COVID-19EXPERT-CoV-2NCT05514886
Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings
An observational study of COVID-19, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
This study evaluated the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test
- Type of treatment
- Medical device
- How many people
- 3,429 participants
- Where
- 1 siteTanzania
- Study dates
- 10 Aug 2022to 29 Feb 2024
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection
Who may be able to join
- Aged 5 years and above presenting with symptoms as indicated in national COVID-19 standard cases definitions or
- Presence of one or more respiratory symptoms (fever (defined as >37.5°C), Persistent coughs, headache, myalgia, sore throat ) or One risk factor for COVID-19, including known contact with a patient with COVID-19, underlying comorbidities, smoking.
- Provision of an informed consent/assent (for minors aged 11-17 years) by themselves or parents/guardians to participate
Who cannot join
- Inability or unwillingness to give written informed consent/assent.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Read the detailed description
Project Title: Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (RIA2020EF-2990) - EXPERT-CoV-2
Clinical Trial Registration: NCT05514886
Principal Investigator: Dr Daniel T. R Minja, NIMR- Tanga Centre, Korogwe Research Station, Tanzania
Collaborating Partners: University of Kinshasa, DR Congo, Research Institute for Health Sciences, Burkina Faso, University of Copenhagen, Denmark, University of Antwerp, Belgium, University of Valencia, Spain
Funding: This project (RIA2020EF-2990) is part of the EDCTP2 programme supported by the European Union.
Date: 17th July 2024
Background: Rapid diagnostic tests of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implementing early case detection and management to control the spread of the deadly virus. RT-PCR is the gold standard for the detection of SARS-CoV-2 but its availability and usability is impeded by fragmented laboratory infrastructure in LMICs and even when available it's only found in reference labs.
The recent development of the Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test, Cepheid Sunnyvale, CA) for SARS-CoV-2 testing in the clinics with results delivery within hours of sample collection has been vital in resolving the turnaround time (TAT). GeneXpert has been widely rolled out within national tuberculosis (TB) and HIV programmes across Africa. However, evaluation of its diagnostic accuracy and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.
Study objective: This study is envisaged to evaluate the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Methods and Results: This study was conducted in Tanzania, Burkina Faso and DR Congo between 21st July 2021 and February 2024. Data analyses are ongoing and further updates will be made available once the final phylogenetic analyses are completed and ready for publication, details of the clades and variants will also be available.
- Conditions
- COVID-19
- Being tested
- Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV testDevice
POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralized healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with SARS-CoV-2 infection
The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start10 Aug 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,429 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- University of Kinshasa, Research Institute for Health Sciences - Burkina Faso, Universiteit Antwerpen, Belgium, Københavns Universitet, Universidad de Valencia, Spain
- Responsible party
- Principal investigator, Daniel T Minja, PhD, National Institute for Medical Research, Tanzania
- Investigators
- DANIEL TR MINJA, PhD, Principal investigator, National Institute for Medical Research, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514886
- Sponsor's protocol ID
- EXPERT-CoV-2
- Acronym
- EXPERT-CoV-2
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be discussed in the consortium and once consensus has been reached, it will be decided on which information and data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings
- ClinicalTrials.gov ID
- NCT05514886
- Acronym / sponsor ID
- EXPERT-CoV-2 / EXPERT-CoV-2
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,429 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- University of Kinshasa, Research Institute for Health Sciences - Burkina Faso, Universiteit Antwerpen, Belgium, Københavns Universitet, Universidad de Valencia, Spain
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 25 Aug 2022 (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 study evaluated the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Detailed description
Project Title: Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (RIA2020EF-2990) - EXPERT-CoV-2
Clinical Trial Registration: NCT05514886
Principal Investigator: Dr Daniel T. R Minja, NIMR- Tanga Centre, Korogwe Research Station, Tanzania
Collaborating Partners: University of Kinshasa, DR Congo, Research Institute for Health Sciences, Burkina Faso, University of Copenhagen, Denmark, University of Antwerp, Belgium, University of Valencia, Spain
Funding: This project (RIA2020EF-2990) is part of the EDCTP2 programme supported by the European Union.
Date: 17th July 2024
Background: Rapid diagnostic tests of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implementing early case detection and management to control the spread of the deadly virus. RT-PCR is the gold standard for the detection of SARS-CoV-2 but its availability and usability is impeded by fragmented laboratory infrastructure in LMICs and even when available it's only found in reference labs.
The recent development of the Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test, Cepheid Sunnyvale, CA) for SARS-CoV-2 testing in the clinics with results delivery within hours of sample collection has been vital in resolving the turnaround time (TAT). GeneXpert has been widely rolled out within national tuberculosis (TB) and HIV programmes across Africa. However, evaluation of its diagnostic accuracy and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.
Study objective: This study is envisaged to evaluate the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Methods and Results: This study was conducted in Tanzania, Burkina Faso and DR Congo between 21st July 2021 and February 2024. Data analyses are ongoing and further updates will be made available once the final phylogenetic analyses are completed and ready for publication, details of the clades and variants will also be available.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection
Key inclusion criteria (3 listed)
- Aged 5 years and above presenting with symptoms as indicated in national COVID-19 standard cases definitions or
- Presence of one or more respiratory symptoms (fever (defined as >37.5°C), Persistent coughs, headache, myalgia, sore throat ) or One risk factor for COVID-19, including known contact with a patient with COVID-19, underlying comorbidities, smoking.
- Provision of an informed consent/assent (for minors aged 11-17 years) by themselves or parents/guardians to participate
Key exclusion criteria (1 listed)
- Inability or unwillingness to give written informed consent/assent.
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 |
|---|---|---|
| Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV testPOC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralized healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso. | Device | – |
Primary outcome
Proportion of patients with SARS-CoV-2 infection
Time frame: 24 months
The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided. This will be discussed in the consortium and once consensus has been reached, it will be decided on which information and data will be shared.
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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.
DANIEL TR MINJA, PhD principal investigator
National Institute for Medical Research, Tanzania
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 COVID-19, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
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 3 inclusion and 1 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 19 Sep 2024. 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 Tanzania. 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?
Proportion of patients with SARS-CoV-2 infection (time frame: 24 months). 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 19 Sep 2024.