N/A
N=9,151
Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04748445 ↗Enrolled (actual)
9,151
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 — 0.065; 0.281; 0.036; 0.113 Scores on a scale — p=<.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SARS-CoV-2/Influenza/RSV RT-PCR (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56 |
0.065; 0.281; 0.036; 0.113; 0.259; 0.029 | <.0001 sig |
| PRIMARY 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 |
-1.519; 6.899; -1.743 | <.0001 sig |
| PRIMARY 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 |
-1.326; 7.667; 1.268; -1.752; 1.390; -1.407 | 0.9103 |
| PRIMARY 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 |
2.975; -5.601; 4.120; -3.067; 2.780; -1.324 | 0.3809 |
| PRIMARY Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56 |
-1.931; -1.479 | 0.5878 |
| PRIMARY Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56 |
-3.262; -6.912; 1.985; 6.573; 6.504; 9.459 | 0.9421 |
| PRIMARY Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56 |
-4.024; -6.624 | 0.8977 |
| PRIMARY Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56 |
8.654; -2.206 | 0.5491 |
| PRIMARY Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56 |
7.567; 6.060 | 0.5004 |
| PRIMARY Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56 |
2.130 | <.0001 sig |
| SECONDARY Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary |
33.81; 32.06; 0.49; 32.06 | — |
| SECONDARY Percentage of Quality Voice Recordings |
84.15 | — |
| SECONDARY Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV |
6; 0.2; 0; 0.1; 6.3; 7.7 | — |
| SECONDARY Percentage of Participants Who Administered Self-swab 1 and Self-swab 2 |
43.4; 31.4; 28.3 | — |
| SECONDARY Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary |
18.98 | — |
| SECONDARY Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset |
9.3; 22.3 | — |
| SECONDARY Percentage of Participants Who Administered Self-swabs With Valid Results |
91.24; 91.21; 91.21; 91.21; 93.57; 93.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
- Male or female participants ≥18 years of age (or the minimum state specific age of consent if >18), at Screening visit.
Type of Participant and Disease Characteristics:
- Participants who are willing and able to comply with daily symptom and voice assessments on the electronic diary application and other study procedures, including self-collection of nasal swabs.
- Expected to be available for the duration of the study.
Informed Consent:
- Capable of giving signed informed consent
-
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
- Participants who self-report any medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent, or in the investigator's judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
- Participants who have been vaccinated with COVID-19 vaccine or are planning to get vaccinated during study participation.
Participants can continue to use all other prescription or non-prescription medications.
Prior/Concurrent Clinical Study Experience:
- Previous vaccination with any licensed or investigational RSV vaccine or are planning to get vaccinated during study participation.
- Previous administration with an investigational drug within 30 days of enrollment (or as determined by the local requirement) or planning to participate in an interventional trial during study conduct.
Diagnostic Assessments:
- Screening diagnostic assessments are not required for eligibility purposes.
Other Exclusions:
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator including vendors, and their respective family members.
- Participants who use a mobile device that does not meet the minimum requirements of the Electronic diary.
- Participants who have previously been enrolled in the study cannot be re-enrolled.
Data sourced from ClinicalTrials.gov (NCT04748445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.