Novel Rapid POC Diagnostics for COVID-19

NCT05438589 | Completed

• 1 other identifier: CV008
• Study Type: observational
• Target: 1,283
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective, multicentre study in which the diagnostic accuracy of multiple Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using prospectively collected nasal swabs and saliva samples from participants suspected to have Covid-19 infection (with or without symptoms). The study will last approximately 9 months.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using RT-PCR as reference standard

  at enrolment

Secondary Outcomes (1)

• Sensitivity and specificity in specific subgroups

  at enrolment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate. Each participant will have two respiratory swabs collected: one for RT-PCR testing and diagnosis, paired with a second swab to be used on the index Ag RDT. In order to meet the study objectives, two different population groups will be considered: 1. SYMPTOMATIC: Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with symptoms of COVID-19. 2. ASYMPTOMATIC: Individuals (≥ 18 years old) at risk of COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with no symptoms of COVID-19

You may qualify if:

• ≥18 years of age
• Presenting to testing locations linked to the clinical sites
• Suspected to have COVID-19 (as per WHO or national guidelines). These include the following groups:
• Individuals with acute onset of any of the following signs or symptoms: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status (for SYMPTOMATIC group);
• Contacts of confirmed cases of COVID-19
• Individuals residing or working in an area with high risk of transmission of virus
• Individuals residing or travelling to an area with community transmission
• Individuals working in any health care setting, including within health facilities or within the community
• Provided voluntary written consent to participate in this study
• Provided a specimen suitable for testing

You may not qualify if:

• Individuals unable to cooperate with respiratory sample collection
• Individuals on oxygen therapy
• Recent history of excessive nose bleeds
• Individuals unable to give informed consent
• Hemodynamic instability as determined by the treating physician

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (2)

National Center for Disease Control

Tbilisi, Georgia

Location

Ezintsha

Johannesburg, South Africa

Location

Study Officials

• Elena Ivanova Reipold, MD, PhD

  Find

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: June 30, 2022
• Study Start: April 25, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

GE (1); ZA (1)