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

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ClinicalTrials.gov Identifier: NCT04748445
Recruitment Status : Active, not recruiting
First Posted : February 10, 2021
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment
Healthy Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR

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.

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Study Type : Observational
Estimated Enrollment : 6250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Respiratory Illness Surveillance (ARIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study.
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : November 23, 2021
Estimated Study Completion Date : November 23, 2021

Group/Cohort Intervention/treatment
All participants Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR
nasal swab




Primary Outcome Measures :
  1. Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2 positive participants. [ Time Frame: Day 1 to follow up (Week 6-8) ]
    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.

  2. Change in voice features; such as pitch, jitter, harmonicity, entropy, flatness, shimmer from the voice collection as captured by the Electronic diary from well to sick in symptomatic SARS-CoV-2 positive participants. [ Time Frame: Day 1 to follow-up (Week6-8) ]
    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.


Secondary Outcome Measures :
  1. Percentage of total days of voice recordings entered in the Electronic diary. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Assess compliance of the participants using the Electronic diary to collect data.

  2. Percentage of total days of symptoms entered in the Electronic diary. [ Time Frame: Day 1 to follow-up (Week6-8) ]
    Assess compliance of the participants using the Electronic diary to collect data.

  3. Percentage of recordings with signal to noise ratio ≥ 20 dB that have duration ≥ 3 sec for phoneme and ≥ 10 sec for reading tasks. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Test the quality of the recording from the Electronic diary to collect data that is usable for interpretation.

  4. Percentage of participants with SARS-CoV-2; and/or Influenza; and/or RSV RT-PCR based positivity in self-swabs. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Determine rates of positivity for SARS-CoV-2/Influenza/RSV infection.

  5. Percentage of participants administering the self-swab at self-swab #1 and self-swab #2. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Evaluate the feasibility of obtaining self-swabs.

  6. Percentage of participants reporting symptoms in the Electronic diary, who have a self-swab collected at or around symptom onset. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Evaluate the feasibility of obtaining self-swabs.

  7. Percentage of self-swabs with valid (positive or negative) or invalid (non- reportable due to technical or self-collection failures) results. [ Time Frame: Day 1 to follow-up (Week 6-8) ]
    Evaluate the feasibility of obtaining self-swabs.


Biospecimen Retention:   Samples Without DNA
SARS-CoV-2/Influenza/RSV RT-PCR


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748445


Locations
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United States, Louisiana
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04748445    
Other Study ID Numbers: X9001293
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: August 2021
Individual Participant Data (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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Covid-19
Covid 19
Coronavirus
SARS-CoV-2
Flu
Influenza
RSV
Respiratory syncytial virus
Respiratory illness
Acute respiratory illness
remote trial
voice
AcRIS