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NCT05268939: INSPIRE-2
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
NA trial testing LumiraDx SARS-CoV-2 & Flu A/B test in COVID-19 in 668 participants. Completed in 14 March 2023.
25 April 2022
Quick facts
| Lead sponsor | LumiraDx UK Limited |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 668 |
| Start date | 4 January 2022 |
| Primary completion | 25 April 2022 |
| Estimated completion | 14 March 2023 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- LumiraDx SARS-CoV-2 & Flu A/B test
- LumiraDx SARS-CoV-2 & RSV test
Conditions studied
- COVID-19 — all drugs for COVID-19 →
- Influenza A — all drugs for Influenza A →
- Influenza Type B — all drugs for Influenza Type B →
- RSV Infection — all drugs for RSV Infection →
Sponsor
LumiraDx UK Limited — full company profile →
Who can join
Eligibility, any sex, with COVID-19 or Influenza A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05268939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19
Currently open trials in the same condition.
- NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other LumiraDx UK Limited trials
Trials by the same sponsor.
- NCT05787444 — Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory · unknown
- NCT05728970 — Performance Evaluation of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care (POC · completed
- NCT05568966 — Collection of Blood Samples for New Diagnostic Devices 2 · NA · recruiting
- NCT05506618 — Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2) · NA · unknown
- NCT05403853 — A Performance Evaluation of the Lumiradx Point of Care HbA1c Device · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05268939 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LumiraDx UK Limited
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05268939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing