Long Covid Patients Can Join Remote Trial Notification by CareEvolution
At-home participation in a study by Scripps Research and Schmidt Initiative for Long Covid powered by CareEvolution’s MyDataHelps® platform
Long Covid patients around the U.S. looking to participate in a clinical trial from home can sign up to be notified when an upcoming study conducted by scientists at Scripps Research and supported by the Schmidt Initiative for Long Covid (SILC) opens. Patients can sign up on the Long Covid Treatment Trial (LoCITT) website.
The upcoming study, powered by the MyDataHelps platform from CareEvolution, is a fully remote clinical trial investigating the efficacy of a repurposed drug for treating Long COVID. It will enroll 1,000 Long Covid patients from across the U.S. The app-based study enables participants to enroll and participate in all trial activities without having to visit a trial clinic.
“Decentralized trials broaden reach, speed timelines and yield richer real-world evidence,” said Vik Kheterpal, MD, a principal at CareEvolution. “LoCITT will help advance how efficiently we can run trials as we seek treatments for complex, heterogeneous conditions like Long Covid.”
Long Covid, which has affected the lives of 400 million people worldwide and costs the global economy an estimated $1 trillion per year, can often cause symptoms that make mobility and travel challenging for patients who want to participate in trials. The forthcoming Scripps Research-led trial will rely on the LoCITT platform to enroll patients, distribute drug candidates and placebos, as well as collect and evaluate trial data.
“For people with severe Long Covid, travel can be dangerous,” said Julia Moore Vogel, senior program director at the Scripps Research Translational Institute. “LoCITT enables even patients with the most severe symptoms to join the search for answers.” Moore Vogel is co-principal investigator of the study alongside Scripps Research executive vice president Eric Topol.
Remote trials, which eliminate the need for patients to report to clinics, enable easier and broader participation. Conducting a Long Covid trial remotely will also allow more representative cohorts—potentially leading to more generalizable findings.
“We need aggressive, rapid efforts to turn the tide on this very difficult condition for all the patients who struggle with it,” said John Redd, CEO of SILC. “We’re hopeful that a remote trial will help us find effective treatments more quickly.”
CareEvolution adapted its existing MyDataHelps decentralized clinical trial platform specifically for the LoCITT trial, with the potential for it to be used by other research efforts. The platform will allow for patients to be screened, enrolled and randomized more swiftly. Potential treatments and placebos will be mailed directly to the participant’s home, along with wearable devices and other technologies to collect patient data.
CareEvolution’s user-friendly platform allows patients to check their eligibility, provide consent electronically and respond to baseline and ongoing surveys about their symptoms. Patients selected for the study will receive wrist devices to monitor their heart rates, activity and sleep, potentially enabling the development of digital biomarkers for Long Covid and related conditions like myalgic encephalomyelitis (ME), which can cause debilitating fatigue, and postural orthostatic tachycardia syndrome (POTS), which can cause dizziness, fatigue and a rapid heart rate upon standing up. The data from the devices will be uploaded to LoCITT.
Prospective participants who are 18 years of age or older and who believe they have Long Covid can sign up at longcovid.scripps.edu to be notified when the Scripps clinical trial opens.
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