HealthyNCT04748445

Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.

An observational study of Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SARS-CoV-2/Influenza/RSV RT-PCR
How many people: 9,151 participants
Where: 1 siteUnited States
Study dates: 12 Apr 2021to 22 Apr 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Study population: Planned enrollment of approximately 8700 participants 18 years of age or older in order to have a total of N of 100 participants with (1) confirmed negative SARS-CoV-2, RSV or Influenza RT-PCR (swab #1) and (2) confirmed positive SARS-CoV-2 RT-PCR, influenza virus or RSV (swab #2) symptomatic completers.

Who may be able to join

Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
Male or female participants ≥18 years of age (or the minimum state specific age of consent if >18), at Screening visit.
Type of Participant and Disease Characteristics:
Participants who are willing and able to comply with daily symptom and voice assessments on the electronic diary application and other study procedures, including self-collection of nasal swabs.
Expected to be available for the duration of the study.

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Informed Consent:
4. Capable of giving signed informed consent
-

Who cannot join

Participants are excluded from the study if any of the following criteria apply:
Participants who self-report any medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent, or in the investigator's judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
Participants who have been vaccinated with COVID-19 vaccine or are planning to get vaccinated during study participation.
Participants can continue to use all other prescription or non-prescription medications.
Prior/Concurrent Clinical Study Experience:

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Previous vaccination with any licensed or investigational RSV vaccine or are planning to get vaccinated during study participation.
Previous administration with an investigational drug within 30 days of enrollment (or as determined by the local requirement) or planning to participate in an interventional trial during study conduct.
Diagnostic Assessments:
Screening diagnostic assessments are not required for eligibility purposes.
Other Exclusions:
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator including vendors, and their respective family members.
Participants who use a mobile device that does not meet the minimum requirements of the Electronic diary.
Participants who have previously been enrolled in the study cannot be re-enrolled.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ochsner Clinic Foundation
New Orleans, Louisiana, 70121

Other trials in United States

About this study

Official title: Acute Respiratory Illness Surveillance (ARIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study.

The purpose of the AcRIS study is to obtain data to characterize the relationship between symptoms and voice features for (reverse transcription polymerase chain reaction (RT-PCR) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus, or Respiratory Syncytial Virus (RSV) positive participants with acute viral respiratory illness. This data will be used as the basis to build voice and symptom algorithm(s) for detection and monitoring of these illnesses. This would benefit vaccine development across several key disease areas, including SARS-CoV-2, influenza virus and RSV.

The study also models concepts of more efficient "flexible" clinical trials involving not only voice capture, but also web-based participant recruitment, enhanced participant engagement, and remote sample collection that could make future clinical studies more efficient. The clinical data obtained in this observational study could provide the documentation of the technology's performance needed to enable its deployment in future interventional studies.

Read the detailed description

Each subject will be required to stay in the study for 6 weeks. If the participant tests positive for any of the three viruses at swab #1 or swab #2, they will continue the study until the end of Week 8.

Participants will record acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and, should they become ill, the sick state, utilizing the Electronic diary on their Mobile application. Once enrolled, the participant will start recording symptoms and voice in the Electronic diary, with daily time commitment to this portion of the study expected to be 2-4 minutes. Two nasal self-swab collection kits will be ordered for delivery to the participant once they are enrolled in the study. The participant will be asked to self-swab when the test kit arrives (swab #1). The kit, including the specimen, will be returned to the central lab for RT-PCR SARS-CoV2/Influenza/RSV RT-PCR testing. The participant is expected to complete 3 phonemes and 5 lines of reading each day, in addition to score the self-reported symptoms in the Electronic diary. If participants become sick (self-report) with new or increased symptoms of acute respiratory illness symptoms, they will be asked to self-swab (swab #2) and return the sample for central SARS-CoV-2/Influenza/RSV RT-PCR testing. If the participant does not develop any new or increased symptoms between swab #1 and end of Week 6, they will obtain a self-swab (swab #2) at Day 42.

If the participant tests positive for any of the three viruses at swab #1 or swab #2, they will continue the study until end of week 8. If they test negative for the three viruses at swab #1 and swab #2, they will exit the study at approximately the end of week 6 when the test results are returned. The results of the RT-PCR testing will be shared with participants.

Conditions: Healthy
Being tested: SARS-CoV-2/Influenza/RSV RT-PCR
Keywords: Covid-19, Covid 19, Coronavirus, SARS-CoV-2, Flu, Influenza, RSV, Respiratory syncytial virus, Respiratory illness, Acute respiratory illness, remote trial, voice, AcRIS
Medical subject headings: COVID-19, Coronavirus Infections, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SARS-CoV-2/Influenza/RSV RT-PCRDiagnostic test
nasal swab

Study groups in NCT04748445
Study group	Role	What they receive
All participants		Not described Receives: Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Symptoms (fever, cough, difficult breathing, fatigue, runny nose, stuffy/blocked nose, sore throat, loss of taste/smell, chills, muscle pain, diarrhea, vomiting, headache, nausea, rigors, wheezing) recorded at least once daily in e-diary for 8 weeks \& rated 0:none to 4:severe for fever \& 0:none to 7:severe for other symptoms. Total symptom score=sum of all symptom scores in a recording session \& mean of daily total symptom score=average across available sessions for each day, range=0 to 109, higher value=more severe total symptoms. Baseline=average of values up to 7 days before 1st occurrence of new/increased symptoms. If no data in 7 days, average of endpoint values for closest 3 days prior to 7 days used as baseline. Linear mixed effect model used for analysis for change from baseline in each symptom versus day during well to sick period, with slope (without intercept) included as fixed effects and random effects. Fixed effect of slope, as population level estimate, was reported.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56
Participants recorded voice features such as pitch, jitter once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Max Phonation Time: duration that sound is held for. Jitter Local Absolute: average absolute difference between consecutive periods. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
Harmonicity, flatness, shimmer recorded and assessed by phonemes: 'eee' and 'mmm' for 4 seconds, "ahh" sustained and 5-sentence reading passage. Cepstral Peak Prominence: voice quality measure. Harmonicity: degree of periodicity in signal. mel frequency cepstral coefficients (MFCC) mean: quantifies shape of spectrum. MFCC std: quantifies variation in spectral shape over time. Signal-to-noise ratio (SNR): how loud signal is compared to background. Shimmer Local dB: average absolute difference between amplitudes of consecutive periods (how unsteady sound intensity is across neighboring glottal pulses). Spectral Flatness: quantifies how tone-like a signal is based on spectral distribution. Third Octave Band: energy in 200 Hz third octave band relative to total. VLHR: degree of nasality. Linear mixed effect model used for analysis. Fixed effect of slope, as population level estimate is reported. Individual exponential factors for data presented have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
Voice features were recorded once daily in an electronic diary for 8 weeks. Assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Coefficient of Variation of F0: measures variation in pitch over time. MFCC 1st order delta: time-averaged estimate of first derivate of the MFCCs. MFCC 2nd order delta: time-averaged estimate of the second derivative of the MFCCs. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56
Participants recorded voice features such as entropy once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Entropy: Shannon entropy of the spectral distribution. Quantifies tonailty similar to spectral flatness. "EE_Entropy" and "MM_Entropy" refer to this same measure computed on the "eee" and "mmm" phonemes, respectively. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Formant: frequency at which the vocal tract produces an acoustic resonance. Formant Bandwidth: the spectral width of the acoustic resonance. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. The voiced frames rate indicates how much of the sound is voiced. EE and MM refer to the sounds on which the measure is computed. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56
Voice features such as jitter were recorded once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Jitter Local: average absolute difference between consecutive periods divided by the average period as a percentage. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56
Voice features such as shimmer were once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Shimmer Local: average absolute difference between the amplitudes of consecutive periods divided by the average amplitude as a percentage. Indicates how unsteady the sound intensity is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Measured: Baseline up to Day 56
Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Baseline was average of endpoint values up to 7 days before first occurrence of new/increased symptoms. If participant had no data in 7 days, average of endpoint values for closest 3 days prior to these 7 days was used as baseline. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor (i.e. LSM*10^-2, SE*10^-3) in addition to values mentioned.
Measured: Baseline up to Day 56

Secondary outcomes (7)

Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
In this outcome measure, percentage of compliant days in total days of self-reported symptoms and total days of voice recordings as entered in the electronic diary were reported. Compliant days were calculated for the following and expressed as percentage: symptom compliance = number of compliant days of self-reported symptoms divided by the total number of days in the study. Voice compliance (expressed as percentage) = number of compliant days of completed voice recordings divided by the total number of days in the study. Partial voice compliance (expressed as percentage) = number of compliant days of partially completed voice recordings divided by the total number of days in the study. Symptom and voice compliance (expressed as percentage) = number of compliant days of self-reported symptoms and completed voice recordings divided by the total number of days in the study. Participants who experienced technical issues due to study operational errors were excluded.
Measured: Day 1 up to Day 56
Percentage of Quality Voice Recordings
In this outcome measure, percentage was calculated over the number of days that the participant was able to complete the task for each recording. Participants were required to record their daily voice in electronic diary and the assessment included 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Quality recordings were defined as recordings exceeding signal-to-noise (SNR) and duration thresholds (i.e. SNR >= 20 decibels [dB] that have duration >= 3 seconds for phoneme and >= 10 seconds for reading tasks). In the case of multiple electronic diary sessions per day, the session with the highest quality voice recordings for that day was used in this analysis.
Measured: Day 1 up to Day 56
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
In this outcome measure, percentage of participants with valid self-swab 1 and 2 results positive for SARS-COV-2, Flu A, Flu B, RSV and SARS-CoV-2 and/or Influenza (Flu A/Flu B) and/or RSV were reported.
Measured: Day 2 up to Day 43
Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
In this outcome measure, percentage of participants who administered self-swab 1, self-swab 2 and self-swab 1 and 2 excluding participants who experienced technical issues due to study operational errors were reported.
Measured: Day 2 up to Day 43
Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary
In this outcome measure, number of days from symptom onset (reporting new or increased symptoms in the electronic diary) to the day of recording Swab 2 day in the electronic diary averaged across participants who administered self-swab 2 was reported.
Measured: Day 2 Up to Day 43
Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset
In this outcome measure, 1) participants (par) who administered (adm) self-swab 2 (SS2) before Week 6 (W6) divided by the number of participants who reported new or increased (inc) symptoms (sym) in the electronic diary (e-diary) before W6 and 2) number of participants who reported new or increased symptoms in the e-diary before Week 6 divided by the number of participants who administered self-swab 2 before Week 6 were reported in percentage.
Measured: Day 2 Up to Day 43
Percentage of Participants Who Administered Self-swabs With Valid Results
In this outcome measure, percentage of participants with valid (positive or negative) self-swab results for SARS-CoV-2, Flu A, Flu b and RSV were reported.
Measured: Day 2 Up to Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202122 Apr 2022

First posted10 Feb 2021
Study start12 Apr 2021
Primary completion22 Apr 2022
Study completion22 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 9,151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04748445
Sponsor's protocol ID: X9001293
Status last verified: Feb 2024
First submitted: 5 Feb 2021
Last updated: 23 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Chappie K, Kell S, Qi D, Selig J, Christakis Y, Moreno X, Severson J, Best A, Wacnik P, Santamaria M, Zhang Y, Fry BA, Mather RJ. Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study. J Voice. 2025 Jun 23:S0892-1997(25)00201-2. doi: 10.1016/j.jvoice.2025.05.016. Online ahead of print.
PubMed 40555587
Santamaria M, Christakis Y, Demanuele C, Zhang Y, Tuttle PG, Mamashli F, Bai J, Landman R, Chappie K, Kell S, Samuelsson JG, Talbert K, Seoane L, Mark Roberts W, Kabagambe EK, Capelouto J, Wacnik P, Selig J, Adamowicz L, Khan S, Mather RJ. Longitudinal voice monitoring in a decentralized Bring Your Own Device trial for respiratory illness detection. NPJ Digit Med. 2025 Apr 11;8(1):202. doi: 10.1038/s41746-025-01584-4.
PubMed 40210993

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The sponsor has not listed a contact. The official record may have more details.

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Respiratory Illness Surveillance (ARIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study.
ClinicalTrials.gov ID: NCT04748445
Acronym / sponsor ID: X9001293
Conditions: Healthy
Keywords: Covid-19, Covid 19, Coronavirus, SARS-CoV-2, Flu, Influenza, RSV, Respiratory syncytial virus
Study type: Observational
Recruitment status: Completed
Enrolment: 9,151 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Apr 2021 (actual)
Primary completion: 22 Apr 2022 (actual)
Study completion: 22 Apr 2022 (actual)
First posted: 10 Feb 2021 (actual)
Results: Posted 23 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Planned enrollment of approximately 8700 participants 18 years of age or older in order to have a total of N of 100 participants with (1) confirmed negative SARS-CoV-2, RSV or Influenza RT-PCR (swab #1) and (2) confirmed positive SARS-CoV-2 RT-PCR, influenza virus or RSV (swab #2) symptomatic completers.

Key inclusion criteria (9 listed)

Participants are eligible to be included in the study only if all of the following criteria apply:
Male or female participants ≥18 years of age (or the minimum state specific age of consent if >18), at Screening visit.
Participants who are willing and able to comply with daily symptom and voice assessments on the electronic diary application and other study procedures, including self-collection of nasal swabs.
Expected to be available for the duration of the study.
4. Capable of giving signed informed consent

Key exclusion criteria (14 listed)

Participants who self-report any medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent, or in the investigator's judgment, make the participant inappropriate for the study.
Participants who have been vaccinated with COVID-19 vaccine or are planning to get vaccinated during study participation.
Participants can continue to use all other prescription or non-prescription medications.
Previous vaccination with any licensed or investigational RSV vaccine or are planning to get vaccinated during study participation.
Previous administration with an investigational drug within 30 days of enrollment (or as determined by the local requirement) or planning to participate in an interventional trial during study conduct.

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
SARS-CoV-2/Influenza/RSV RT-PCRnasal swab	Diagnostic test	All participants

Primary outcome

Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Symptoms (fever, cough, difficult breathing, fatigue, runny nose, stuffy/blocked nose, sore throat, loss of taste/smell, chills, muscle pain, diarrhea, vomiting, headache, nausea, rigors, wheezing) recorded at least once daily in e-diary for 8 weeks \& rated 0:none to 4:severe for fever \& 0:none to 7:severe for other symptoms. Total symptom score=sum of all symptom scores in a recording session \& mean of daily total symptom score=average across available sessions for each day, range=0 to 109, higher value=more severe total symptoms. Baseline=average of values up to 7 days before 1st occurrence of new/increased symptoms. If no data in 7 days, average of endpoint values for closest 3 days prior to 7 days used as baseline. Linear mixed effect model used for analysis for change from baseline in each symptom versus day during well to sick period, with slope (without intercept) included as fixed effects and random effects. Fixed effect of slope, as population level estimate, was reported.
Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Participants recorded voice features such as pitch, jitter once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Max Phonation Time: duration that sound is held for. Jitter Local Absolute: average absolute difference between consecutive periods. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Harmonicity, flatness, shimmer recorded and assessed by phonemes: 'eee' and 'mmm' for 4 seconds, "ahh" sustained and 5-sentence reading passage. Cepstral Peak Prominence: voice quality measure. Harmonicity: degree of periodicity in signal. mel frequency cepstral coefficients (MFCC) mean: quantifies shape of spectrum. MFCC std: quantifies variation in spectral shape over time. Signal-to-noise ratio (SNR): how loud signal is compared to background. Shimmer Local dB: average absolute difference between amplitudes of consecutive periods (how unsteady sound intensity is across neighboring glottal pulses). Spectral Flatness: quantifies how tone-like a signal is based on spectral distribution. Third Octave Band: energy in 200 Hz third octave band relative to total. VLHR: degree of nasality. Linear mixed effect model used for analysis. Fixed effect of slope, as population level estimate is reported. Individual exponential factors for data presented have been mentioned in respective row title.
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Voice features were recorded once daily in an electronic diary for 8 weeks. Assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Coefficient of Variation of F0: measures variation in pitch over time. MFCC 1st order delta: time-averaged estimate of first derivate of the MFCCs. MFCC 2nd order delta: time-averaged estimate of the second derivative of the MFCCs. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Participants recorded voice features such as entropy once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Entropy: Shannon entropy of the spectral distribution. Quantifies tonailty similar to spectral flatness. "EE_Entropy" and "MM_Entropy" refer to this same measure computed on the "eee" and "mmm" phonemes, respectively. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Formant: frequency at which the vocal tract produces an acoustic resonance. Formant Bandwidth: the spectral width of the acoustic resonance. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. The voiced frames rate indicates how much of the sound is voiced. EE and MM refer to the sounds on which the measure is computed. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Voice features such as jitter were recorded once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Jitter Local: average absolute difference between consecutive periods divided by the average period as a percentage. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Voice features such as shimmer were once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Shimmer Local: average absolute difference between the amplitudes of consecutive periods divided by the average amplitude as a percentage. Indicates how unsteady the sound intensity is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.
Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56
Time frame: Baseline up to Day 56
Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Baseline was average of endpoint values up to 7 days before first occurrence of new/increased symptoms. If participant had no data in 7 days, average of endpoint values for closest 3 days prior to these 7 days was used as baseline. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor (i.e. LSM*10^-2, SE*10^-3) in addition to values mentioned.

7 secondary outcomes

Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
Time frame: Day 1 up to Day 56
Percentage of Quality Voice Recordings
Time frame: Day 1 up to Day 56
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Time frame: Day 2 up to Day 43
Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
Time frame: Day 2 up to Day 43
Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary
Time frame: Day 2 Up to Day 43
Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset
Time frame: Day 2 Up to Day 43
Percentage of Participants Who Administered Self-swabs With Valid Results
Time frame: Day 2 Up to Day 43

Results and safety

Results posted to the registry on 23 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	9,151	8,520

Primary outcome: Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56

Time frame: Baseline up to Day 56. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	All Participants n = 126
Chills	0.065 (0.0110)
Cough	0.281 (0.0361)
Diarrhea	0.036 (0.0077)
Difficulty breathing	0.113 (0.0263)
Fatigue	0.259 (0.0319)
Fever	0.029 (0.0050)
Headache	0.194 (0.0281)
Loss of taste or smell	0.103 (0.0266)

All Participants: Slope: 0.065 (90% CI 0.046 to 0.083), p <.0001, Mixed Models Analysis
All Participants: Slope: 0.281 (90% CI 0.221 to 0.341), p <.0001, Mixed Models Analysis
All Participants: Slope: 0.036 (90% CI 0.023 to 0.048), p <.0001, Mixed Models Analysis

Population analysed: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study were included. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

Primary outcome: Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56

Time frame: Baseline up to Day 56. Least squares mean (Standard Error). Unit: Seconds

Measure	All Participants n = 126
AHH_Max Phonation Time: LSM (10^-1), SE (10^-2)	-1.519 (2.769)
EE_Jitter Local Absolute: LSM (10^-8)	6.899 (0)
MM_Jitter Local Absolute: LSM (10^-7)	-1.743 (0)

All Participants: Slope: -1.519 (90% CI -1.978 to -1.060), p <.0001, Mixed Models Analysis
All Participants: Slope: 6.899, p <.0001, Mixed Models Analysis
All Participants: Slope: -1.743, p <.0001, Mixed Models Analysis

Population analysed: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

Primary outcome: Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56

Time frame: Baseline up to Day 56. Least squares mean (Standard Error). Unit: Decibel

Measure	All Participants n = 126
EE_Cepstral Peak Prominence LSM (10^-3), SE (10^-2)	-1.326 (1.174)
EE_Harmonicity LSM (10^-3), SE (10^-2)	7.667 (1.741)
EE_MFCC mean 01 LSM (10^0), SE (10^-1)	1.268 (2.820)
EE_MFCC mean 02 LSM (10^-1), SE (10^-1)	-1.752 (2.127)
EE_MFCC mean 03 LSM (10^-1), SE (10^-1)	1.390 (1.262)
EE_MFCC mean 04 LSM (10^-1), SE (10^-1)	-1.407 (1.194)
EE_MFCC mean 05 LSM (10^-3), SE (10^-2)	-4.466 (8.869)
EE_MFCC mean 06 LSM (10^-1), SE (10^-2)	-1.572 (9.127)

All Participants: Slope: -1.326 (90% CI -2.079 to 1.814), p = 0.9103, Mixed Models Analysis
All Participants: Slope: 0.007667 (90% CI -0.02119 to 0.03653), p = 0.6605, Mixed Models Analysis
All Participants: Slope: 1.268 (90% CI 0.8012 to 1.736), p <.0001, Mixed Models Analysis

Population analysed: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Primary outcome: Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56

Time frame: Baseline up to Day 56. Least squares mean (Standard Error). Unit: Unitless

Measure	All Participants n = 126
EE_Coefficient of Variation F0 LSM (10^-4), SE (10^-4)	2.975 (3.383)
EE_MFCC 1st order delta 01 LSM (10^-3), SE (10^-3)	-5.601 (2.751)
EE_MFCC 1st order delta 02 LSM (10^-3), SE (10^-3)	4.120 (1.464)
EE_MFCC 1st order delta 03 LSM (10^-3), SE (10^-3)	-3.067 (1.053)
EE_MFCC 1st order delta 04 LSM (10^-3), SE (10^-4)	2.780 (9.751)
EE_MFCC 1st order delta 05 LSM (10^-3), SE (10^-4)	-1.324 (8.289)
EE_MFCC 1st order delta 06 LSM (10^-4), SE (10^-4)	-2.606 (9.707)
EE_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4)	-5.071 (7.593)

All Participants: Slope: 2.975 (90% CI -2.631 to 8.580), p = 0.3809, Mixed Models Analysis
All Participants: Slope: -0.005601 (90% CI -0.01016 to -0.001043), p = 0.0438, Mixed Models Analysis
All Participants: Slope: 4.120 (90% CI 1.694 to 6.546), p = 0.0057, Mixed Models Analysis

Population analysed: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Maximum up to Day 56. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 9,151 (0%)	28 of 9,151 (0.3%)	0 of 9,151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40555587Chappie K, Kell S, Qi D, Selig J, Christakis Y, Moreno X, Severson J, Best A, Wacnik P, Santamaria M, Zhang Y, Fry BA, Mather RJ. Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study. J Voice. 2025 Jun 23:S0892-1997(25)00201-2. doi: 10.1016/j.jvoice.2025.05.016. Online ahead of print.
Derived from this study: PubMed 40210993Santamaria M, Christakis Y, Demanuele C, Zhang Y, Tuttle PG, Mamashli F, Bai J, Landman R, Chappie K, Kell S, Samuelsson JG, Talbert K, Seoane L, Mark Roberts W, Kabagambe EK, Capelouto J, Wacnik P, Selig J, Adamowicz L, Khan S, Mather RJ. Longitudinal voice monitoring in a decentralized Bring Your Own Device trial for respiratory illness detection. NPJ Digit Med. 2025 Apr 11;8(1):202. doi: 10.1038/s41746-025-01584-4.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Pfizer 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?

Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 (time frame: Baseline up to Day 56). The study lists 10 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 NCT04748445, which also lists 2 linked publications.

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 23 Feb 2024.