Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04826718
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2021
Last Update Posted : July 13, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Universidade de Cabo Verde

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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 6 Months
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
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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)




Primary Outcome Measures :
  1. Total number of days absent from work due to COVID-19 [ Time Frame: From March 2020 to March 2022 ]
    Absenteeism due to COVID-19 related symptoms

  2. Unplanned Absenteeism [ Time Frame: 6 months after inclusion ]
    Unplanned absenteeism following SARS-CoV-2 infection

  3. Symptomatology after infection by SARS-CoV-2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After infection ]
    Time of duration of anti-SARS-CoV-2 Anti-N and anti-S


Biospecimen Retention:   Samples Without DNA
Blood.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826718


Locations
Layout table for location information
Cape Verde
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
Layout table for investigator information
Principal Investigator: Isabel I Araújo, PhD Universidade de Cabo Verde
Layout table for additonal information
Responsible Party: Universidade de Cabo Verde
ClinicalTrials.gov Identifier: NCT04826718    
Other Study ID Numbers: RIA2020ER-3049
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases