COVID-19AVISANCT04355338
Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA)
An observational study of COVID-19, run by Butantan Institute at 11 sites in Brazil.
Trial summary
This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 3,520 participants
- Where
- 11 sitesBrazil
- Study dates
- 25 Oct 2020to 30 Oct 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample size will be equally distributed in ten different cities of Brazil. Then, each site will have same representation of each age group. Participants can be selected from other ongoing community-based studies conducted in the site and from community in general. Balance of participant according to sex is recommended to the sites in all age group.
Who may be able to join
- Any sex or age
- Providing informed consent
- Agreement with all study visits, procedure and contacts
Who cannot join
- Previous suspected or confirmed COVID-19
- Febrile illness in the latest 72 hours
- Olfactory or gustatory dysfunction in the last three months
- Healthcare worker in a service with routine attention to COVID-19 patients
- Any conditions that can might hurdle participant's compliance to the study in tha opinion of the study team
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30750-140
Universidade Federal de Roraima - UFRR
Boa Vista, Roraima, 69304-000
Universidade de Brasília
Brasília, Federal District, 71691-082
Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
Cuiabá, Mount, 78048-610
Universidade Federal do Ceará
Fortaleza, Ceará, 60430-160
Universidade Federal de Sergipe
Laranjeiras, Sergipe, 49170-000
Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, Rondônia, 78918-791
Instituto de Infectologia Evandro Chagas - Fiocruz
Rio de Janeiro, 21710-232
Faculdade de Medicina de São José do Rio Preto - FAMERP
São José do Rio Preto, São Paulo, 15090-000
Faculdade Santa Marcelina
São Paulo, São Paulo, 08270-140
Hospital Estadual de Serrana
Serrana, São Paulo, 14150-000
About this study
Official title: Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.
Read the detailed description
This is an observational longitudinal study to assess incidence of SARS-CoV-2 infection in Brazil. The study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. For the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of COVID-19 among infected, regardless severity, is 10%. For the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to COVID-19 according to estimates per age group reported by Verity R et al. https://doi.org/10.1016/S1473-3099(20)30243-7 After the consent procedure, all participants will have a short interview, a IgG/IgM SARS-CoV-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. These procedures will be repeated every four weeks until the end of the study. Individuals with symptoms compatible will be followed-up to confirm COVID-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. Levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2 infection, Asymptomatic Infections, Antibodies, Neutralizing, Immunity, Humoral
- Medical subject headings
- COVID-19, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 0-9 years | Participants aging 0-9 years | |
| 10-19 years | Participants aging 10-19 years | |
| 20-29 years | Participants aging 20-29 years | |
| 30-39 years | Participants aging 30-39 years | |
| 40-49 years | Participants aging 40-49 years | |
| 50-59 years | Participants aging 50-59 years | |
| 60-69 years | Participants aging 60-69 years | |
| 70-79 tears | Participants aging 70-79 years | |
| 80+ years | Participants aging 80 years or more |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SARS-CoV-2 infection
Number of cases with serological/virological diagnosis for SARS-Co-2 infection
Measured: 24 months
Incidence of COVID-19
Number of cases of symptomatic SARS-CoV-2 infection
Measured: 24 months
Secondary outcomes (3)
Incidence of hospitalization due to COVID-19
Number of cases of hospitalization due to symptomatic SARS-Co-2 infection
Measured: 24 years
Level of neutralizing antibodies
Level of neutralizing antibodies in participants with SARS-Co-2 infection
Measured: 24 months
Previous SARS-CoV-2 infection
Positive serology for SARS-Co-2 infection at baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start25 Oct 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 3,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fernanda Boulos, MD, PhD, Study director, Butantan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355338
- Sponsor's protocol ID
- COV-01-IB
- Acronym
- AVISA
- Status last verified
- Feb 2024
- First submitted
- 17 Apr 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
- ClinicalTrials.gov ID
- NCT04355338
- Acronym / sponsor ID
- AVISA / COV-01-IB
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2 infection, Asymptomatic Infections, Antibodies, Neutralizing, Immunity, Humoral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,520 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 21 Apr 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.
This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.
Detailed description
This is an observational longitudinal study to assess incidence of SARS-CoV-2 infection in Brazil. The study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. For the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of COVID-19 among infected, regardless severity, is 10%. For the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to COVID-19 according to estimates per age group reported by Verity R et al. https://doi.org/10.1016/S1473-3099(20)30243-7 After the consent procedure, all participants will have a short interview, a IgG/IgM SARS-CoV-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. These procedures will be repeated every four weeks until the end of the study. Individuals with symptoms compatible will be followed-up to confirm COVID-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. Levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 0-9 years | – | –Participants aging 0-9 years |
| 10-19 years | – | –Participants aging 10-19 years |
| 20-29 years | – | –Participants aging 20-29 years |
| 30-39 years | – | –Participants aging 30-39 years |
| 40-49 years | – | –Participants aging 40-49 years |
| 50-59 years | – | –Participants aging 50-59 years |
| 60-69 years | – | –Participants aging 60-69 years |
| 70-79 tears | – | –Participants aging 70-79 years |
| 80+ years | – | –Participants aging 80 years or more |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample size will be equally distributed in ten different cities of Brazil. Then, each site will have same representation of each age group. Participants can be selected from other ongoing community-based studies conducted in the site and from community in general. Balance of participant according to sex is recommended to the sites in all age group.
Key inclusion criteria (3 listed)
- Any sex or age
- Providing informed consent
- Agreement with all study visits, procedure and contacts
Key exclusion criteria (5 listed)
- Previous suspected or confirmed COVID-19
- Febrile illness in the latest 72 hours
- Olfactory or gustatory dysfunction in the last three months
- Healthcare worker in a service with routine attention to COVID-19 patients
- Any conditions that can might hurdle participant's compliance to the study in tha opinion of the study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of SARS-CoV-2 infection
Time frame: 24 months
Number of cases with serological/virological diagnosis for SARS-Co-2 infection
Incidence of COVID-19
Time frame: 24 months
Number of cases of symptomatic SARS-CoV-2 infection
3 secondary outcomes
Incidence of hospitalization due to COVID-19
Time frame: 24 years
Level of neutralizing antibodies
Time frame: 24 months
Previous SARS-CoV-2 infection
Time frame: 6 months
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 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for COVID-19
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
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Fernanda Boulos, MD, PhD study director
Butantan Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Butantan Institute at 11 sites 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 3 inclusion and 5 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Incidence of SARS-CoV-2 infection (time frame: 24 months). 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 6 Feb 2025.