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Registry Tracking Long-Term Covid-19 Impacts

Data pointing finger

(Vitaly Vlasov, Pexels)

15 Jan. 2021. A study now underway is tracking long-term effects of Covid-19 infections using real-world data from electronic sources provided by patients. The Innovative Support for Patients with SARS-CoV-2 Infections Registry, or Inspire trial is conducted by eight academic medical centers in the U.S., led by Rush University in Chicago.

The Inspire clinical trial is a patient registry that seeks to learn effects of Covid-19 on people in the 18 months following their diagnosis of infection. The study is enrolling 3,600 individuals with Covid-19 infections and displaying symptoms of the disease. For comparison, the trial is also recruiting another 1,200 participants reporting symptoms similar to those infected, but testing negative for Covid-19. U.S. Centers for Disease Control and Prevention is funding the project.

Among participants, the study team is looking primarily for signs of myalgic encephalomyelitis, or chronic fatigue syndrome, a long-term disease causing fatigue, malaise, sleep interruptions, difficulty concentrating, and dizziness. The researchers are also tracking several other indicators including need for hospitalization, outpatient care, survival time without visiting a hospital or intensive-care unit, and death.

“This disease will be with us for years to come,” says Rush University chief analytics officer Bala Hota, also the study’s principle investigator, in a university statement, “and understanding the impact on the health of survivors will be essential to our understanding of how to treat it. This work will provide the foundation for our long-term understanding of the ongoing impact of Covid-19.”

In addition to Rush University Medical Center, participants are currently being enrolled at University of Washington in Seattle and Yale University in New Haven, Connecticut. Enrollment is expected to begin later at University of Texas Health in Houston, University of California in Los Angeles and San Francisco, University of Texas Southwestern in Dallas, and Thomas Jefferson University in Philadelphia.

Data gleaned from existing health records

Data for the trial are collected through a system called Hugo that compiles real-world data with permission of participants. Real-world data are collected routinely for other business or health purposes, such as from electronic health records, insurance claims, fitness trackers, smart watches, or other mobile apps. They also include data provided from surveys completed by participants.

Participants are expected to complete surveys every three months over the 18-month period, with each survey taking no more than 30 minutes. All data are collected remotely, with no travel required to the medical centers. Participants are also compensated up to $100 for taking part.

Having this wealth of data in electronic form is expected to provide rapid analytics for researchers, to better understand patient outcomes almost as they occur. The researchers say they also plan to engage participants more as partners in the study, rather than statistical data points, to find ways of maximizing value of participants’ information while maintiaing their privacy.

In May 2020, as reported by Science & Enterprise, the Food and Drug Administration began collecting and evaluating real-world evidence from electronic health records and other sources to better understand the Covid-19 patient population, symptoms they express, medications taken, and risk factors for complications. The analytics are expected to help FDA better evaluate proposed diagnostics, vaccines, and treatments.

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