SARS-CoV-2/COVID-19 Infection Among Health Care Workers

NCT ID: NCT04826718

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The present study finds opportunities and justifications, taking into consideration that the nature of professional practice in health needs scientific evidence resulting from systematic and systemic studies to strengthen the basis for the decisions made to have an impact on various levels, from the patient to health management itself. In addition, Cabo Verdean authorities may benefit from new evidence obtained by this study. It intends, in a growing number of health professionals exposed or infected with SARS-CoV-2, in the different health structures of the country, to contribute to substantiate a better perception of the problem and the required solutions. Therefore, assessing the potential risk factors for SARS-CoV-2 infection among healthcare workers will be essential to characterize virus transmission, preventing future infections in them and providing the associated healthcare. Due to the advances and important changes described, questions arise that guide this research and allow us to identify the problem.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The problem is stated in the following starting questions:

What conditions and factors are associated with infection and non-infection by SARS-CoV-2 among health professionals working in the three hospitals on the islands of Santiago and São Vicente? Which are they (gender, age group, profession, type of contact, etc.)? Where do the infected HCW typically work (sector)? When and how did the infection occur? What is the prevalence of SARS-CoV-2 antibody in professionals with confirmed SARS-CoV-2 infection and in HCW that thought they were not infected by SARS-CoV-2? How long do anti-SARS-CoV-2 antibodies last? What is the impact of infection on unplanned absenteeism? Which symptoms and complaints (if any) persists after SARS-CoV-2 infection?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 BCG Health Care Worker COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

All Health Care Worker (HCW) from Hospital in Santiago and S. Vicente islands, Cabo Verde

No interventions assigned to this group

Control

HCW who report no SARS-CoV-2 infection in the period prior to the interview and/or suspected COVID-19 in the period prior to the interview

Questionaire

Intervention Type OTHER

A questionnaire will be administered to all participants to evaluate exposures related to infection at the baseline (enrollement) - Baseline questionnaire. A Follow-up questionnaire to all participants will be done after 3 and 6 months.

Capillary blood collection, for diagnosis of anti-SARS-CoV-2 Antibodies by rapid test, will be done at the first interview, for all participants (cases and controls).

Collection of peripheral venous blood, for analysis of the presence and duration of anti-SARS-CoV-2 Antibodies (N and S) will be done at the first interview, and after 6 months for all participants (cases and controls).

Cases

HCW who report positive SARS-CoV-2 infection confirmed by performing a positive PCR test and/or positive Rapid Antigen Test in the period prior to the interview

Questionaire

Intervention Type OTHER

A questionnaire will be administered to all participants to evaluate exposures related to infection at the baseline (enrollement) - Baseline questionnaire. A Follow-up questionnaire to all participants will be done after 3 and 6 months.

Capillary blood collection, for diagnosis of anti-SARS-CoV-2 Antibodies by rapid test, will be done at the first interview, for all participants (cases and controls).

Collection of peripheral venous blood, for analysis of the presence and duration of anti-SARS-CoV-2 Antibodies (N and S) will be done at the first interview, and after 6 months for all participants (cases and controls).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionaire

A questionnaire will be administered to all participants to evaluate exposures related to infection at the baseline (enrollement) - Baseline questionnaire. A Follow-up questionnaire to all participants will be done after 3 and 6 months.

Capillary blood collection, for diagnosis of anti-SARS-CoV-2 Antibodies by rapid test, will be done at the first interview, for all participants (cases and controls).

Collection of peripheral venous blood, for analysis of the presence and duration of anti-SARS-CoV-2 Antibodies (N and S) will be done at the first interview, and after 6 months for all participants (cases and controls).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SARS-CoV-2 Serology (POC Test) SARS-CoV-2 Serology (ELISA Test)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being a healthcare professional working in one of the hospitals where the study will take place
* Be aged ≥18 years;
* Cases: SARS-CoV-2 infection confirmed by PCR test and/or Rapid Antigen Test;
* Control: No evidence and/or record of past infection with SARS-CoV-2.

Exclusion Criteria

* Case: Confirmation of diagnosis test for SARS-CoV-2 without indication of specimen collection date.
* Control: Suspected SARS-CoV-2 infection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern Denmark

OTHER

Sponsor Role collaborator

Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal

UNKNOWN

Sponsor Role collaborator

National Institute of Public Health of Cape Verde, Praia, Cape Verde

UNKNOWN

Sponsor Role collaborator

Centro de Investigacao em Saude de Manhica

OTHER

Sponsor Role collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

Bandim Health Project, Bissau, Guinea-Bissau

UNKNOWN

Sponsor Role collaborator

Universidade de Cabo Verde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabel I Araújo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade de Cabo Verde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade de Cabo Verde

Praia, Santiago, Cabo Verde

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cabo Verde

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RIA2020ER-3049

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.