# Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation

> **NCT05364268** · — · COMPLETED · sponsor: **AudibleHealth AI, Inc.** · enrollment: 514 (actual)

## Conditions studied

- 2019 Novel Coronavirus Disease
- 2019 Novel Coronavirus Infection
- 2019-nCoV Disease
- COVID-19 Pandemic
- COVID-19 Virus Disease
- COVID-19 Virus Infection
- Coronavirus Disease 2019
- Coronavirus Disease-19
- SARS-CoV-2 Infection

## Interventions

- **DEVICE:** Diagnostic Test: Diagnostic Software as Medical Device

## Key facts

- **NCT ID:** NCT05364268
- **Lead sponsor:** AudibleHealth AI, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2022-05-04
- **Primary completion:** 2022-06-01
- **Final completion:** 2022-06-01
- **Target enrollment:** 514 (ACTUAL)
- **Last updated:** 2022-07-20

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05364268

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05364268, "Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT05364268. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*