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Diagnostic Test

Group C: Sample Collection for Coronavirus (ASPIRE Trial)

N/A

Waitlist Available

Led By Andre Gvozden

Research Sponsored by LumiraDx UK Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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. The onset of these symptoms will be recorded. or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

ASPIRE Trial Summary

This trial will test a new test to detect COVID-19. It will compare it to an existing test to see if it's accurate.

Who is the study for?

This trial is for people showing COVID-19 symptoms like fever, cough, or loss of taste/smell, or those with a recent positive PCR test. It's open to all ages and sexes. Children must have guardian consent and agree to study procedures.Check my eligibility

What is being tested?

The LumiraDx SARS-CoV-2 Ag assay is being tested against a reference method to see how well it detects the virus using samples from nasal swabs, throat swabs, fingerstick blood, or saliva.See study design

What are the potential side effects?

There may be minor side effects from sample collection such as discomfort in the nose or throat from swabs, pain at the finger prick site for blood collection, and gagging with saliva collection.

ASPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I show symptoms of COVID-19 or have a positive test result within the last 48 hours.

ASPIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Performance Evaluation

ASPIRE Trial Design

5Treatment groups

Experimental Treatment

Group I: Group E: Sample CollectionExperimental Treatment1 Intervention

Nasal swab

Group II: Group D: Sample CollectionExperimental Treatment2 Interventions

Nasopharyngeal Swab and Saliva Sample Collection

Group III: Group C: Sample CollectionExperimental Treatment3 Interventions

Nasal Swab, Throat Swab and Saliva Sample Collection

Group IV: Group B: Sample CollectionExperimental Treatment3 Interventions

Nasal swab, Capillary Blood (from fingerstick) and Saliva Collection

Group V: Group A: Sample CollectionExperimental Treatment2 Interventions

Nasal Swab and Saliva Sample Collection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nasopharyngeal swab

2021

N/A

~15360

Throat swab

2020

N/A

~2820

Fingerstick

2021

N/A

~420

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

LumiraDx UK LimitedLead Sponsor

15 Previous Clinical Trials

33,356 Total Patients Enrolled

Andre GvozdenPrincipal InvestigatorGvozden Pediatrics

1 Previous Clinical Trials

2,000 Total Patients Enrolled

Melanie HoppersPrincipal InvestigatorPhysicians Quality Care of Jackson

1 Previous Clinical Trials

153 Total Patients Enrolled

Media Library

Fingerstick (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04557046 — N/A

Coronavirus Research Study Groups: Group C: Sample Collection, Group E: Sample Collection, Group A: Sample Collection, Group B: Sample Collection, Group D: Sample Collection

Coronavirus Clinical Trial 2023: Fingerstick Highlights & Side Effects. Trial Name: NCT04557046 — N/A

Fingerstick (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557046 — N/A

Frequently Asked Questions

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

Is enrollment in this trial open at present?

"The details on clinicaltrials.gov indicate that this study is not recruiting patients anymore. Although the trial was initially publicized in June 2020, it has not been updated since March 2023. Fortunately, 896 other trials are currently looking for participants to join their research projects."

Answered by AI

How many locations are participating in the research trial?

"This trial is currently being conducted at 6 distinct sites, including Altamonte Springs, Kissimmee and Plano; the other locations are also easily accessible. To minimize travel demands for participants, it's best to choose a clinic that is closest to your residence."

Answered by AI

Recent research and studies

Infectious Diseases and TherapyJournal

Performance Evaluation of the Microfluidic Antigen Lumiradx Sars-cov-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms

Ellis, Jayne E., Poppy Guest, Vicki Lawson, Julia Loecherbach, Nigel Lindner, and Andrew McCulloch. 2022. “Performance Evaluation of the Microfluidic Antigen Lumiradx Sars-cov-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms”. Infectious Diseases and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40121-022-00696-8.

clinicaltrials.govStudy

Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test

2020. "Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04557046.