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

COVID-19 Clinical Trial

Official title:

Associated Factors in the Transmission and Dynamics of SARS-CoV-2 Infection Among Health Care Workers in Hospitals on the Islands of Santiago and São Vicente in Cabo Verde

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826718
• Other study ID #: RIA2020ER-3049
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2023
• Source: Universidade de Cabo Verde
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 31, 2023
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Cape Verde	Universidade de Cabo Verde	Praia	Santiago

Sponsors (7)

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

Country where clinical trial is conducted

Cape Verde, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of days absent from work due to COVID-19	Absenteeism due to COVID-19 related symptoms	From March 2020 to March 2022
Primary	Unplanned Absenteeism	Unplanned absenteeism following SARS-CoV-2 infection	6 months after inclusion
Primary	Symptomatology after infection by SARS-CoV-2	If have or not any symptomes after SARS-CoV-2 infection	6 months after inclusion
Primary	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
Primary	Duration of anti-SARS-CoV-2 Acs	Time of duration of anti-SARS-CoV-2 Anti-N and anti-S	After infection