic and Census. Thirty houses were selected at this level. People over 14 years old were tested at the front door of their houses.
Serological test An enzyme linked immunosorbent assay [ELISA] developed in Argentina, by a laboratory in Buenos Aires, Argentina, was used. Performance characteristics are a high specificity (>95%) and a high sensibility (>95%) for SARS-COV-2 IgG. The test detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike. Viral proteins were expressed in human cells. This kit has obtained regulatory approval by Argentina's national drug regulatory agency (ANMAT, National Administration for Drugs, Food and Medical Devices)[. Blood samples were collected in a capillary tube from a finger prick, taken at the front door of each house. All HCWs were trained and epidemiological data was entered in a database. Samples were processed and analyzed at the virology laboratory in a pediatric hospital of Buenos Aires.
Statistical analysis To obtain the weighted prevalence, sample dataset was expanded to that of the last census by 3 factors: at neighborhood level, at household level and at individual level. The calculation of expansion factors at the household level is the inverse of the joint probability of selecting the last sampling unit (a household). The expansion factors at the household level imply three types of adjustments. The first one is related with non-response (given that some households did not want to answer the survey); the second one corresponds to the projection of sample to the entire population, and the third one to calibration techniques with a final adjustment by groups of age and gender, using external information from population census. Therefore, calibration variables were people 14 year-old or more, grouped by sex and by intervals of age: 14-30; 31-45; 46-59; 60 and more.
Prevalence of IgG antibodies were adjusted using sampling weights and post-stratification to allow for differences in non-response rates based on age group, sex, and census-tract income.
As household members share exposure to COVID-19, thus the outcome (prevalence of COVID-19 IgG) should show some correlation within the household. To test clustering effect, a random effects logistic regression model (multilevel model) was applied as it includes the variation between clusters explicitly in the likelihood and therefore takes account of intracluster correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Barrio Mugica, Buenos Aires city, Argentina, This Barrio isone of the most overcrowded slums with more than 50.000 inhabitants, and almost 1500 people experiencing homelessness
Key inclusion criteria (1 listed)
- All subjects of 14 years or more who accept to be test
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Serological Assay or IgG for SARS-CoV-2Serological Assay for detection of IgG for SARS-CoV-2 | Diagnostic test | – |
Primary outcome
to establish the seroprevalence of SARS-CoV-2
Time frame: up to 20 weeks
Prevalence of positive IgG for SARS-CoV-2
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 17 Dec 2020.
- Background: PubMed 32421144Sood N, Simon P, Ebner P, Eichner D, Reynolds J, Bendavid E, Bhattacharya J. Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Los Angeles County, California, on April 10-11, 2020. JAMA. 2020 Jun 16;323(23):2425-2427. doi: 10.1001/jama.2020.8279.
- Background: PubMed 32422438Pereira RJ, Nascimento GNLD, Gratao LHA, Pimenta RS. The risk of COVID-19 transmission in favelas and slums in Brazil. Public Health. 2020 Jun;183:42-43. doi: 10.1016/j.puhe.2020.04.042. Epub 2020 May 8. No abstract available.
- Background: PubMed 32333243Corburn J, Vlahov D, Mberu B, Riley L, Caiaffa WT, Rashid SF, Ko A, Patel S, Jukur S, Martinez-Herrera E, Jayasinghe S, Agarwal S, Nguendo-Yongsi B, Weru J, Ouma S, Edmundo K, Oni T, Ayad H. Slum Health: Arresting COVID-19 and Improving Well-Being in Urban Informal Settlements. J Urban Health. 2020 Jun;97(3):348-357. doi: 10.1007/s11524-020-00438-6.
- Background: PubMed 26766425Moen EL, Fricano-Kugler CJ, Luikart BW, O'Malley AJ. Analyzing Clustered Data: Why and How to Account for Multiple Observations Nested within a Study Participant? PLoS One. 2016 Jan 14;11(1):e0146721. doi: 10.1371/journal.pone.0146721. eCollection 2016.
- Background: PubMed 20702692Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci. 2010 Aug 11;30(32):10601-8. doi: 10.1523/JNEUROSCI.0362-10.2010.
- Background: PubMed 24671065Aarts E, Verhage M, Veenvliet JV, Dolan CV, van der Sluis S. A solution to dependency: using multilevel analysis to accommodate nested data. Nat Neurosci. 2014 Apr;17(4):491-6. doi: 10.1038/nn.3648. Epub 2014 Mar 26.
- Background: PubMed 32543763Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.
- Background: PubMed 32350047Theel ES, Slev P, Wheeler S, Couturier MR, Wong SJ, Kadkhoda K. The Role of Antibody Testing for SARS-CoV-2: Is There One? J Clin Microbiol. 2020 Jul 23;58(8):e00797-20. doi: 10.1128/JCM.00797-20. Print 2020 Jul 23.
- Background: PubMed 32488763Buckley RM. Targeting the World's Slums as Fat Tails in the Distribution of COVID-19 Cases. J Urban Health. 2020 Jun;97(3):358-364. doi: 10.1007/s11524-020-00450-w.
- Studies on the processes of social and urban integration in three Buenos Aires slumsLink provided by the sponsor.
- Participatory action research in health systemsLink provided by the sponsor.
- Systemic Facilitation of Collective Processes: Supporting Creativity and Participative Processes in Groups, Communities and NetworksLink provided by the sponsor.
- COVID-19 reagentsLink provided by the sponsor.
- Household and population census: villas 31 and 31 bis, City of Buenos Aires 2009Link provided by the sponsor.
- The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Alicia Mistchenko, MD PHD principal investigator
Hospital de Niños Ricardo Gutierrez
Vanina L Pagotto, MD MG study chair
Hospital Italiano de Buenos Aires
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 SARS-CoV-2, 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 17 Dec 2020. 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 establish the seroprevalence of SARS-CoV-2 (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 NCT04472078, which also lists 9 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 17 Dec 2020.