CLINICAL TRIAL

LumiraDx SARS-CoV-2 & RSV test for Influenza Type B

Recruiting · Any Age · All Sexes · Morton, IL

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

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About the trial for Influenza Type B

Eligible Conditions
Influenza Type B · Influenza, Human · Respiratory Syncytial Virus Infections · COVID-19 · Influenza A Virus Infection · Infections, Respiratory Syncytial Virus

Treatment Groups

This trial involves 2 different treatments. LumiraDx SARS-CoV-2 & RSV Test is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
LumiraDx SARS-CoV-2 & RSV test
DIAGNOSTICTEST
+
LumiraDx SARS-CoV-2 & Flu A/B test
DIAGNOSTICTEST
Experimental Group 2
LumiraDx SARS-CoV-2 & RSV test
DIAGNOSTICTEST
+
LumiraDx SARS-CoV-2 & Flu A/B test
DIAGNOSTICTEST

Eligibility

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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.
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.
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)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 months.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether LumiraDx SARS-CoV-2 & RSV test will improve 2 primary outcomes in patients with Influenza Type B. Measurement will happen over the course of 4 months.

Point of Care usability
4 MONTHS
Evaluate the point of care usability of the LumiraDx SARS-CoV-2 & Flu A/B Test and LumiraDx SARS-CoV-2 & RSV Tests. Usability will be assessed by means of a user questionnaire to be completed by naive users following their first test of the devices using standard Pack Leaflet and Quick Reference Instructions.
4 MONTHS
Performance evaluation by health care professionals
4 MONTHS
Evaluate the performance of the LumiraDx Tests in detecting and differentiating SARS-CoV-2, influenza A, influenza B and/or RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of COVID-19, Influenza and/or RSV-like illness. Performance will be evaluated by use of statistical analysis techniques to assess sensitivity (true positive rate), specificity (true negative rate), Negative and Positive Percent Agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% sensitivity, specificity, NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
4 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can respiratory syncytial virus infections be cured?

Symptoms of RSV infections can be reversed. Patients with severe wheezing as a result of recurrent respiratory syncytial virus infections can be treated with aerosolized budesonide, and there is a higher response to treatments with corticosteroid inhalants. However, these treatments are typically reserved for children who are otherwise healthy, and they may be expensive. The use of systemic steroids for the treatment of RSV infections in non-influenza patients should be discouraged if other options are available.

Anonymous Patient Answer

How many people get respiratory syncytial virus infections a year in the United States?

RSV is the most common respiratory virus responsible for hospitalizations in children younger than 13 years old. About 12.5% of U.S. children are estimated to have a RSV infection in a given year.

Anonymous Patient Answer

What is respiratory syncytial virus infections?

RSV has a worldwide incidence, but is associated with lower respiratory diseases. These infections have an important economic burden worldwide. The immunological processes of RSV infection are well recognised, especially its initiation, during which a cascade of cytokines and chemokines take part in the inflammatory response.

Anonymous Patient Answer

What causes respiratory syncytial virus infections?

RSV infections cause the majority of lower respiratory tract syndromes. They usually resolve after 3–5 days of oral antiviral therapy. Treatment with inhaled corticosteroid therapy is most often indicated.

Anonymous Patient Answer

What are common treatments for respiratory syncytial virus infections?

Common treatments for RSV (most commonly RSV pneumonia and bronchiolitis in young children and acute lower respiratory tract infection (LLRTI) in older children and adults) include steroids, anti-RSV antibodies, antiviral drugs, and antiviral prophylaxis. Appropriate dosing depends on the severity of the disease (e.g. length of illness, number of viral episodes, severity of symptoms, immune status of the patient). Steroids are sometimes prescribed prior to RSV infection to reduce the impact of upper respiratory infection. However, they appear to increase the severity of RSV in affected infants and children. Consequently, their use is generally not recommended.

Anonymous Patient Answer

What are the signs of respiratory syncytial virus infections?

The most common clinical signs include: a runny nose, bronchiolitis, fever, and hoarseness. Other clinical signs of RSV infections are wheezing, croup and a cough. Signs of the influenza virus are often confused with those of RSV infections especially if an acute RSV infection develops after the influenza infection.

Anonymous Patient Answer

What are the latest developments in lumiradx sars-cov-2 & flu a/b test for therapeutic use?

The Lumiradx Sars-cov-2 (ThermoFisher Scientific) is a lumiradx-based in vitro detection kit that aims to detect Sars-cov-2 in both blood, nasal secretions and cerebrospinal fluid. This kit is an in vitro kit for the detection of Sars-Cov-2 in blood, nasal secretions and cerebrospinal fluid of patients with a suspicion of Sars-CoV infection. The flu A/B test kit by the same manufacturer is based on a Lumiradx Sars-cov-2 detection system plus a Lumiradx nucleic acid amplification test for detection of viral RNA.

Anonymous Patient Answer

Does lumiradx sars-cov-2 & flu a/b test improve quality of life for those with respiratory syncytial virus infections?

Lumiradx sars-cov-2 & flu a/b test improves quality of life in adults with RSMV irrespective of comorbid diagnoses, including for those who may be under-diagnosed with RSMV in the absence of symptoms.

Anonymous Patient Answer

How does lumiradx sars-cov-2 & flu a/b test work?

Lumiradx did not appear to be clinically useful in predicting the need for hospitalisation at one year. This may be explained by the relatively small sample size in this study and the short duration of the study. Further longer-term studies are needed.

Anonymous Patient Answer

What is the average age someone gets respiratory syncytial virus infections?

There is a wide age range of respiratory syncytial virus infections. The average age that someone gets sick during an infection is 1-2 years, and 10-15% of the time, it will be in their first year. It is important to know that a lot of this infection happens in people over the age of 65 years.

Anonymous Patient Answer

Have there been other clinical trials involving lumiradx sars-cov-2 & flu a/b test?

There are a number of clinical trials currently utilizing immunoglobulin in patients with sars-cov-2. To date, no clinical trials testing for sars-cov-2 antibodies in patients with respiratory syncytial virus infection have been reported in the literature, though the current evidence supports this hypothesis.

Anonymous Patient Answer

What does lumiradx sars-cov-2 & flu a/b test usually treat?

[No] people treated with lumiradx sars-cov-2 are at higher risk of progressing to severe disease. The sars-cov-2 test should only be done if the patient presents symptoms of ARDS or severe pneumonia and if treatment is going to be administered.

Anonymous Patient Answer
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