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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR


Participation Criteria
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Eligibility Criteria
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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: 4. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br> | Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR<br>* nasal swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2, influenza virus or RSV positive participants. | Obtain data to characterize the relationship between symptoms and voice features for 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. | Day 1 to follow up (Week 6-8) | 
| Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2, influenza virus or RSV positive participants. | Obtain data to characterize the relationship between symptoms and voice features for 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. | Day 1 to follow-up (Week6-8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of total days of voice recordings entered in the Electronic diary. | Assess compliance of the participants using the Electronic diary to collect data. | Day 1 to follow-up (Week 6-8) | 
| Percentage of total days of symptoms entered in the Electronic diary. | Assess compliance of the participants using the Electronic diary to collect data. | Day 1 to follow-up (Week6-8) | 
| Percentage of recordings with signal to noise ratio ≥ 20 dB that have duration ≥ 3 sec for phoneme and ≥ 10 sec for reading tasks. | Test the quality of the recording from the Electronic diary to collect data that is usable for interpretation. | Day 1 to follow-up (Week 6-8) | 
| Percentage of participants with SARS-CoV-2; and/or Influenza; and/or RSV RT-PCR based positivity in self-swabs. | Determine rates of positivity for SARS-CoV-2/Influenza/RSV infection. | Day 1 to follow-up (Week 6-8) | 
| Percentage of participants administering the self-swab at self-swab #1 and self-swab #2. | Evaluate the feasibility of obtaining self-swabs. | Day 1 to follow-up (Week 6-8) | 
| Percentage of participants reporting symptoms in the Electronic diary, who have a self-swab collected at or around symptom onset. | Evaluate the feasibility of obtaining self-swabs. | Day 1 to follow-up (Week 6-8) | 
| Percentage of self-swabs with valid (positive or negative) or invalid (non- reportable due to technical or self-collection failures) results. | Evaluate the feasibility of obtaining self-swabs. | Day 1 to follow-up (Week 6-8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Covid 19, Coronavirus, SARS-CoV-2, Flu, Influenza, RSV, Respiratory syncytial virus, Respiratory illness, Acute respiratory illness, remote trial, voice, AcRIS