- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04826718
SARS-CoV-2/COVID-19 Infection Among Health Care Workers
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Santiago
-
Praia, Santiago, Cape Verde, 379C
- Universidade de Cabo Verde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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).
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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
|
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:
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From March 2020 to March 2022
|
Unplanned Absenteeism
Time Frame: 6 months after inclusion
|
Unplanned absenteeism following SARS-CoV-2 infection
|
6 months after inclusion
|
Symptomatology after infection by SARS-CoV-2
Time Frame: 6 months after inclusion
|
If have or not any symptomes after SARS-CoV-2 infection
|
6 months after inclusion
|
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
|
6 months after inclusion
|
Duration of anti-SARS-CoV-2 Acs
Time Frame: After infection
|
Time of duration of anti-SARS-CoV-2 Anti-N and anti-S
|
After infection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Isabel I Araújo, PhD, Universidade de Cabo Verde
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIA2020ER-3049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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