Clinical trial NCT04826718: SARS-CoV-2/COVID-19 Infection Among Health Care Workers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
BCG
Health Care Worker
COVID-19
Lead sponsor: Universidade de Cabo Verde
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal
name: National Institute of Public Health of Cape Verde, Praia, Cape Verde
name: Centro de Investigacao em Saude de Manhica
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Bandim Health Project, Bissau, Guinea-Bissau
First posted: 2021-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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).

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.

Detailed 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Total number of days absent from work due to COVID-19
timeFrame: From March 2020 to March 2022
measure: Unplanned Absenteeism
timeFrame: 6 months after inclusion
measure: Symptomatology after infection by SARS-CoV-2
timeFrame: 6 months after inclusion
measure: Presence or absence of anti-SARS-CoV-2 Acs
timeFrame: 6 months after inclusion
measure: Duration of anti-SARS-CoV-2 Acs
timeFrame: After infection
Secondary outcomes:
Other outcomes:
Locations:
city: Praia
country: Cape Verde
facility: Universidade de Cabo Verde
state: Santiago
Study officials:
affiliation: Universidade de Cabo Verde
name: Isabel I Araújo, PhD
role: PRINCIPAL_INVESTIGATOR
References: