Clinical trial NCT05268939: Performance Evaluation of the LumiraDx SARS-CoV-2 & FLU A/B and SARS-CoV-2 & RSV Tests for Aid in the Assessment of COVID-19
Official title: A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Influenza A
Influenza Type B
RSV Infection
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 668
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Performance Evaluation study
Primary purpose: DIAGNOSTIC

Brief summary: A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Detailed description: Approximately one-thousand (1000) subjects will be enrolled in this study. Patients presenting to their health care professionals, drive through testing sites or research centers and meet the inclusion/exclusion criteria will be enrolled in the study.

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

The potential subject will be asked to provide relevant medical history information (i.e., regarding their influenza/RSV and or COVID-19-like symptoms), which will be evaluated against all inclusion and exclusion criteria depending in their cohort. A subject's SARS-CoV-2 vaccination status will also be collected including the doses, dates of vaccination and brand.

Specimens will be obtained from each subject enrolled using standard collection methods.

The objectives of this study are to:

* Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B Test in detecting SARS-CoV-2 and/ or influenza A or B in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or influenza as compared with an FDA EUA authorized or 510(k) comparative method.
* Evaluate the performance of the LumiraDx SARS-CoV-2 \& RSV Test in detecting SARS-CoV-2 and/ or RSV in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or RSV as compared with an FDA EUA authorized or 510(k) comparative method.
* Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Test.

Eligibility criteria: Inclusion Criteria:

1. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.
2. The subject must present in one of the following two cohorts:

   Covid Cohort:

   Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell, congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be in the last twelve (12) days.

   or The subject must have presented with respiratory symptoms and a documented positive SARS-CoV-2 PCR or antigen test in the past forty-eight (48) hours.

   Influenza/RSV Cohort:

   The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects must report having a fever, but a quantitative reported measurement is not necessary for inclusion. In addition to the fever, the subject must have two (2) or more of the following signs and symptoms for eligibility: cough, shortness of breath, difficulty breathing, muscle pain, joint pain, headache, chills, repeated shaking with chills, congestion or runny nose, diarrhea, nausea, vomiting, sneezing, sore throat, wheezing, fatigue, weakness and/or malaise or anorexia. The onset of these symptoms will be recorded and will be in the last four (4) days. OR The subject must have presented with respiratory symptoms and a documented positive Flu or RSV test in the past forty-eight (48) hours.
3. Written informed consent must be obtained prior to study enrollment. A subject who is a legal adult must be willing to give written informed consent and must agree to comply with study procedures. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of consent must give written informed consent and agree to comply with study procedures. Active assent should be obtained from children of appropriate intellectual age (as defined by the IRB)

Exclusion Criteria:

1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
2. Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
3. Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
4. The subject is undergoing treatment currently or had undergone within the past fourteen (14) days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
5. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
6. The subject has previously participated in this research study (CS-1262-01).

Primary outcomes:
measure: Performance evaluation by health care professionals
timeFrame: 4 months
measure: Point of Care usability
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Encinitas
country: United States
facility: Diagnamics, Inc
state: California
city: Miami Gardens
country: United States
facility: Excellence Medical and Research
state: Florida
city: Miami
country: United States
facility: Marisela Gonzalez, MD, PA
state: Florida
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Covington
country: United States
facility: Benchmark Research
state: Louisiana
city: Las Vegas
country: United States
facility: Machuca Foundation
state: Nevada
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
Study officials:
affiliation: Diagnamics, Inc
name: Ramin Farsad
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark Research
name: Sherri Casey
role: PRINCIPAL_INVESTIGATOR
affiliation: Cullman Clinical Trials
name: Justin Wilson
role: PRINCIPAL_INVESTIGATOR
affiliation: Excellence Medical and Research
name: Miguel Perez
role: PRINCIPAL_INVESTIGATOR
affiliation: Koch Family Medicine
name: Mary Imig
role: PRINCIPAL_INVESTIGATOR
affiliation: Marisela Gonzalez, MD, PA
name: Marisela Gonzalez
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Solutions
name: Lawrence Gervasi
role: PRINCIPAL_INVESTIGATOR
affiliation: Machuca Foundation
name: Rogelio Machuca
role: PRINCIPAL_INVESTIGATOR
References: