Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate.
Ochsner Health to Enroll Participants in Pfizer Voice Recognition Study
New Study Format Leverages Technology to Explore Relationship Between Voice and Acute Respiratory Symptoms
NEW ORLEANS, La. – Ochsner Health announced its participation as the only site in the United States for the Acute Respiratory Illness Surveillance (AcRIS) by Monitoring with Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study, sponsored by Pfizer Inc. The study is seeking to enroll healthy adult volunteers ages 18 and above who have not yet received a COVID-19 vaccine and do not plan to receive one during the six- to eight-week study. The study will enroll up to 6,250 participants from across the United States.
The Ochsner site team is led by Principal Investigator Leonardo Seoane, MD (Ochsner Health Senior Vice President and Chief Academic Officer); W. Mark Roberts, MD, MMM (Ochsner Health Dean of Research); Edmond Kabagambe, DVM, PhD, MBA (Ochsner Health AVP of Outcomes Research); and David Houghton (Ochsner Health System Chair of Telemedicine), AcRIS is a decentralized study leveraging web-based participant recruitment, remote electronic consent, and symptom and sample collection via a secure mobile application that is downloaded onto a participant’s cell phone.
The AcRIS study will collect participant data to attempt to build a voice and symptom algorithm(s) for the potential detection and monitoring of SARS-CoV-2, the virus that causes COVID-19, as well as other respiratory diseases. Beyond the immediate application of such an algorithm to COVID-19, analyzing the relationships between acute respiratory symptoms and voice features in this study could lead to the development of an algorithm or tool to detect and monitor other viral respiratory diseases, including influenza and respiratory syncytial virus (RSV).
“By digitizing the study participant journey, we hope to eliminate barriers for trial participation and recruitment, ultimately creating a more equitable platform for participants to contribute to research and clinical studies that is not limited by geographical barriers. Ochsner Health has a rich history of developing and leveraging technology aimed at helping patients manage chronic conditions, such as diabetes and hypertension. It is a natural evolution to team up with Pfizer to model how technology can play a key role in reimagining how researchers approach a study, potentially forging a new path for the next generation of clinical studies, including interventional trials,” said Dr. Seoane.
This new study format models the concept of a more efficient, “flexible” clinical trial, which utilizes technology to enhance participant engagement by removing many of the common barriers to participating in a clinical study – proximity to study site, transportation issues, lack of time required for in person enrollment, and check-in appointments. Pending findings, this study could serve as a model for future interventional studies where participation is not dependent on location.
“This study is important not only for its potential application to the ongoing COVID-19 pandemic but for the scientific community to better understand how voice features can correlate with respiratory illnesses. Furthermore, these technologies may change how we approach vaccine trials in the future," said Robert Joe Mather, Executive Director, Early Clinical Development, at Pfizer. "It is another exciting step in making studies more decentralized, which we believe may help remove barriers to participation in certain clinical trials and ultimately speed the delivery of breakthroughs that change patients' lives."
How the AcRIS Study Works
All eligible participants who consent to join the study will be enrolled and followed virtually for six and up to eight-weeks. During the study, participants are asked to complete a daily recording of symptoms and brief three to four-second voice features using a mobile application (AcRIS) on their cell phones. Two kits for self-collection of nasal swabs are mailed to participants, one for use at baseline and the other for use either when participants become ill or reach week six of the study without developing symptoms. The self-collected samples are used to perform a polymerase chain reaction (PCR) test to detect the presence of COVID-19, influenza and RSV and results are returned to participants within 48 hours of test-result availability for the individual to share with their healthcare provider.
Participants must be 18 years or older at the time of enrollment, have a smartphone, and must not have received a COVID-19 vaccine or plan to receive one during the six- to eight-week study. Due to the decentralized nature of the study, participants will not have direct face-to-face interactions with the study staff, further ensuring confidentiality and study access by participants from varied geographic areas in the United States. The study is actively enrolling, and interested participants are encouraged to learn more or enroll through the study website.
Ochsner remains committed to playing a vital role in searching for a solution to build immunity against COVID-19 and has participated in more than 30 COVID-19 clinical trials, including the Pfizer vaccine trial for adults and adolescents ages 12-17.
Individuals interested in participating in COVID-19 research opportunities at Ochsner are encouraged to email COVIDVaccine@ochsner.org. To learn more about Ochsner’s COVID-19 response, please visit www.ochsner.org/coronavirus.
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About Ochsner Health
Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate. Ochsner Health is a not-for-profit committed to giving back to the communities it serves through preventative screenings, health and wellness resources and partnerships with innovative organizations that share our vision. Ochsner Health healed more than 900,000 people from across the globe in 2020, providing the latest medical breakthroughs and therapies, including digital medicine for chronic conditions and telehealth specialty services. Ochsner Health is a national leader, named both the top hospital and the top children’s hospital in Louisiana by U.S. News & World Report. As Louisiana’s leading healthcare educator, Ochsner Health and its partners educate thousands of healthcare professionals annually. Ochsner Health is innovating healthcare by investing in new technologies and research to make world-class care more accessible, affordable, convenient and effective. Ochsner's team of more than 32,000 employees and 4,500 providers are working to reinvent the future of health and wellness in the region. To learn more about Ochsner Health, please visit www.ochsner.org. To transform your health, please visit www.ochsner.org/healthyyou.
