COVIDNCT04408014
Seroepidemiological Study of SARS-CoV-2 (COVID-19) Infection in Population Subgroups in the State of São Paulo
An observational study of COVID and SARS-CoV 2, run by Butantan Institute at 1 site in Brazil.
Trial summary
Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo Read more about this study
- Who is it for?
- Ages 6 months to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID, SARS-CoV 2
- What is being tested?
- Serological test, Nasopharyngeal Swab and Oropharyngeal Swab
- How many people
- 18,901 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2020to 30 Jul 2020
- 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 6 months to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Home contacts of health professionals at the Hospital das Clínicas of the Medical School of USP diagnosed with COVID-19; * Refugees living in the city of São Paulo - CORAS-BR Project; * Blood Donors of the Fundação Pró-Sangue Hemocentro de São Paulo * Butantan Penitentiary Progression Center participants; * Penitentiary System Hospital Center (CHSP) participants; * SABE Project - Cohort of the Elderly in the city of São Paulo and their home contacts; * Residents of the Long Term Care Institution (ILPI) of Botucatu; * Home contacts of children and adolescents with a positive diagnosis for COVID-19, attended at Instituto da Criança, HCFMUSP.
Who may be able to join
- All potential volunteers invited to participate in the study.
Who cannot join
- All potential eligible participants, but who do not show interest in participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
Read the detailed description
This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2 is different population subgroups in the State of São Paulo
- Conditions
- COVID, SARS-CoV 2
- Being tested
- Serological test, Nasopharyngeal Swab, Oropharyngeal Swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological testDiagnostic test
IgM and IgG for SARS-CoV-2
Nasopharyngeal SwabDiagnostic test
PCR for SARS-CoV-2
Oropharyngeal SwabDiagnostic test
PCR for SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| HC-USP | Home contacts of health professionals diagnosed with COVID-19 at the Hospital of Clínic of Medicine School of the University of São Paulo Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| CORAS | Refugees living in the city of São Paulo Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| Hemocenter | Blood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo Receives: Diagnostic Test: Serological test | |
| CPP - Butantan Penitentiary Progression Center | Participants of the CPP - Butantan Penitentiary Progression Center Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| CHSP - Penitentiary System Hospital Center | Participants of the CHSP - Penitentiary System Hospital Center Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| SABE (Health, Wellness and Aging) | Participants of the SABE Project (Health, Wellness and Aging) Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| ILPI - Long-Term Care Institution for the Elderly | Residents of the Long-Term Care Institution for the Elderly of Botucatu Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab | |
| ICR-USP - Children's Institute of HCFMUSP | Home contacts of children and adolescents diagnosed with COVID-19, attended at the Children's Institute of HCFMUSP Receives: Diagnostic Test: Serological test; Diagnostic Test: Nasopharyngeal Swab; Diagnostic Test: Oropharyngeal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antibodies against SARS-CoV-2 through serological testing
IgM and IgG antibodies against SARS-CoV-2
Measured: 1 month
Frequency of participants with a positive RT-PCR test result for SARS-CoV-2
Positive RT-PCR test result for SARS-CoV-2
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion15 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 18,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexander R Precioso, MD, PhD, Study chair, Instituto butantan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408014
- Sponsor's protocol ID
- COVID-19-Epi-01
- Status last verified
- Feb 2024
- First submitted
- 22 May 2020
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
- ClinicalTrials.gov ID
- NCT04408014
- Acronym / sponsor ID
- COVID-19-Epi-01
- Conditions
- COVID, SARS-CoV 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,901 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 29 May 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.
Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
Detailed description
This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2 is different population subgroups in the State of São Paulo
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HC-USP | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabHome contacts of health professionals diagnosed with COVID-19 at the Hospital of Clínic of Medicine School of the University of São Paulo |
| CORAS | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabRefugees living in the city of São Paulo |
| Hemocenter | – | Diagnostic Test: Serological testBlood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo |
| CPP - Butantan Penitentiary Progression Center | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabParticipants of the CPP - Butantan Penitentiary Progression Center |
| CHSP - Penitentiary System Hospital Center | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabParticipants of the CHSP - Penitentiary System Hospital Center |
| SABE (Health, Wellness and Aging) | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabParticipants of the SABE Project (Health, Wellness and Aging) |
| ILPI - Long-Term Care Institution for the Elderly | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabResidents of the Long-Term Care Institution for the Elderly of Botucatu |
| ICR-USP - Children's Institute of HCFMUSP | – | Diagnostic Test: Serological test, Diagnostic Test: Nasopharyngeal Swab, Diagnostic Test: Oropharyngeal SwabHome contacts of children and adolescents diagnosed with COVID-19, attended at the Children's Institute of HCFMUSP |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Home contacts of health professionals at the Hospital das Clínicas of the Medical School of USP diagnosed with COVID-19; * Refugees living in the city of São Paulo - CORAS-BR Project; * Blood Donors of the Fundação Pró-Sangue Hemocentro de São Paulo * Butantan Penitentiary Progression Center participants; * Penitentiary System Hospital Center (CHSP) participants; * SABE Project - Cohort of the Elderly in the city of São Paulo and their home contacts; * Residents of the Long Term Care Institution (ILPI) of Botucatu; * Home contacts of children and adolescents with a positive diagnosis for COVID-19, attended at Instituto da Criança, HCFMUSP.
Key inclusion criteria (1 listed)
- All potential volunteers invited to participate in the study.
Key exclusion criteria (1 listed)
- All potential eligible participants, but who do not show interest in participating in the study.
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 testIgM and IgG for SARS-CoV-2 | Diagnostic test | CHSP - Penitentiary System Hospital Center, CORAS, CPP - Butantan Penitentiary Progression Center, HC-USP, Hemocenter, ICR-USP - Children's Institute of HCFMUSP, ILPI - Long-Term Care Institution for the Elderly, SABE (Health, Wellness and Aging) |
| Nasopharyngeal SwabPCR for SARS-CoV-2 | Diagnostic test | CHSP - Penitentiary System Hospital Center, CORAS, CPP - Butantan Penitentiary Progression Center, HC-USP, ICR-USP - Children's Institute of HCFMUSP, ILPI - Long-Term Care Institution for the Elderly, SABE (Health, Wellness and Aging) |
| Oropharyngeal SwabPCR for SARS-CoV-2 | Diagnostic test | CHSP - Penitentiary System Hospital Center, CORAS, CPP - Butantan Penitentiary Progression Center, HC-USP, ICR-USP - Children's Institute of HCFMUSP, ILPI - Long-Term Care Institution for the Elderly, SABE (Health, Wellness and Aging) |
Primary outcome
Prevalence of antibodies against SARS-CoV-2 through serological testing
Time frame: 1 month
IgM and IgG antibodies against SARS-CoV-2
Frequency of participants with a positive RT-PCR test result for SARS-CoV-2
Time frame: 1 month
Positive RT-PCR test result 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 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Alexander R Precioso, MD, PhD study chair
Instituto butantan
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 COVID and SARS-CoV 2, run by Butantan Institute at 1 site in Brazil.
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 15 Feb 2024. 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 Brazil. 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?
Prevalence of antibodies against SARS-CoV-2 through serological testing (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.