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
NCT ID: NCT05268939
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
668 participants
INTERVENTIONAL
2022-01-04
2023-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
NCT04808921
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
NCT05289037
This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR
NCT05491993
Systems Biological Analysis of Immune Responses to RSV Vaccine
NCT07185399
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
NCT06585241
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nasal Swab
Nasal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness
LumiraDx SARS-CoV-2 & Flu A/B test
Swab Samples for Diagnostic test
LumiraDx SARS-CoV-2 & RSV test
Swab Samples for Diagnostic test
Nasopharyngeal Swab
Nasopharyngeal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness
LumiraDx SARS-CoV-2 & Flu A/B test
Swab Samples for Diagnostic test
LumiraDx SARS-CoV-2 & RSV test
Swab Samples for Diagnostic test
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LumiraDx SARS-CoV-2 & Flu A/B test
Swab Samples for Diagnostic test
LumiraDx SARS-CoV-2 & RSV test
Swab Samples for Diagnostic test
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LumiraDx UK Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ramin Farsad
Role: PRINCIPAL_INVESTIGATOR
Diagnamics, Inc
Sherri Casey
Role: PRINCIPAL_INVESTIGATOR
Benchmark Research
Justin Wilson
Role: PRINCIPAL_INVESTIGATOR
Cullman Clinical Trials
Miguel Perez
Role: PRINCIPAL_INVESTIGATOR
Excellence Medical and Research
Mary Imig
Role: PRINCIPAL_INVESTIGATOR
Koch Family Medicine
Marisela Gonzalez
Role: PRINCIPAL_INVESTIGATOR
Marisela Gonzalez, MD, PA
Lawrence Gervasi
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Solutions
Rogelio Machuca
Role: PRINCIPAL_INVESTIGATOR
Machuca Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cullman Clinical Trials
Cullman, Alabama, United States
Diagnamics, Inc
Encinitas, California, United States
Marisela Gonzalez, MD, PA
Miami, Florida, United States
Excellence Medical and Research
Miami Gardens, Florida, United States
Koch Family Medicine
Morton, Illinois, United States
Benchmark Research
Covington, Louisiana, United States
Machuca Foundation
Las Vegas, Nevada, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-CLIN-PROT-00034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.