Seroepidemiological Study of SARS-CoV-2 (COVID-19) 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

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; COVID
• Intervention / Treatment: Diagnostic test: Serological test; Diagnostic test: Nasopharyngeal Swab; Diagnostic test: Oropharyngeal Swab

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 Type: Observational
• Enrollment (Actual): 18901

Contacts and Locations

• Study Contact: Name: Alexander R Precioso, MD, PhD; Phone Number: +55 11 3723-2121; Email: alexander.precioso@butantan.gov.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05503-900
    • Avenida Vital Brasil 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• All potential volunteers invited to participate in the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
CORAS; Refugees living in the city of São Paulo	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
Hemocenter; Blood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2
CPP - Butantan Penitentiary Progression Center; Participants of the CPP - Butantan Penitentiary Progression Center	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
CHSP - Penitentiary System Hospital Center; Participants of the CHSP - Penitentiary System Hospital Center	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
SABE (Health, Wellness and Aging); Participants of the SABE Project (Health, Wellness and Aging)	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
ILPI - Long-Term Care Institution for the Elderly; Residents of the Long-Term Care Institution for the Elderly of Botucatu	Diagnostic test: Serological test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2
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 test; IgM and IgG for SARS-CoV-2; Diagnostic test: Nasopharyngeal Swab; PCR for SARS-CoV-2; Diagnostic test: Oropharyngeal Swab; PCR for SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Study Chair: Alexander R Precioso, MD, PhD, Instituto Butantan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: COVID-19-Epi-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No