SARS-CoV InfectionPRESTACOVNCT04699058
COVID-19 Sero-prevalence Health Care Workers Kinshasa
An observational study of SARS-CoV Infection and Seroprevalence, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial summary
This is a cohort study, in which the investigators will follow-up 650 health care workers (HCW) and a selection of their households (of COVID positive and COVID negative HCW) at baseline and in three follow-up surveys, with 4 to 6 weeks of time interval. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Seroprevalence
- What is being tested?
- COVID-antibody test
- How many people
- 1,200 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 17 Jul 2020to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health care workers: All staff working in health care facilities of the selected health zones of Kinshasa: Lingwala, Bandalungwa, Limete, Ndjili and Lemba. Household members: All household members of participating Health care workers. Household members can be defined as the members of a household, which consists of a person or group of persons who live together in the same house, share the same housekeeping arrangements and usually eat meals together.
Who may be able to join
- For Both groups:
- Willing to provide written informed consent
- Being sick or having had COVID-19 is not an exclusion criterion
- Health care workers
- Health care worker (all categories from specialist doctors to allied and auxiliary health workers) of the selected health services
- foreseen to be employed (or place of internship) for the next three months in he selected health facility
Show all 9Show fewer
- Household members
- Willing not to change the residence during the study period
- Household member of included Health care workers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Institut Nationale de recherche Biomédicale
Kinshasa
About this study
Official title: Sero-prevalence and Sero-conversion Study of Health Care Workers and Their Households, Democratic Republic of the Congo
This is a cohort study, in which the investigators will follow-up 650 health care workers (HCW) and a selection of their households (of COVID positive and COVID negative HCW) at baseline and in three follow-up surveys, with 4 to 6 weeks of time interval. The investigators will select HCW from different wards and different health care structures in 5 communes of Kinshasa. Additionally, in the first survey among HCW, the investigators will test with different diagnostic platform to evaluate the performance of serological tests in the African setting and the effect of malaria infection on the performance of tests.
An amendment is added to the protocol, stating an additional 2 surveys in april/June 2021 and October/November 2021 to evaluate impact of second wave and of vaccination campaign.
Read the detailed description
Rationale:
There is no information on how intense transmission of COVID-19 happens in Kinshasa, partly due to a reduced laboratory capacity for polymerase chain reaction (PCR) confirmation of acute cases, and an aspecific presentation of clinical symptoms. The focus of this COVID-19 seroprevalence study on health care workers and their households, was based on the following rationale. Health care workers (HCW) are among the groups at higher risk as they are directly or indirectly exposed to COVID-19 patients. They also form a group of specific interest as they are in close contact to vulnerable patients at high risk for severe COVID-19. In addition, their illness or absence from work significantly affects the health system's ability to respond to the COVID-19 pandemic and retain its other essential functions. HCW are trained in infection prevention and control (IPC). However, it is likely that at least some of them will get infected either at their workplace(s) or elsewhere. In particular health facilities with limited access to personal protective equipment (PPE) and regular water and sanitation facilities, IPC could even potentially be hampered, resulting in an increased risk of infection transmission among HCW, from HCW to their patients as well as to their household members. Because of this crucial role played by HCW in the transmission chain, it is of utmost importance to assess the proportion of asymptomatic infections among them.
Aim of the study:
This study aims to investigate severe acute respiratory syndrome (SARS-CoV-2) seroprevalence and seroconversion among HCW in Democratic Republic of Congo (DRC) and their household members, including asymptomatic ones, in order to generate insights into the transmission dynamics as well as the clinical presentation of the disease.
Primary objectives
- Determine seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa at T0;
- Determine seroprevalence of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa at T0;
- Determine incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 3 months' time period;
- Determine SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a three months' time period.
Secondary objectives
- Identify work-related risk factors (infrastructural, availability of equipment and behavioral) for seroconversion of HCW;
- Identify socio-demographic and behavioral risk factors for seroconversion of household members;
- Determine the proportion of asymptomatic cases among seroconversions occurred during the study period among HCW as well as among their household members;
- Assess secondary attack rate among household members of symptomatic and asymptomatic HCW.
- To compare the performance of an in-house Luminex platform serologic diagnostic test, commercialized antibody ELISA test and an antibody rapid diagnostic test (RDT) against the gold standard serological test (neutralization) in tropical settings with intense cocirculation of malaria and other infectious diseases
Description: 650 HCW and 1000 household members will be surveyed at 4 time moments. At each moment, a questionnaire is filled exploring the professional and community risk exposure and the appearance of symptoms compatible with a COVID infection. At the same time, a serum sample is taken by the HCW and a 'dried blood spot' is done by the household members. These samples will be analyzed to verify if the participants were exposed to the SARS-CoV2 since the start of the epidemic. The use of a cohort will allow us to describe how the epidemic evolves over a 4 to 6 month period in Kinshasa, but will also make it possible to evaluate how the antibodies are waning or not waning over time.
An amendment is added to the protocol, stating an additional 2 surveys in april/June 2021 and October/November 2021 to evaluate impact of second wave and of vaccination campaign.
- Conditions
- SARS-CoV Infection, Seroprevalence
- Being tested
- COVID-antibody test
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-antibody testDiagnostic test
Questionnaire and COVID-antibody test for all participants
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | questionnaire and COVID antibody test Receives: Diagnostic Test: COVID-antibody test | |
| Household members | questionnaire and COVID antibody test Receives: Diagnostic Test: COVID-antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID antibody prevalence in Health care workers (serological test)
Antibody detection through ELISA and Luminex multiplex platform to estimate seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa
Measured: Month 2
COVID antibody prevalence in Household members (serological test)
Antibody detection through Luminex multiplex platform to estimate of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa
Measured: Month 2
Seroconversion COVID Health care workers (serological test)
Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 5 months' time period
Measured: Month 6
Seroconversion COVID household members (serological test)
Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a five months' time period
Measured: Month 6
Secondary outcomes (2)
work-related exposure evaluated through a questionnaire and summarized as a score
the higher the score, the more exposed to the work-related risk factors (infrastructural, availability of equipment and behavioral); the higher the association is of a seroconversion with a higher score, the higher is the work-related exposure a risk factor for seroconversion.
Measured: Month 6
behavioural risk factors (questionnaire), summarized as a score
the higher the score, the more exposed to risk behaviours (mobility, household); the higher the association is of a seroconversion with a higher score, the higher is the behaviour-related exposure a risk factor for seroconversion.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start17 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Principal investigator, Veerle Vanlerberghe, Institute of Tropical Medicine, Belgium
- Investigators
- Veerle Vanlerberghe, PhD, Principal investigator, ITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699058
- Sponsor's protocol ID
- B3002020000144
- Acronym
- PRESTACOV
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2020
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: COVID-19 related information (sero-prevalence, individual status of infection, etc.) will not be made available openly to avoid stigmatisation, they will be made available upon request using a data sharing agreement to assure confidentiality for the individuals.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-prevalence and Sero-conversion Study of Health Care Workers and Their Households, Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT04699058
- Acronym / sponsor ID
- PRESTACOV / B3002020000144
- Conditions
- SARS-CoV Infection, Seroprevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jan 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.
This is a cohort study, in which the investigators will follow-up 650 health care workers (HCW) and a selection of their households (of COVID positive and COVID negative HCW) at baseline and in three follow-up surveys, with 4 to 6 weeks of time interval. The investigators will select HCW from different wards and different health care structures in 5 communes of Kinshasa. Additionally, in the first survey among HCW, the investigators will test with different diagnostic platform to evaluate the performance of serological tests in the African setting and the effect of malaria infection on the performance of tests.
An amendment is added to the protocol, stating an additional 2 surveys in april/June 2021 and October/November 2021 to evaluate impact of second wave and of vaccination campaign.
Detailed description
Rationale:
There is no information on how intense transmission of COVID-19 happens in Kinshasa, partly due to a reduced laboratory capacity for polymerase chain reaction (PCR) confirmation of acute cases, and an aspecific presentation of clinical symptoms. The focus of this COVID-19 seroprevalence study on health care workers and their households, was based on the following rationale. Health care workers (HCW) are among the groups at higher risk as they are directly or indirectly exposed to COVID-19 patients. They also form a group of specific interest as they are in close contact to vulnerable patients at high risk for severe COVID-19. In addition, their illness or absence from work significantly affects the health system's ability to respond to the COVID-19 pandemic and retain its other essential functions. HCW are trained in infection prevention and control (IPC). However, it is likely that at least some of them will get infected either at their workplace(s) or elsewhere. In particular health facilities with limited access to personal protective equipment (PPE) and regular water and sanitation facilities, IPC could even potentially be hampered, resulting in an increased risk of infection transmission among HCW, from HCW to their patients as well as to their household members. Because of this crucial role played by HCW in the transmission chain, it is of utmost importance to assess the proportion of asymptomatic infections among them.
Aim of the study:
This study aims to investigate severe acute respiratory syndrome (SARS-CoV-2) seroprevalence and seroconversion among HCW in Democratic Republic of Congo (DRC) and their household members, including asymptomatic ones, in order to generate insights into the transmission dynamics as well as the clinical presentation of the disease.
Primary objectives
- Determine seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa at T0;
- Determine seroprevalence of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa at T0;
- Determine incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 3 months' time period;
- Determine SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a three months' time period.
Secondary objectives
- Identify work-related risk factors (infrastructural, availability of equipment and behavioral) for seroconversion of HCW;
- Identify socio-demographic and behavioral risk factors for seroconversion of household members;
- Determine the proportion of asymptomatic cases among seroconversions occurred during the study period among HCW as well as among their household members;
- Assess secondary attack rate among household members of symptomatic and asymptomatic HCW.
- To compare the performance of an in-house Luminex platform serologic diagnostic test, commercialized antibody ELISA test and an antibody rapid diagnostic test (RDT) against the gold standard serological test (neutralization) in tropical settings with intense cocirculation of malaria and other infectious diseases
Description: 650 HCW and 1000 household members will be surveyed at 4 time moments. At each moment, a questionnaire is filled exploring the professional and community risk exposure and the appearance of symptoms compatible with a COVID infection. At the same time, a serum sample is taken by the HCW and a 'dried blood spot' is done by the household members. These samples will be analyzed to verify if the participants were exposed to the SARS-CoV2 since the start of the epidemic. The use of a cohort will allow us to describe how the epidemic evolves over a 4 to 6 month period in Kinshasa, but will also make it possible to evaluate how the antibodies are waning or not waning over time.
An amendment is added to the protocol, stating an additional 2 surveys in april/June 2021 and October/November 2021 to evaluate impact of second wave and of vaccination campaign.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Diagnostic Test: COVID-antibody testquestionnaire and COVID antibody test |
| Household members | – | Diagnostic Test: COVID-antibody testquestionnaire and COVID antibody test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care workers: All staff working in health care facilities of the selected health zones of Kinshasa: Lingwala, Bandalungwa, Limete, Ndjili and Lemba. Household members: All household members of participating Health care workers. Household members can be defined as the members of a household, which consists of a person or group of persons who live together in the same house, share the same housekeeping arrangements and usually eat meals together.
Key inclusion criteria (9 listed)
- Willing to provide written informed consent
- Being sick or having had COVID-19 is not an exclusion criterion
- Health care workers
- Health care worker (all categories from specialist doctors to allied and auxiliary health workers) of the selected health services
- foreseen to be employed (or place of internship) for the next three months in he selected health facility
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COVID-antibody testQuestionnaire and COVID-antibody test for all participants | Diagnostic test | Health care workers, Household members |
Primary outcome
COVID antibody prevalence in Health care workers (serological test)
Time frame: Month 2
Antibody detection through ELISA and Luminex multiplex platform to estimate seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa
COVID antibody prevalence in Household members (serological test)
Time frame: Month 2
Antibody detection through Luminex multiplex platform to estimate of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa
Seroconversion COVID Health care workers (serological test)
Time frame: Month 6
Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 5 months' time period
Seroconversion COVID household members (serological test)
Time frame: Month 6
Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a five months' time period
2 secondary outcomes
work-related exposure evaluated through a questionnaire and summarized as a score
Time frame: Month 6
behavioural risk factors (questionnaire), summarized as a score
Time frame: Month 6
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 2 Dec 2022.
- Individual participant dataSharing planned: No. COVID-19 related information (sero-prevalence, individual status of infection, etc.) will not be made available openly to avoid stigmatisation, they will be made available upon request using a data sharing agreement to assure confidentiality for the individuals.
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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.
Veerle Vanlerberghe, PhD principal investigator
ITG
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 Infection and Seroprevalence, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
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 9 inclusion and 0 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 2 Dec 2022. 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 Democratic Republic of the Congo. 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?
COVID antibody prevalence in Health care workers (serological test) (time frame: Month 2). The study lists 4 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 2 Dec 2022.