SARS-CoV-2NCT04826718
SARS-CoV-2/COVID-19 Infection Among Health Care Workers
An observational study of SARS-CoV-2 and BCG, run by Universidade de Cabo Verde at 1 site in Cabo Verde.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, BCG, Health Care Worker
- What is being tested?
- Questionaire
- How many people
- 400 participants
- Where
- 1 siteCabo Verde
- Study dates
- 1 Jul 2021to 31 Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Case: Confirmation of diagnosis test for SARS-CoV-2 without indication of specimen collection date.
- Control: Suspected SARS-CoV-2 infection.
Trial locations and contacts
1 site in 1 country.
Cabo Verde1 site
Universidade de Cabo Verde
Praia, Santiago, 379C
About this study
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
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.
Read the 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?
- Conditions
- SARS-CoV-2, BCG, Health Care Worker, COVID-19
- Being tested
- Questionaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
Also called SARS-CoV-2 Serology (POC Test), SARS-CoV-2 Serology (ELISA Test)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionaire | |
| 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 Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of days absent from work due to COVID-19
Absenteeism due to COVID-19 related symptoms
Measured: From March 2020 to March 2022
Unplanned Absenteeism
Unplanned absenteeism following SARS-CoV-2 infection
Measured: 6 months after inclusion
Symptomatology after infection by SARS-CoV-2
If have or not any symptomes after SARS-CoV-2 infection
Measured: 6 months after inclusion
Presence or absence of anti-SARS-CoV-2 Acs
Presence or not of anti-SARS-CoV-2 Anti-N and anti-S
Measured: 6 months after inclusion
Duration of anti-SARS-CoV-2 Acs
Time of duration of anti-SARS-CoV-2 Anti-N and anti-S
Measured: After infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jul 2021
- Primary completion8 Sep 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidade de Cabo Verde
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Isabel I Araújo, PhD, Principal investigator, Universidade de Cabo Verde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826718
- Sponsor's protocol ID
- RIA2020ER-3049
- Status last verified
- Jun 2023
- First submitted
- 10 Mar 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04826718
- Acronym / sponsor ID
- RIA2020ER-3049
- Conditions
- SARS-CoV-2, BCG, Health Care Worker, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universidade de Cabo VerdeUniversity, hospital or other
- 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
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –All Health Care Worker (HCW) from Hospital in Santiago and S. Vicente islands, Cabo Verde |
| Control | – | Other: QuestionaireHCW 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 |
| Cases | – | Other: QuestionaireHCW 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Case: Confirmation of diagnosis test for SARS-CoV-2 without indication of specimen collection date.
- Control: Suspected SARS-CoV-2 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionaireAlso: SARS-CoV-2 Serology (POC Test), SARS-CoV-2 Serology (ELISA Test)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 | Cases, Control |
Primary outcome
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
Unplanned Absenteeism
Time frame: 6 months after inclusion
Unplanned absenteeism following SARS-CoV-2 infection
Symptomatology after infection by SARS-CoV-2
Time frame: 6 months after inclusion
If have or not any symptomes after SARS-CoV-2 infection
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
Duration of anti-SARS-CoV-2 Acs
Time frame: After infection
Time of duration of anti-SARS-CoV-2 Anti-N and anti-S
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel I Araújo, PhD principal investigator
Universidade de Cabo Verde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and BCG, run by Universidade de Cabo Verde at 1 site in Cabo Verde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cabo Verde. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of days absent from work due to COVID-19 (time frame: From March 2020 to March 2022). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.