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NCT05175690
Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness
trial testing Diagnostic Software as Medical Device in COVID19 in 1,126 participants. Completed in 3 May 2022.
3 May 2022
Quick facts
| Lead sponsor | AudibleHealth AI, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,126 |
| Start date | 10 January 2022 |
| Primary completion | 3 May 2022 |
| Estimated completion | 3 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Diagnostic Software as Medical Device
Conditions studied
- COVID19 — all drugs for COVID19 →
Sponsor
AudibleHealth AI, Inc.
Who can join
18 and older, any sex, with COVID19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. This study will evaluate the performance of the AudibleHealth Dx in comparison to a standard of care Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test for the diagnosis of COVID-19. Bidirectional Sanger sequencing will be used to reduce the rate of false negative and false positive results. A secondary purpose of the study will be usability testing of the device for participants and providers.
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 NCT05175690
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID19
Currently open trials in the same condition.
- NCT07337382 — The Optimising Isolation, Quarantine and Distancing Study for COVID-19 · active not recruiting
- NCT04376034 — Convalescent Plasma Collection and Treatment in Pediatrics and Adults · Phase 3 · recruiting
- NCT04367883 — Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection · recruiting
Other AudibleHealth AI, Inc. trials
Trials by the same sponsor.
- NCT05364268 — Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Vali · 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 NCT05175690 (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 AudibleHealth AI, Inc.
- Last refreshed: 5 May 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/NCT05175690.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing