LumiraDx SARS-CoV-2 & Flu A/B test for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
COVID19 (disease)+9 More
LumiraDx SARS-CoV-2 & Flu A/B test - DiagnosticTest
Eligibility
Any Age
All Sexes
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Study Summary

This trial is testing how well two different point-of-care tests work in detecting SARS-CoV-2, FLU A/B, and RSV in people with symptoms suggestive of these infections.

Eligible Conditions
  • COVID19 (disease)
  • Infections, Respiratory Syncytial Virus
  • COVID-19
  • Influenza Type B
  • influenza A virus

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 4 months

4 months
Performance evaluation by health care professionals
Point of Care usability

Trial Safety

Trial Design

2 Treatment Groups

Nasal Swab
1 of 2
Nasopharyngeal Swab
1 of 2
Experimental Treatment

1000 Total Participants · 2 Treatment Groups

Primary Treatment: LumiraDx SARS-CoV-2 & Flu A/B test · No Placebo Group · N/A

Nasal SwabExperimental Group · 2 Interventions: LumiraDx SARS-CoV-2 & RSV test, LumiraDx SARS-CoV-2 & Flu A/B test · Intervention Types: DiagnosticTest, DiagnosticTest
Nasopharyngeal SwabExperimental Group · 2 Interventions: LumiraDx SARS-CoV-2 & RSV test, LumiraDx SARS-CoV-2 & Flu A/B test · Intervention Types: DiagnosticTest, DiagnosticTest

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months

Who is running the clinical trial?

LumiraDx UK LimitedLead Sponsor
13 Previous Clinical Trials
30,701 Total Patients Enrolled
Justin WilsonPrincipal InvestigatorCullman Clinical Trials
Lawrence GervasiPrincipal InvestigatorClinical Research Solutions
Sherri CaseyPrincipal InvestigatorBenchmark Research
Miguel PerezPrincipal InvestigatorExcellence Medical and Research
Ramin FarsadPrincipal InvestigatorDiagnamics, Inc
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Marisela GonzalezPrincipal InvestigatorMarisela Gonzalez, MD, PA
Mary ImigPrincipal InvestigatorKoch Family Medicine
Rogelio MachucaPrincipal InvestigatorMachuca Foundation

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.