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Antigen Test

Group C: Sample Collection for COVID-19 (ASPIRE-2 Trial)

N/A

Waitlist Available

Led By Frank Calcagno, MD

Research Sponsored by LumiraDx UK Limited

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

ASPIRE-2 Trial Summary

This trial will compare the LumiraDx SARS-CoV-2 Ag ULTRA assay to a reference method to see how well it performs.

Eligible Conditions

COVID-19
Coronavirus

ASPIRE-2 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-2 Trial Design

4Treatment groups

Experimental Treatment

Group I: Group D: Sample CollectionExperimental Treatment1 Intervention

2x Nasal Swab Sample Collection

Group II: Group C: Sample CollectionExperimental Treatment2 Interventions

1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection for sample pooling

Group III: Group B: Sample CollectionExperimental Treatment2 Interventions

1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection

Group IV: Group A: Sample CollectionExperimental Treatment1 Intervention

2x Nasopharyngeal Swab Sample Collection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nasopharyngeal swab

2021

N/A

~15360

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LumiraDx UK LimitedLead Sponsor

15 Previous Clinical Trials

34,090 Total Patients Enrolled

7 Trials studying COVID-19

9,955 Patients Enrolled for COVID-19

Frank Calcagno, MDPrincipal InvestigatorCyn3rgy Research

Rogelio Machuca, MDPrincipal InvestigatorThe Machuca Foundation, Inc.

Frequently Asked Questions

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

Are there openings for enrollees in this research study?

"Affirmative. The information stored on clinicaltrials.gov demonstrates that this research venture is currently seeking patients, having been created on June 30th 2022 and most recently edited August 17th 2022. This trial intends to recruit 400 participants from 6 distinct locations."

Answered by AI

How widely distributed is this clinical trial?

"Six medical centres are currently running this trial, including Cahaba Research, Inc. in Birmingham as well as Healthy Life Research, Inc. in Miami and Zion Urgent Care in Katy among other sites."

Answered by AI

To what extent is participation in this clinical research endeavor being sought?

"The sponsor, LumiraDx UK Limited, requires 400 qualified participants to conduct the trial from two distinct sites - Cahaba Research in Birmingham Alabama and Healthy Life Research in Miami Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05506618.