Healthy
Conditions
Keywords
Covid-19, Covid 19, Coronavirus, SARS-CoV-2, Flu, Influenza, RSV, Respiratory syncytial virus, Respiratory illness, Acute respiratory illness, remote trial, voice, AcRIS
Brief summary
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.
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.
Interventions
nasal swab
Sponsors
Study design
Eligibility
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1. 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: 2. 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. 3. Expected to be available for the duration of the study. Informed Consent: 4\. Capable of giving signed informed consent \-
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. 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: 2. 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: 3. Previous vaccination with any licensed or investigational RSV vaccine or are planning to get vaccinated during study participation. 4. 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: 5. Screening diagnostic assessments are not required for eligibility purposes. Other Exclusions: 6. 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. 7. Participants who use a mobile device that does not meet the minimum requirements of the Electronic diary. 8. Participants who have previously been enrolled in the study cannot be re-enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56 | 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. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Quality Voice Recordings | Day 1 up to Day 56 | 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. |
| Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Day 2 up to Day 43 | 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. |
| Percentage of Participants Who Administered Self-swab 1 and Self-swab 2 | Day 2 up to Day 43 | 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. |
| Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary | Day 2 Up to Day 43 | 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. |
| Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset | Day 2 Up to Day 43 | 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. |
| Percentage of Participants Who Administered Self-swabs With Valid Results | Day 2 Up to Day 43 | 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. |
| Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary | Day 1 up to Day 56 | 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. |
Countries
United States
Participant flow
Recruitment details
This was an observational study involving collection of voice and respiratory symptoms data in participants in both the well state and sick state.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6. | 9,151 |
| Total | 9,151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | No longer met eligibility criteria | 12 |
| Overall Study | Other | 36 |
| Overall Study | Withdrawal by Subject | 553 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 41.03 Years STANDARD_DEVIATION 10.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 793 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7915 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 443 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 116 Participants |
| Race (NIH/OMB) Asian | 89 Participants |
| Race (NIH/OMB) Black or African American | 1127 Participants |
| Race (NIH/OMB) More than one race | 452 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 18 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 237 Participants |
| Race (NIH/OMB) White | 7112 Participants |
| Sex: Female, Male Female | 7235 Participants |
| Sex: Female, Male Male | 1916 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9,151 |
| other Total, other adverse events | 28 / 9,151 |
| serious Total, serious adverse events | 0 / 9,151 |
Outcome results
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Fatigue | 0.259 Scores on a scale | Standard Error 0.0319 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Fever | 0.029 Scores on a scale | Standard Error 0.005 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Headache | 0.194 Scores on a scale | Standard Error 0.0281 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Loss of taste or smell | 0.103 Scores on a scale | Standard Error 0.0266 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Muscle pain | 0.181 Scores on a scale | Standard Error 0.0268 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Rigors | 0.030 Scores on a scale | Standard Error 0.0085 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Sore throat | 0.222 Scores on a scale | Standard Error 0.033 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Stuffy/blocked nose | 0.337 Scores on a scale | Standard Error 0.0443 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Vomiting | 0.005 Scores on a scale | Standard Error 0.0017 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Mean of daily total symptom score | 2.644 Scores on a scale | Standard Error 0.3279 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Chills | 0.065 Scores on a scale | Standard Error 0.011 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Cough | 0.281 Scores on a scale | Standard Error 0.0361 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Diarrhea | 0.036 Scores on a scale | Standard Error 0.0077 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Difficulty breathing | 0.113 Scores on a scale | Standard Error 0.0263 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Nausea | 0.044 Scores on a scale | Standard Error 0.0096 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Runny nose | 0.159 Scores on a scale | Standard Error 0.0216 |
| All Participants | Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 | Wheezing | 0.049 Scores on a scale | Standard Error 0.0174 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 | EE_MFCC mean 01 LSM (10^0), SE (10^-1) | 1.268 Decibel | Standard Error 2.82 |
| All Participants | 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 | EE_MFCC mean 03 LSM (10^-1), SE (10^-1) | 1.390 Decibel | Standard Error 1.262 |
| All Participants | 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 | EE_MFCC mean 04 LSM (10^-1), SE (10^-1) | -1.407 Decibel | Standard Error 1.194 |
| All Participants | 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 | EE_MFCC std 01 LSM (10^-2), SE (10^-2) | 8.365 Decibel | Standard Error 2.873 |
| All Participants | 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 | EE_MFCC std 03 LSM (10^-2), SE (10^-2) | 3.960 Decibel | Standard Error 1.447 |
| All Participants | 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 | EE_MFCC std 04 LSM (10^-2), SE (10^-2) | 2.816 Decibel | Standard Error 1.026 |
| All Participants | 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 | MM_MFCC mean 10 LSM (10^-2), SE (10^-2) | 1.214 Decibel | Standard Error 6.19 |
| All Participants | 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 | READ_MFCC mean 11 LSM (10^-3), SE (10^-2) | 8.703 Decibel | Standard Error 3.665 |
| All Participants | 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 | EE_Cepstral Peak Prominence LSM (10^-3), SE (10^-2) | -1.326 Decibel | Standard Error 1.174 |
| All Participants | 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 | EE_Harmonicity LSM (10^-3), SE (10^-2) | 7.667 Decibel | Standard Error 1.741 |
| All Participants | 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 | EE_MFCC mean 02 LSM (10^-1), SE (10^-1) | -1.752 Decibel | Standard Error 2.127 |
| All Participants | 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 | EE_MFCC mean 05 LSM (10^-3), SE (10^-2) | -4.466 Decibel | Standard Error 8.869 |
| All Participants | 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 | EE_MFCC mean 06 LSM (10^-1), SE (10^-2) | -1.572 Decibel | Standard Error 9.127 |
| All Participants | 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 | EE_MFCC mean 07 LSM (10^-1), SE (10^-2) | 1.248 Decibel | Standard Error 7.598 |
| All Participants | 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 | EE_MFCC mean 08 LSM (10^-1), SE (10^-2) | -1.054 Decibel | Standard Error 7.218 |
| All Participants | 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 | EE_MFCC mean 09 LSM (10^-2), SE (10^-2) | 5.944 Decibel | Standard Error 6.536 |
| All Participants | 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 | EE_MFCC mean 10 LSM (10^-2), SE (10^-2) | -3.115 Decibel | Standard Error 6.007 |
| All Participants | 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 | EE_MFCC std 05 LSM (10^-3), SE (10^-2) | 7.814 Decibel | Standard Error 1.034 |
| All Participants | 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 | EE_MFCC mean 11 LSM (10^-2), SE (10^-2) | -1.908 Decibel | Standard Error 5.932 |
| All Participants | 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 | EE_MFCC mean 12 LSM (10^-4), SE (10^-2) | -6.574 Decibel | Standard Error 5.105 |
| All Participants | 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 | EE_MFCC mean 13 LSM (10^-3), SE (10^-2) | 5.026 Decibel | Standard Error 5.176 |
| All Participants | 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 | EE_MFCC std 02 LSM (10^-2), SE (10^-2) | 2.906 Decibel | Standard Error 1.181 |
| All Participants | 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 | EE_MFCC std 06 LSM (10^-2), SE (10^-3) | 1.151 Decibel | Standard Error 8.443 |
| All Participants | 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 | EE_MFCC std 07 LSM (10^-2), SE (10^-3) | 2.528 Decibel | Standard Error 8.228 |
| All Participants | 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 | EE_MFCC std 11 LSM (10^-2), SE (10^-3) | 1.547 Decibel | Standard Error 6.666 |
| All Participants | 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 | EE_MFCC std 12 LSM (10^-2), SE (10^-3) | 1.118 Decibel | Standard Error 6.122 |
| All Participants | 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 | EE_MFCC std 13 LSM (10^-2), SE (10^-3) | 1.160 Decibel | Standard Error 5.226 |
| All Participants | 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 | EE_MFCC std 08 LSM (10^-2), SE (10^-3) | 1.755 Decibel | Standard Error 7.204 |
| All Participants | 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 | EE_SNR LSM (10^-2), SE (10^-2) | 4.771 Decibel | Standard Error 3.351 |
| All Participants | 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 | MM_MFCC mean 05 LSM (10^-1), SE (10^-2) | -1.265 Decibel | Standard Error 9.67 |
| All Participants | 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 | EE_MFCC std 09 LSM (10^-2), SE (10^-3) | 2.673 Decibel | Standard Error 5.892 |
| All Participants | 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 | EE_MFCC std 10 LSM (10^-2), SE (10^-3) | 1.394 Decibel | Standard Error 5.642 |
| All Participants | 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 | MM_MFCC mean 01 LSM (10^-1), SE (10^-1) | 9.159 Decibel | Standard Error 2.641 |
| All Participants | 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 | MM_MFCC mean 02 LSM (10^-1), SE (10^-1) | -2.180 Decibel | Standard Error 1.894 |
| All Participants | 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 | EE_Shimmer Local dB LSM (10^-4), SE (10^-4) | 8.053 Decibel | Standard Error 9.807 |
| All Participants | 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 | EE_Spectral Flatness LSM (10^-2), SE (10^-2) | -3.945 Decibel | Standard Error 1.892 |
| All Participants | 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 | EE_Third Octave Band LSM (10^-2), SE (10^-2) | -7.075 Decibel | Standard Error 8.409 |
| All Participants | 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 | EE_VLHR LSM (10^-2), SE (10^-2) | 1.658 Decibel | Standard Error 3.607 |
| All Participants | 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 | MM_Cepstral Peak Prominence LSM (10^-2), SE (10^-2) | 1.172 Decibel | Standard Error 1.423 |
| All Participants | 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 | MM_Harmonicity LSM (10^-3), SE (10^-2) | -1.285 Decibel | Standard Error 2.112 |
| All Participants | 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 | MM_MFCC mean 06 LSM (10^-2), SE (10^-2) | 2.851 Decibel | Standard Error 9.96 |
| All Participants | 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 | MM_MFCC mean 07 LSM (10^-1), SE (10^-2) | 1.209 Decibel | Standard Error 7.569 |
| All Participants | 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 | MM_MFCC mean 08 LSM (10^-1), SE (10^-2) | -2.215 Decibel | Standard Error 8.498 |
| All Participants | 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 | MM_MFCC mean 09 LSM (10^-2), SE (10^-2) | 5.560 Decibel | Standard Error 7.072 |
| All Participants | 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 | MM_MFCC mean 11 LSM (10^-1), SE (10^-2) | -1.106 Decibel | Standard Error 4.852 |
| All Participants | 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 | MM_MFCC mean 12 LSM (10^-2), SE (10^-2) | -4.884 Decibel | Standard Error 4.827 |
| All Participants | 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 | MM_MFCC mean 13 LSM (10^-2), SE (10^-2) | 3.600 Decibel | Standard Error 5.634 |
| All Participants | 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 | MM_MFCC std 01 LSM (10^-2), SE (10^-2) | 2.909 Decibel | Standard Error 3.096 |
| All Participants | 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 | MM_MFCC std 02 LSM (10^-2), SE (10^-2) | 1.720 Decibel | Standard Error 2.595 |
| All Participants | 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 | MM_MFCC std 03 LSM (10^-3), SE (10^-2) | 4.403 Decibel | Standard Error 1.503 |
| All Participants | 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 | MM_MFCC std 04 LSM (10^-3), SE (10^-2) | 7.542 Decibel | Standard Error 1.639 |
| All Participants | 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 | MM_MFCC std 05 LSM (10^-2), SE (10^-3) | 2.386 Decibel | Standard Error 8.233 |
| All Participants | 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 | MM_MFCC std 06 LSM (10^-2), SE (10^-2) | 1.593 Decibel | Standard Error 1.243 |
| All Participants | 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 | MM_MFCC std 07 LSM (10^-3), SE (10^-2) | 2.902 Decibel | Standard Error 1.082 |
| All Participants | 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 | MM_MFCC std 08 LSM (10^-2), SE (10^-2) | 1.615 Decibel | Standard Error 1.118 |
| All Participants | 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 | MM_MFCC std 09 LSM (10^-2), SE (10^-2) | 1.116 Decibel | Standard Error 1.104 |
| All Participants | 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 | MM_MFCC std 10 LSM (10^-3), SE (10^-3) | -2.168 Decibel | Standard Error 9.632 |
| All Participants | 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 | MM_MFCC std 11 LSM (10^-2), SE (10^-2) | 1.394 Decibel | Standard Error 1.081 |
| All Participants | 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 | MM_MFCC std 12 LSM (10^-2), SE (10^-3) | 1.375 Decibel | Standard Error 6.622 |
| All Participants | 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 | MM_MFCC std 13 LSM (10^-3), SE (10^-2) | -2.892 Decibel | Standard Error 1.205 |
| All Participants | 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 | MM_SNR LSM (10^-3), SE (10^-2) | -3.105 Decibel | Standard Error 3.256 |
| All Participants | 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 | MM_Shimmer Local dB LSM (10^-4), SE (10^-4) | 6.145 Decibel | Standard Error 9.704 |
| All Participants | 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 | MM_Spectral Flatness LSM (10^-2), SE (10^-2) | -2.911 Decibel | Standard Error 1.969 |
| All Participants | 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 | MM_Third Octave Band LSM (10^-1), SE (10^-2) | -1.487 Decibel | Standard Error 8.77 |
| All Participants | 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 | MM_VLHR LSM (10^-3), SE (10^-2) | 3.089 Decibel | Standard Error 3.396 |
| All Participants | 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 | READ_MFCC mean 01 LSM (10^-1), SE (10^-1) | 8.362 Decibel | Standard Error 2.077 |
| All Participants | 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 | READ_MFCC mean 02 LSM (10^-2), SE (10^-1) | 3.559 Decibel | Standard Error 1.147 |
| All Participants | 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 | READ_MFCC mean 03 LSM (10^-1), SE (10^-2) | 2.043 Decibel | Standard Error 7.752 |
| All Participants | 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 | READ_MFCC mean 04 LSM (10^-2), SE (10^-2) | -8.280 Decibel | Standard Error 6.413 |
| All Participants | 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 | READ_MFCC mean 05 LSM (10^-2), SE (10^-2) | -2.415 Decibel | Standard Error 5.26 |
| All Participants | 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 | READ_MFCC mean 06 LSM (10^-1), SE (10^-2) | -1.209 Decibel | Standard Error 4.904 |
| All Participants | 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 | READ_MFCC mean 07 LSM (10^-2), SE (10^-2) | 2.617 Decibel | Standard Error 4.639 |
| All Participants | 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 | READ_MFCC mean 08 LSM (10^-2), SE (10^-2) | -7.305 Decibel | Standard Error 4.267 |
| All Participants | 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 | READ_MFCC mean 09 LSM (10^-2), SE (10^-2) | -2.369 Decibel | Standard Error 4.428 |
| All Participants | 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 | READ_MFCC mean 10 LSM (10^-2), SE (10^-2) | -7.377 Decibel | Standard Error 3.339 |
| All Participants | 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 | READ_MFCC mean 12 LSM (10^-2), SE (10^-2) | -7.414 Decibel | Standard Error 3.294 |
| All Participants | 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 | READ_MFCC mean 13 LSM (10^-2), SE (10^-2) | 2.929 Decibel | Standard Error 2.705 |
| All Participants | 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 | READ_MFCC std 01 LSM (10^-1), SE (10^-2) | -2.717 Decibel | Standard Error 6.612 |
| All Participants | 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 | READ_MFCC std 02 LSM (10^-2), SE (10^-2) | -5.798 Decibel | Standard Error 2.961 |
| All Participants | 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 | READ_MFCC std 03 LSM (10^-2), SE (10^-2) | -1.008 Decibel | Standard Error 1.778 |
| All Participants | 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 | READ_MFCC std 04 LSM (10^-2), SE (10^-2) | -2.230 Decibel | Standard Error 1.193 |
| All Participants | 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 | READ_MFCC std 05 LSM (10^-2), SE (10^-2) | -1.336 Decibel | Standard Error 1.176 |
| All Participants | 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 | READ_MFCC std 06 LSM (10^-3), SE (10^-2) | -6.497 Decibel | Standard Error 1.413 |
| All Participants | 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 | READ_MFCC std 07 LSM (10^-2), SE (10^-3) | -1.213 Decibel | Standard Error 7.7 |
| All Participants | 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 | READ_MFCC std 08 LSM (10^-3), SE (10^-3) | -7.959 Decibel | Standard Error 9.743 |
| All Participants | 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 | READ_MFCC std 09 LSM (10^-3), SE (10^-3) | -4.137 Decibel | Standard Error 8.017 |
| All Participants | 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 | READ_MFCC std 10 LSM (10^-4), SE (10^-3) | 3.760 Decibel | Standard Error 7.531 |
| All Participants | 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 | READ_MFCC std 11 LSM (10^-3), SE (10^-3) | -2.185 Decibel | Standard Error 5.703 |
| All Participants | 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 | READ_MFCC std 12 LSM (10^-3), SE (10^-3) | 7.716 Decibel | Standard Error 5.746 |
| All Participants | 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 | READ_MFCC std 13 LSM (10^-3), SE (10^-3) | -4.019 Decibel | Standard Error 6.419 |
| All Participants | 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 | READ_SNR LSM (10^-3), SE (10^-2) | 5.103 Decibel | Standard Error 2.737 |
| All Participants | 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 | MM_MFCC mean 03 LSM (10^-1), SE (10^-1) | 1.821 Decibel | Standard Error 1.028 |
| All Participants | 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 | MM_MFCC mean 04 LSM (10^-1), SE (10^-2) | -2.064 Decibel | Standard Error 8.474 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 | EE_MFCC 1st order delta 01 LSM (10^-3), SE (10^-3) | -5.601 Unitless | Standard Error 2.751 |
| All Participants | 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 | EE_Coefficient of Variation F0 LSM (10^-4), SE (10^-4) | 2.975 Unitless | Standard Error 3.383 |
| All Participants | 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 | EE_MFCC 1st order delta 02 LSM (10^-3), SE (10^-3) | 4.120 Unitless | Standard Error 1.464 |
| All Participants | 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 | EE_MFCC 1st order delta 03 LSM (10^-3), SE (10^-3) | -3.067 Unitless | Standard Error 1.053 |
| All Participants | 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 | EE_MFCC 1st order delta 04 LSM (10^-3), SE (10^-4) | 2.780 Unitless | Standard Error 9.751 |
| All Participants | 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 | EE_MFCC 1st order delta 05 LSM (10^-3), SE (10^-4) | -1.324 Unitless | Standard Error 8.289 |
| All Participants | 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 | EE_MFCC 1st order delta 06 LSM (10^-4), SE (10^-4) | -2.606 Unitless | Standard Error 9.707 |
| All Participants | 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 | EE_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4) | -5.071 Unitless | Standard Error 7.593 |
| All Participants | 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 | EE_MFCC 1st order delta 08 LSM (10^-4), SE (10^-4) | 3.067 Unitless | Standard Error 6.273 |
| All Participants | 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 | EE_MFCC 1st order delta 09 LSM (10^-3), SE (10^-4) | -1.649 Unitless | Standard Error 7.998 |
| All Participants | 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 | EE_MFCC 1st order delta 10 LSM (10^-4), SE (10^-4) | 8.236 Unitless | Standard Error 7.053 |
| All Participants | 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 | EE_MFCC 1st order delta 11 LSM (10^-4), SE (10^-4) | -2.920 Unitless | Standard Error 6.839 |
| All Participants | 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 | EE_MFCC 1st order delta 12 LSM (10^-4), SE (10^-4) | -3.363 Unitless | Standard Error 6.312 |
| All Participants | 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 | EE_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4) | 7.281 Unitless | Standard Error 5.677 |
| All Participants | 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 | EE_MFCC 2nd order delta 01 LSM (10^-4), SE (10^-3) | 5.153 Unitless | Standard Error 1.523 |
| All Participants | 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 | EE_MFCC 2nd order delta 02 LSM (10^-3), SE (10^-4) | -1.330 Unitless | Standard Error 6.782 |
| All Participants | 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 | EE_MFCC 2nd order delta 03 LSM (10^-4), SE (10^-4) | -1.560 Unitless | Standard Error 6.763 |
| All Participants | 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 | EE_MFCC 2nd order delta 04 LSM (10^-5), SE (10^-4) | -9.713 Unitless | Standard Error 6.18 |
| All Participants | 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 | EE_MFCC 2nd order delta 05 LSM (10^-4), SE (10^-4) | 4.520 Unitless | Standard Error 5.576 |
| All Participants | 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 | EE_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4) | -1.528 Unitless | Standard Error 5.586 |
| All Participants | 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 | EE_MFCC 2nd order delta 07 LSM (10^-5), SE (10^-4) | -5.254 Unitless | Standard Error 4.217 |
| All Participants | 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 | EE_MFCC 2nd order delta 08 LSM (10^-4), SE (10^-4) | -4.591 Unitless | Standard Error 3.83 |
| All Participants | 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 | EE_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4) | 7.046 Unitless | Standard Error 3.687 |
| All Participants | 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 | EE_MFCC 2nd order delta 10 LSM (10^-4), SE (10^-4) | -1.564 Unitless | Standard Error 3.606 |
| All Participants | 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 | EE_MFCC 2nd order delta 11 LSM (10^-5), SE (10^-4) | 6.573 Unitless | Standard Error 2.81 |
| All Participants | 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 | EE_MFCC 2nd order delta 12 LSM (10^-4), SE (10^-4) | -4.071 Unitless | Standard Error 3.664 |
| All Participants | 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 | EE_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-4) | 2.799 Unitless | Standard Error 3.317 |
| All Participants | 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 | MM_Coefficient of Variation F0 LSM (10^-4), SE (10^-4) | 1.123 Unitless | Standard Error 1.676 |
| All Participants | 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 | MM_MFCC 1st order delta 01 LSM (10^-5), SE (10^-3) | 7.586 Unitless | Standard Error 2.882 |
| All Participants | 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 | MM_MFCC 1st order delta 02 LSM (10^-4), SE (10^-3) | 8.249 Unitless | Standard Error 1.815 |
| All Participants | 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 | MM_MFCC 1st order delta 03 LSM (10^-3), SE (10^-3) | -1.188 Unitless | Standard Error 1.322 |
| All Participants | 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 | MM_MFCC 1st order delta 04 LSM (10^-4), SE (10^-3) | -7.258 Unitless | Standard Error 1.101 |
| All Participants | 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 | MM_MFCC 1st order delta 05 LSM (10^-3), SE (10^-4) | -1.326 Unitless | Standard Error 7.555 |
| All Participants | 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 | MM_MFCC 1st order delta 06 LSM (10^-4), SE (10^-3) | 5.502 Unitless | Standard Error 1.056 |
| All Participants | 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 | MM_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4) | -4.691 Unitless | Standard Error 7.305 |
| All Participants | 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 | MM_MFCC 1st order delta 08 LSM (10^-3), SE (10^-4) | -1.530 Unitless | Standard Error 7.82 |
| All Participants | 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 | MM_MFCC 1st order delta 09 LSM (10^-4), SE (10^-4) | 4.166 Unitless | Standard Error 7.294 |
| All Participants | 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 | MM_MFCC 1st order delta 10 LSM (10^-3), SE (10^-4) | -2.112 Unitless | Standard Error 7.299 |
| All Participants | 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 | MM_MFCC 1st order delta 11 LSM (10^-4), SE (10^-4) | -7.706 Unitless | Standard Error 7.494 |
| All Participants | 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 | MM_MFCC 1st order delta 12 LSM (10^-4), SE (10^-4) | 2.388 Unitless | Standard Error 6.494 |
| All Participants | 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 | MM_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4) | 2.121 Unitless | Standard Error 6.877 |
| All Participants | 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 | MM_MFCC 2nd order delta 01 LSM (10^-3), SE (10^-3) | -2.784 Unitless | Standard Error 1.667 |
| All Participants | 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 | MM_MFCC 2nd order delta 02 LSM (10^-4), SE (10^-4) | -1.368 Unitless | Standard Error 9.117 |
| All Participants | 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 | MM_MFCC 2nd order delta 03 LSM (10^-3), SE (10^-4) | -1.551 Unitless | Standard Error 6.294 |
| All Participants | 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 | MM_MFCC 2nd order delta 04 LSM (10^-3), SE (10^-4) | 1.840 Unitless | Standard Error 7.343 |
| All Participants | 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 | MM_MFCC 2nd order delta 05 LSM (10^-3), SE (10^-4) | 1.290 Unitless | Standard Error 5.029 |
| All Participants | 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 | MM_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4) | -1.473 Unitless | Standard Error 5.891 |
| All Participants | 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 | MM_MFCC 2nd order delta 07 LSM (10^-4), SE (10^-4) | -5.556 Unitless | Standard Error 4.647 |
| All Participants | 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 | MM_MFCC 2nd order delta 08 LSM (10^-3), SE (10^-4) | 1.128 Unitless | Standard Error 5.339 |
| All Participants | 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 | MM_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4) | -3.297 Unitless | Standard Error 5.134 |
| All Participants | 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 | MM_MFCC 2nd order delta 10 LSM (10^-4), SE (10^-4) | -2.104 Unitless | Standard Error 3.528 |
| All Participants | 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 | MM_MFCC 2nd order delta 11 LSM (10^-4), SE (10^-4) | 5.126 Unitless | Standard Error 4.289 |
| All Participants | 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 | MM_MFCC 2nd order delta 12 LSM (10^-4), SE (10^-4) | 2.703 Unitless | Standard Error 4.094 |
| All Participants | 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 | MM_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-4) | -2.020 Unitless | Standard Error 5.334 |
| All Participants | 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 | READ_MFCC 1st order delta 01 LSM (10^-3), SE (10^-4) | -2.660 Unitless | Standard Error 9.22 |
| All Participants | 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 | READ_MFCC 1st order delta 02 LSM (10^-4), SE (10^-4) | 6.490 Unitless | Standard Error 4.448 |
| All Participants | 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 | READ_MFCC 1st order delta 03 LSM (10^-4), SE (10^-4) | 1.355 Unitless | Standard Error 3.323 |
| All Participants | 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 | READ_MFCC 1st order delta 04 LSM (10^-5), SE (10^-4) | 7.664 Unitless | Standard Error 2.574 |
| All Participants | 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 | READ_MFCC 1st order delta 05 LSM (10^-4), SE (10^-4) | -1.708 Unitless | Standard Error 2.028 |
| All Participants | 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 | READ_MFCC 1st order delta 06 LSM (10^-4), SE (10^-4) | 2.510 Unitless | Standard Error 1.904 |
| All Participants | 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 | READ_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4) | 2.393 Unitless | Standard Error 1.627 |
| All Participants | 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 | READ_MFCC 1st order delta 08 LSM (10^-4), SE (10^-4) | 4.111 Unitless | Standard Error 1.553 |
| All Participants | 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 | READ_MFCC 1st order delta 09 LSM (10^-5), SE (10^-4) | -4.151 Unitless | Standard Error 1.134 |
| All Participants | 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 | READ_MFCC 1st order delta 10 LSM (10^-4), SE (10^-4) | 1.593 Unitless | Standard Error 1.291 |
| All Participants | 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 | READ_MFCC 1st order delta 11 LSM (10^-4), SE (10^-5) | 1.893 Unitless | Standard Error 9.442 |
| All Participants | 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 | READ_MFCC 1st order delta 12 LSM (10^-4), SE (10^-5) | 1.380 Unitless | Standard Error 6.614 |
| All Participants | 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 | READ_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4) | 1.166 Unitless | Standard Error 1.04 |
| All Participants | 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 | READ_MFCC 2nd order delta 01 LSM (10^-3), SE (10^-4) | -1.190 Unitless | Standard Error 5.79 |
| All Participants | 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 | READ_MFCC 2nd order delta 02 LSM (10^-4), SE (10^-4) | -4.504 Unitless | Standard Error 3.04 |
| All Participants | 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 | READ_MFCC 2nd order delta 03 LSM (10^-4), SE (10^-4) | 2.968 Unitless | Standard Error 3.334 |
| All Participants | 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 | READ_MFCC 2nd order delta 04 LSM (10^-5), SE (10^-4) | -7.963 Unitless | Standard Error 2.101 |
| All Participants | 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 | READ_MFCC 2nd order delta 05 LSM (10^-4), SE (10^-4) | 5.075 Unitless | Standard Error 1.878 |
| All Participants | 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 | READ_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4) | -1.880 Unitless | Standard Error 1.174 |
| All Participants | 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 | READ_MFCC 2nd order delta 07 LSM (10^-4), SE (10^-4) | 1.667 Unitless | Standard Error 1.164 |
| All Participants | 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 | READ_MFCC 2nd order delta 08 LSM (10^-4), SE (10^-5) | 1.531 Unitless | Standard Error 9.552 |
| All Participants | 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 | READ_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4) | 1.989 Unitless | Standard Error 1.076 |
| All Participants | 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 | READ_MFCC 2nd order delta 10 LSM (10^-5), SE (10^-5) | 5.573 Unitless | Standard Error 9.318 |
| All Participants | 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 | READ_MFCC 2nd order delta 11 LSM (10^-5), SE (10^-5) | 1.774 Unitless | Standard Error 8.677 |
| All Participants | 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 | READ_MFCC 2nd order delta 12 LSM (10^-5), SE (10^-5) | 7.327 Unitless | Standard Error 6.63 |
| All Participants | 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 | READ_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-5) | 1.534 Unitless | Standard Error 9.067 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 | AHH_Max Phonation Time: LSM (10^-1), SE (10^-2) | -1.519 Seconds | Standard Error 2.769 |
| All Participants | 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 | EE_Jitter Local Absolute: LSM (10^-8) | 6.899 Seconds | Standard Error 0 |
| All Participants | 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 | MM_Jitter Local Absolute: LSM (10^-7) | -1.743 Seconds | Standard Error 0 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56 | EE_Entropy: LSM (10^-3), SE (10^-3) | -1.931 Bit | Standard Error 3.554 |
| All Participants | Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56 | MM_Entropy: LSM (10^-4), SE (10^-3) | -1.479 Bit | Standard Error 2.847 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56 | EE_Jitter Local: LSM (10^-4), SE (10^-3) | 8.654 Percentage of period | Standard Error 1.441 |
| All Participants | Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56 | MM_Jitter Local: LSM (10^-4), SE (10^-3) | -2.206 Percentage of period | Standard Error 3.176 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56 | EE_Shimmer Local: LSM (10^-3), SE (10^-2) | 7.567 Percentage of amplitude | Standard Error 1.12 |
| All Participants | Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56 | MM_Shimmer Local: LSM (10^-3), SE (10^-2) | 6.060 Percentage of amplitude | Standard Error 1.101 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56 | EE_Voiced Frames: LSM (10^-4), SE (10^-3) | -4.024 Frame per second | Standard Error 3.122 |
| All Participants | Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56 | MM_Voiced Frames: LSM (10^-4), SE (10^-4) | -6.624 Frame per second | Standard Error 7.961 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 1: LSM (10^-2), SE (10^-1) | -3.262 Hertz | Standard Error 4.487 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 1 Bandwidth: LSM (10^-2), SE (10^-1) | -6.912 Hertz | Standard Error 5.997 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 2: LSM (10^-1), SE (10^0) | 1.985 Hertz | Standard Error 1.23 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 2 Bandwidth: LSM (10^-1), SE (10^0) | 6.573 Hertz | Standard Error 2.191 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 3: LSM (10^-1), SE (10^-1) | 6.504 Hertz | Standard Error 8.958 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | EE_Formant 3 Bandwidth: LSM (10^-2), SE (10^0) | 9.459 Hertz | Standard Error 1.255 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 1: LSM (10^-1), SE (10^-1) | 6.945 Hertz | Standard Error 7.972 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 1 Bandwidth: LSM (10^-2), SE (10^0) | 2.424 Hertz | Standard Error 1.021 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 2: LSM (10^-1), SE (10^0) | -9.256 Hertz | Standard Error 1.083 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 2 Bandwidth: LSM (10^-1), SE (10^0) | 9.350 Hertz | Standard Error 1.289 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 3: LSM (10^0), SE (10^0) | 2.105 Hertz | Standard Error 1.231 |
| All Participants | Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 | MM_Formant 3 Bandwidth: LSM (10^0), SE (10^0) | 1.664 Hertz | Standard Error 1.358 |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56 | 2.130 Syllable per second | Standard Error 3.211 |
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.
Time frame: Day 2 Up to Day 43
Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants had administered self swab 2 and were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary | 18.98 Days | Standard Deviation 17.01 |
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.
Time frame: Day 1 up to Day 56
Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary | Symptom Compliance | 33.81 Percentage of days | Standard Deviation 35.158 |
| All Participants | Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary | Voice Compliance | 32.06 Percentage of days | Standard Deviation 34.535 |
| All Participants | Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary | Partial Voice Compliance | 0.49 Percentage of days | Standard Deviation 1.369 |
| All Participants | Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary | Symptom and Voice Compliance | 32.06 Percentage of days | Standard Deviation 34.535 |
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.
Time frame: Day 2 Up to Day 43
Population: Full analysis set included all participants who signed the informed consent document and enrolled in 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset | Par who adm SS2 before W6/par who reported new or inc symptoms in e-diary before W6 | 9.3 Percentage of participants |
| All Participants | Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset | Par who reported new or inc sym in e-diary before W6/par who adm SS2 before W6 | 22.3 Percentage of participants |
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.
Time frame: Day 2 up to Day 43
Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Administered Self-swab 1 and Self-swab 2 | Participants who administered self-swab 1 | 43.4 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swab 1 and Self-swab 2 | Participants who administered self-swab 2 | 31.4 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swab 1 and Self-swab 2 | Participants who administered self-swab 1 and self-swab 2 | 28.3 Percentage of participants |
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.
Time frame: Day 2 Up to Day 43
Population: Full analysis set included all participants who signed the informed consent document and enrolled in 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 1 result for SARS-CoV-2 | 91.24 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 1 result for Flu A | 91.21 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 1 result for Flu B | 91.21 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 1 result for RSV | 91.21 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 2 result for SARS-CoV-2 | 93.57 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 2 result for Flu A | 93.57 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 2 result for Flu B | 93.57 Percentage of participants |
| All Participants | Percentage of Participants Who Administered Self-swabs With Valid Results | Positive or negative self-swab 2 result for RSV | 93.57 Percentage of participants |
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.
Time frame: Day 2 up to Day 43
Population: Full analysis set included all participants who signed the informed consent document and enrolled in 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 1: SARS-COV-2 | 6 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 1: Flu A | 0.2 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 1: Flu B | 0 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 1: RSV | 0.1 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 1: SARS-CoV-2 and/or Influenza and/or RSV | 6.3 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 2: SARS-COV-2 | 7.7 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 2: Flu A | 0.2 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 2: Flu B | 0 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 2: RSV | 0.6 Percentage of participants |
| All Participants | Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV | Self-swab 2: SARS-CoV-2 and/or Influenza and/or RSV | 8.5 Percentage of participants |
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.
Time frame: Day 1 up to Day 56
Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Percentage of Quality Voice Recordings | 84.15 Percentage of quality recordings | Standard Deviation 20.23 |