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

Launched by PFIZER · Feb 5, 2021

Keywords

ClinConnect Summary

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 stud...

Gender

ALL

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.