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NCT04748445 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Pfizer.

Completed
Registry status
9,151
Enrollment target

NCT04748445: Completed study, sponsored by Pfizer.

NCT04748445 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 9,151 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04748445 has completed, sponsored by Pfizer.

COMPLETED
Registry status
9,151 participants
Enrollment target

Study Summary

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.

Primary Outcome

Symptoms (fever, cough, difficult breathing, fatigue, runny nose, stuffy/blocked nose, sore throat, loss of taste/smell, chills, muscle pain, diarrhea, vomiting, headache, nausea, rigors, wheezing) recorded at least once daily in e-diary for 8 weeks \& rated 0:none to 4:severe for fever \& 0:none to 7:severe for other symptoms. Total symptom score=sum of all symptom scores in a recording session \& mean of daily total symptom score=average across available sessions for each day, range=0 to 109,

Interventions

  • DIAGNOSTIC_TEST SARS-CoV-2/Influenza/RSV RT-PCR

Trial Details

FieldValue
Enrollment Target 9,151 participants
Start Date 2021-04-12
Est. Completion 2022-04-22
Pfizer

1,845 total trials

What the finished NCT04748445 record still lists

NCT04748445 is an observational study that tracks outcomes without assigning an intervention. Its 9,151 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which SARS-CoV-2/Influenza/RSV RT-PCR is the first listed.

NCT04748445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04748445 about?

NCT04748445 is a clinical study titled "Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.". 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 ...

What is the current status of trial NCT04748445?

This trial is currently completed. The enrollment target is 9,151 participants. The study started on 2021-04-12. Estimated completion is 2022-04-22.

What interventions are being tested in trial NCT04748445?

The interventions under investigation include: SARS-CoV-2/Influenza/RSV RT-PCR (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04748445?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04748445, the US trial registry maintained by the National Library of Medicine. NCT04748445 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.