NCT04408014

Brief Summary

Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

May 22, 2020

Last Update Submit

February 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of antibodies against SARS-CoV-2 through serological testing

    IgM and IgG antibodies against SARS-CoV-2

    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

    1 month

Study Arms (8)

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

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

CORAS

Refugees living in the city of São Paulo

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

Hemocenter

Blood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo

Diagnostic Test: Serological test

CPP - Butantan Penitentiary Progression Center

Participants of the CPP - Butantan Penitentiary Progression Center

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

CHSP - Penitentiary System Hospital Center

Participants of the CHSP - Penitentiary System Hospital Center

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

SABE (Health, Wellness and Aging)

Participants of the SABE Project (Health, Wellness and Aging)

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

ILPI - Long-Term Care Institution for the Elderly

Residents of the Long-Term Care Institution for the Elderly of Botucatu

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic 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

Diagnostic Test: Serological testDiagnostic Test: Nasopharyngeal SwabDiagnostic Test: Oropharyngeal Swab

Interventions

Serological testDIAGNOSTIC_TEST

IgM and IgG for SARS-CoV-2

CHSP - Penitentiary System Hospital CenterCORASCPP - Butantan Penitentiary Progression CenterHC-USPHemocenterICR-USP - Children's Institute of HCFMUSPILPI - Long-Term Care Institution for the ElderlySABE (Health, Wellness and Aging)
Nasopharyngeal SwabDIAGNOSTIC_TEST

PCR for SARS-CoV-2

CHSP - Penitentiary System Hospital CenterCORASCPP - Butantan Penitentiary Progression CenterHC-USPICR-USP - Children's Institute of HCFMUSPILPI - Long-Term Care Institution for the ElderlySABE (Health, Wellness and Aging)
Oropharyngeal SwabDIAGNOSTIC_TEST

PCR for SARS-CoV-2

CHSP - Penitentiary System Hospital CenterCORASCPP - Butantan Penitentiary Progression CenterHC-USPICR-USP - Children's Institute of HCFMUSPILPI - Long-Term Care Institution for the ElderlySABE (Health, Wellness and Aging)

Eligibility Criteria

Age6 Months - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • All potential volunteers invited to participate in the study.

You may not qualify if:

  • All potential eligible participants, but who do not show interest in participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avenida Vital Brasil 1500

São Paulo, 05503-900, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal Swab, Oropharyngeal Swab and Blood Samples

MeSH Terms

Interventions

Serologic Tests

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Alexander R Precioso, MD, PhD

    Instituto butantan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 29, 2020

Study Start

June 1, 2020

Primary Completion

July 15, 2020

Study Completion

July 30, 2020

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations