Clinical trial NCT04748445: Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.
Official title: Acute Respiratory Illness Surveillance (ARIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Covid-19
Covid 19
Coronavirus
SARS-CoV-2
Flu
Influenza
RSV
Respiratory syncytial virus
Respiratory illness
Acute respiratory illness
remote trial
voice
AcRIS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 9151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned enrollment of approximately 8700 participants 18 years of age or older in order to have a total of N of 100 participants with (1) confirmed negative SARS-CoV-2, RSV or Influenza RT-PCR (swab #1) and (2) confirmed positive SARS-CoV-2 RT-PCR, influenza virus or RSV (swab #2) symptomatic completers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: 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
timeFrame: Baseline up to Day 56
measure: 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
timeFrame: Baseline up to Day 56
measure: 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
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
measure: Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56
timeFrame: Baseline up to Day 56
Secondary outcomes:
measure: Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
timeFrame: Day 1 up to Day 56
measure: Percentage of Quality Voice Recordings
timeFrame: Day 1 up to Day 56
measure: Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
timeFrame: Day 2 up to Day 43
measure: Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
timeFrame: Day 2 up to Day 43
measure: Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary
timeFrame: Day 2 Up to Day 43
measure: Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset
timeFrame: Day 2 Up to Day 43
measure: Percentage of Participants Who Administered Self-swabs With Valid Results
timeFrame: Day 2 Up to Day 43
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: