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

CompletedN/A

Sponsor: Pfizer

Conditions: Healthy

Interventions: SARS-CoV-2/Influenza/RSV RT-PCR

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.

Locations (1)

New Orleans, Louisiana, United States