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

NCT04826718 | Completed DMC

• 1 other identifier: RIA2020ER-3049
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Total number of days absent from work due to COVID-19

  Absenteeism due to COVID-19 related symptoms

  From March 2020 to March 2022

• Unplanned Absenteeism

  Unplanned absenteeism following SARS-CoV-2 infection

  6 months after inclusion

• Symptomatology after infection by SARS-CoV-2

  If have or not any symptomes after SARS-CoV-2 infection

  6 months after inclusion

• Presence or absence of anti-SARS-CoV-2 Acs

  Presence or not of anti-SARS-CoV-2 Anti-N and anti-S

  6 months after inclusion

• Duration of anti-SARS-CoV-2 Acs

  Time of duration of anti-SARS-CoV-2 Anti-N and anti-S

  After infection

Study Arms (3)

Cohort

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

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

Other: Questionaire

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

Other: Questionaire

Interventions

Questionaire 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).

Also known as: SARS-CoV-2 Serology (POC Test), SARS-CoV-2 Serology (ELISA Test)

Cases; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of the study is composed of health professionals working in the Hospitals of the islands of Santiago and S. Vicente. In addition to measuring infection-related exposures, specific SARS-CoV-2 infection-related parameters will also be assessed, including presence and duration of anti-SARS-CoV-2 antibodies; absenteeism due to infection; and self-reported symptomatology due to SARS-CoV-2/ COVID-19 infection. All participants be followed up to measure unplanned, infection-related absenteeism, illness-related symptomatology at 3 of for a period of 6 months. At 6 months after enrollement, all participants will also be assessed, including screening of presence of anti-SARS-CoV-2 antibodies (anti-N and anti-S).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade de Cabo Verde: lead
• University of Southern Denmark: collaborator
• Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal: collaborator
• National Institute of Public Health of Cape Verde, Praia, Cape Verde: collaborator
• Centro de Investigacao em Saude de Manhica: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Bandim Health Project, Bissau, Guinea-Bissau: collaborator

Study Sites (1)

Universidade de Cabo Verde

Praia, Santiago, 379C, Cabo Verde

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Isabel I Araújo, PhD

  Universidade de Cabo Verde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 1, 2021
• Study Start: July 1, 2021
• Primary Completion: September 8, 2021
• Study Completion: January 31, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)