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NCT04987918
Gazelle COVID-19 Test Clinical Accuracy Protocol
trial testing Applied Biosystems TaqPath COVID- 19 Combo Kit in Covid19 in 1,500 participants. Status unknown.
15 December 2022
Quick facts
| Lead sponsor | Hemex Health |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,500 |
| Start date | 20 August 2021 |
| Primary completion | 15 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Applied Biosystems TaqPath COVID- 19 Combo Kit
Conditions studied
- Covid19 — all drugs for Covid19 →
Sponsor
Hemex Health
Who can join
Eligibility, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04987918
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
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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 NCT04987918 (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 Hemex Health
- Last refreshed: 10 August 2022
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/NCT04987918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing