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

NCT04748445

Last updated date

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Participants are excluded from the study if any of the following criteria apply:


Medical Conditions:


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.


2. Prior/Concomitant Therapy: Participants who have been vaccinated with COVID-19 vaccine
or are planning to get vaccinated during the 8 weeks of the study. Participants can
continue to use all other prescription or non-prescription medications.


Prior/Concurrent Clinical Study Experience:


3. 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:


4. Screening diagnostic assessments are not required for eligibility purposes.


Other Exclusions:


5. 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.


6. Participants who use a mobile device that does not meet the minimum requirements of
the Electronic diary.


-

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title 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.
Brief Summary

The purpose of the AcRIS study is to obtain data to build a voice and symptom algorithm(s) for detection and monitoring of SARS-CoV-2 illness and characterize the relationship of symptoms and voice features for SARS-CoV-2 positive participants. Secondarily, data will further characterize self-reported voice and symptom profiles for acute respiratory illnesses in participants; this would benefit vaccine development across several key disease areas, including RSV and influenza virus, beyond the immediate application to SARS-CoV-2.

The study also models concepts of more efficient "flexible" clinical trials involving not only voice recognition, 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 and SARS-CoV-2 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 respiratory illness including SARS-CoV-2 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
SARS-CoV-2/Influenza/RSV RT-PCR
Sampling Method Non-Probability Sample
Study Population Planned enrollment of approximately 6,250 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 (swab #2) symptomatic completers.
Condition Healthy
Intervention Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR
nasal swab
Study Groups/Cohorts All participants
Intervention: Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 5, 2021)
6250
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2021
Estimated Primary Completion Date October 15, 2021   (Final data collection date for primary outcome measure)
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:

Medical Conditions:

  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.
  2. Prior/Concomitant Therapy: Participants who have been vaccinated with COVID-19 vaccine or are planning to get vaccinated during the 8 weeks of the study. Participants can continue to use all other prescription or non-prescription medications.

    Prior/Concurrent Clinical Study Experience:

  3. 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:

  4. Screening diagnostic assessments are not required for eligibility purposes.

    Other Exclusions:

  5. 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.
  6. Participants who use a mobile device that does not meet the minimum requirements of the Electronic diary.

    -

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04748445
Other Study ID Numbers X9001293
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021