Sars-CoV-2 InfectionAIDINCT05220306
AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation
A study testing Monitoring of vital signs in people with Sars-CoV-2 Infection, run by AIDAR Health, Inc. at 1 site in United States.
Trial summary
The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Monitoring of vital signs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older
- Unvaccinated individuals, or individuals who have received only 1 dose of an mRNA vaccine
- Individuals who have received a positive SARS-CoV-2 result within 24-48 hours (lab-based PCR or antigen test)
- Willing and able to provide informed consent
- Ability to read, write, and comprehend English
- Have no functional limitation that would impede the use of the MouthLab device
- Willing to provide access to health information via electronic health records (EHR)
Who cannot join
- Currently receiving hospice care
- Have a left ventricular assist device
- Left-sided hemiplegia or any other motor deficits that may restrict the use of the device.
- individuals with cognitive deficits that impede their ability to comprehend and give informed consent.
- Individuals who are enrolled in any other investigational research studies of SARS-CoV2 or COVID-19
- Individuals who are treated with monoclonal antibody therapy prior to diagnosis
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- Individuals who are admitted to a hospital or acute care facility at the time of diagnosis
- Individuals with pacemakers or implanted cardio-defibrillators (ICDs)
- History of hemoptysis, pneumothorax, thoracic or abdominal aneurysm, pulmonary embolism, or stroke
- History of unstable cardiovascular status, including recent myocardial infarction (MI within 30 days), unstable angina, or uncontrolled hypertension Color blindness
- Chest, abdominal or eye surgery within the preceding 14 days
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation (Phase II). Up to 500 unvaccinated and partially vaccinated subjects will be included (up to 100 in Phase I and up to 400 in Phase II).
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Monitoring of vital signs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of vital signsDevice
The MouthLab is a hand-held device. The user holds the unit in their left hand with the Mouthpiece between the teeth and lips and breathes normally into the device for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | Participants will use the MouthLab device for monitoring their vital signs Receives: Device: Monitoring of vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation
Accurately collect trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 captured with the MouthLab to identify individuals who are at risk of clinical decompensation. (Phase 1)
Measured: Daily for 60 days
AIDI evaluation
Evaluate trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 which are captured with the MouthLab device to evaluate the ability of the Aidar COVID-19 Decompensation Index (AIDI) to accurately identify individuals at risk of clinical decompensation. (Phase 2)
Measured: Daily for 60 days
Secondary outcomes (2)
Usability of MouthLab device
Usability of the MouthLab device will be assessed via a questionnaire at study exit
Measured: At 60 days
Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions
Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions
Measured: Day 0 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start27 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022 (estimated)
Why it stopped: No eligible patients could be found and funding was lost
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase I/Derivation Cohort (100 patients): This phase will use the MouthLab to capture vital signs. This data will help create Aidar's algorithm-based decompensation index (AIDI) that utilizes changes in vital signs to identify individuals who test positive for SARS-CoV-2 or with COVID-19 infection and are at risk of developing clinical decompensation. Phase II/Validation Cohort (400 patients): This phase will use the MouthLab to capture vital signs and use Aidar's algorithm-based decompensation index (AIDI) to identify individuals at risk of clinical decompensation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDAR Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Sujith Shetty, MD, Principal investigator, Avania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220306
- Sponsor's protocol ID
- ADR04-AIDI-C-21
- Acronym
- AIDI
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mathew J, Pagliaro JA, Elumalai S, Wash LK, Ly K, Leibowitz AJ, Vimalananda VG. Developing a Multisensor-Based Machine Learning Technology (Aidar Decompensation Index) for Real-Time Automated Detection of Post-COVID-19 Condition: Protocol for an Observational Study. JMIR Res Protoc. 2025 Mar 27;14:e54993. doi: 10.2196/54993.
PubMed 40146983
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation
- ClinicalTrials.gov ID
- NCT05220306
- Acronym / sponsor ID
- AIDI / ADR04-AIDI-C-21
- Conditions
- Sars-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No eligible patients could be found and funding was lost
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AIDAR Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation (Phase II). Up to 500 unvaccinated and partially vaccinated subjects will be included (up to 100 in Phase I and up to 400 in Phase II).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I/Derivation Cohort (100 patients): This phase will use the MouthLab to capture vital signs. This data will help create Aidar's algorithm-based decompensation index (AIDI) that utilizes changes in vital signs to identify individuals who test positive for SARS-CoV-2 or with COVID-19 infection and are at risk of developing clinical decompensation. Phase II/Validation Cohort (400 patients): This phase will use the MouthLab to capture vital signs and use Aidar's algorithm-based decompensation index (AIDI) to identify individuals at risk of clinical decompensation.
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Monitoring of vital signsParticipants will use the MouthLab device for monitoring their vital signs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18 years of age or older
- Unvaccinated individuals, or individuals who have received only 1 dose of an mRNA vaccine
- Individuals who have received a positive SARS-CoV-2 result within 24-48 hours (lab-based PCR or antigen test)
- Willing and able to provide informed consent
- Ability to read, write, and comprehend English
Key exclusion criteria (12 listed)
- Currently receiving hospice care
- Have a left ventricular assist device
- Left-sided hemiplegia or any other motor deficits that may restrict the use of the device.
- individuals with cognitive deficits that impede their ability to comprehend and give informed consent.
- Individuals who are enrolled in any other investigational research studies of SARS-CoV2 or COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of vital signsThe MouthLab is a hand-held device. The user holds the unit in their left hand with the Mouthpiece between the teeth and lips and breathes normally into the device for 30 seconds. | Device | Device Arm |
Primary outcome
Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation
Time frame: Daily for 60 days
Accurately collect trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 captured with the MouthLab to identify individuals who are at risk of clinical decompensation. (Phase 1)
AIDI evaluation
Time frame: Daily for 60 days
Evaluate trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 which are captured with the MouthLab device to evaluate the ability of the Aidar COVID-19 Decompensation Index (AIDI) to accurately identify individuals at risk of clinical decompensation. (Phase 2)
2 secondary outcomes
Usability of MouthLab device
Time frame: At 60 days
Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions
Time frame: Day 0 to Day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40146983Mathew J, Pagliaro JA, Elumalai S, Wash LK, Ly K, Leibowitz AJ, Vimalananda VG. Developing a Multisensor-Based Machine Learning Technology (Aidar Decompensation Index) for Real-Time Automated Detection of Post-COVID-19 Condition: Protocol for an Observational Study. JMIR Res Protoc. 2025 Mar 27;14:e54993. doi: 10.2196/54993.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujith Shetty, MD principal investigator
Avania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of vital signs in people with Sars-CoV-2 Infection, run by AIDAR Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation (time frame: Daily for 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 27 Oct 2026.