Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings

NCT05514886 | Completed

• 1 other identifier: EXPERT-CoV-2
• Study Type: observational
• Target: 3,429
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with SARS-CoV-2 infection

  The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection

  24 months

Interventions

Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test DEVICE

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.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection

You may qualify if:

• 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

You may not qualify if:

• Inability or unwillingness to give written informed consent/assent.

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead
• University of Kinshasa: collaborator
• Research Institute for Health Sciences - Burkina Faso: collaborator
• Universiteit Antwerpen, Belgium: collaborator
• Københavns Universitet: collaborator
• Universidad de Valencia, Spain: collaborator

Study Sites (1)

Nimr Korogwe

Tanga, Tanzania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal or nasal swabs

MeSH Terms

Conditions

COVID-19

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• DANIEL TR MINJA, PhD

  National Institute for Medical Research, Tanzania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: August 10, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TA (1)