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

Sponsor
Universidade de Cabo Verde (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04826718
Collaborator
University of Southern Denmark (Other), Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal (Other), National Institute of Public Health of Cape Verde, Praia, Cape Verde (Other), Centro de Investigacao em Saude de Manhica (Other), European and Developing Countries Clinical Trials Partnership (EDCTP) (Other), Bandim Health Project, Bissau, Guinea-Bissau (Other)
400
1
9
44.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionaire

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?

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
400 participants
Observational Model:
Other
Time Perspective:
Other
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
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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).
Other Names:
  • SARS-CoV-2 Serology (POC Test)
  • SARS-CoV-2 Serology (ELISA Test)
  • 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
    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).
    Other Names:
  • SARS-CoV-2 Serology (POC Test)
  • SARS-CoV-2 Serology (ELISA Test)
  • Outcome Measures

    Primary Outcome Measures

    1. Total number of days absent from work due to COVID-19 [From March 2020 to March 2022]

      Absenteeism due to COVID-19 related symptoms

    2. Unplanned Absenteeism [6 months after inclusion]

      Unplanned absenteeism following SARS-CoV-2 infection

    3. Symptomatology after infection by SARS-CoV-2 [6 months after inclusion]

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

    4. Presence or absence of anti-SARS-CoV-2 Acs [6 months after inclusion]

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

    5. Duration of anti-SARS-CoV-2 Acs [After infection]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade de Cabo Verde Praia Santiago Cape Verde 379C

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Isabel I Araújo, PhD, Universidade de Cabo Verde

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universidade de Cabo Verde
    ClinicalTrials.gov Identifier:
    NCT04826718
    Other Study ID Numbers:
    • RIA2020ER-3049
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 13, 2021