News Category: Press Release
Scripps Research scientists launch new digital clinical trial to test repurposed drug for long COVID symptom relief
Study will investigate whether a GIP/GLP-1 dual receptor agonist, currently approved for type 2 diabetes, obesity and obstructive sleep apnea, can reduce symptoms of long COVID.
FOR IMMEDIATE RELEASE
Oct. 30, 2025
Contact:
press@scripps.edu
LA JOLLA, Calif.—Scientists at the Scripps Research Translational Institute invite people with long COVID across the U.S. to join a remote clinical trial that is testing whether an existing FDA-approved therapy, tirzepatide, can provide relief from long COVID symptoms.
The Long COVID Treatment Trial (LoCITT, pronounced ‘lock-it’) is a novel research platform funded by the Schmidt Initiative for Long Covid (SILC) as part of its grant to support the tirzepatide trial. LoCITT is dedicated to accelerating discoveries for the complex, multisystem condition which has affected the lives of more than 400 million people worldwide. There are currently no FDA-approved drugs for the treatment of long COVID.
Tirzepatide, a GIP/GLP-1 dual receptor agonist, is currently approved for type 2 diabetes, overweight and obesity, and obstructive sleep apnea. The initial trial will explore whether the drug’s anti-inflammatory effects can improve symptoms in people with long COVID.
LoCITT’s remote clinical trial technology will allow for swift screening, enrollment and randomization of patients. Drugs and placebos will be mailed directly to the participant’s home, and participants will also use wearable devices and smart scales so scientists can track real-time health changes and measure the drug’s impact on symptoms.
“We’re seeing GLP-1 drugs show tremendous promise across a wide range of conditions, including improving markers of body-wide and brain inflammation, which is common in long COVID,” says Eric Topol, executive vice president of Scripps Research and co-principal investigator of LoCITT. “Given the urgency of finding an effective treatment for long COVID, it’s critical that we test the most promising agent—tirzepatide is at the top of our list.”
Long COVID is marked by a wide range of symptoms that develop and continue months and even years after an acute COVID-19 infection. It can affect multiple organ systems, including respiratory, cardiovascular, neurological, musculoskeletal and immunological, with the constellation of more than 200 possible symptoms varying from person to person and commonly including debilitating fatigue. How long COVID presents in patients—and the lack of a biomarker to effectively detect it—adds to the difficulty in diagnosing and treating the condition.
“Drug repurposing represents the fastest potential path to treatment for long COVID,” says John Redd, CEO of SILC. “Combining that with safety monitoring, at-home clinical trial participation makes this a particularly promising trial and a model for future studies of complex diseases.”
Scripps Research scientists seek to enroll 1,000 trial participants from across the U.S. in a fully remote, randomized control trial to study the effect of tirzepatide on long COVID over the course of one year. Participants will use the MyDataHelps app to check their eligibility, provide consent, complete surveys, order research materials and receive compensation for participating in the study. Participants will be randomized into an intervention arm of individuals who will receive tirzepatide or a control arm of those who will receive a placebo. All participants will also receive a Garmin fitness tracker and smart scale so physiological data can be shared, and both devices may be kept after the study is complete. Fifty participants will be selected as part of an at-home blood sampling cohort for exploratory biomarker analysis and clinical testing. The LoCITT study team will be available to answer questions and provide support via email, phone and video visits.
“There is an urgent need for validated treatments for long COVID,” says Julia Moore Vogel, co-principal investigator of LoCITT. “For many individuals who are housebound or bedbound, traveling to a clinic is harmful or impossible, which is why we have designed this study to be accessible from home. Our approach seeks to lower barriers for participation in recognition of the meaningful contributions people with long COVID make through their time and energy.”
LoCITT is open to individuals 18 years of age or older, who live in the U.S., have medical documentation of long COVID and meet other inclusion criteria. The platform will be used to test additional interventions in the near future. For more details regarding LoCITT, including how to participate in this or subsequent trials, please visit https://longcovid.scripps.edu/.
The study team will host a webinar on November 5, 2025, 11 a.m. PT/2 p.m. ET to provide an overview of the trial and participant journey. Registration is required.
In addition to Scripps Research and SILC, LoCITT collaborator organizations include CareEvolution, Adachi-Odai Solutions, Garmin, YourBio Health, Infinity Bio Inc. and Olink. Eli Lilly and Company is providing the study medicine.
Scripps Research performs scientific investigation and drug discovery only. We cannot provide medical advice.
About Scripps Research
Scripps Research is an independent, nonprofit biomedical research institute ranked one of the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr-Skaggs, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 U.S. programs for chemistry and biological sciences. Learn more at www.scripps.edu.
About the Schmidt Initiative for Long Covid
The Schmidt Initiative for Long Covid (SILC) advances clinical care for Long Covid patients globally. The nonprofit organization, founded in 2023 by philanthropists Eric and Wendy Schmidt, works to raise the level of Long Covid care and understanding around the world, connecting specialists and primary care providers to support patients and share knowledge virtually, in real time. For more information, visit silc.org.
Long Covid patients can sign up for remote clinical trial notification
FOR IMMEDIATE RELEASE
July 29, 2025
Contact:
CareEvolution
pr@careevolution.com
Swati Pandey, SILC
spandey@silc.org
Anna Andersen, Scripps Research
aanders@scripps.edu
ANN ARBOR, Mich.—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.
About CareEvolution
We Connect Healthcare. MyDataHelps®, our digital clinical trials platform, accelerates healthcare innovation by empowering researchers to configure and launch studies in hours. We enable anyone, anywhere to be able to participate in research using participant centric design that integrates surveys, wearable and sensor data, EHR connectivity, and participant engagement tools to generate robust real-world longitudinal data. Trusted by over 2.5 million participants enrolled in longitudinal initiatives sponsored by health systems, academic institutions, life science companies, foundations, and public health agencies, CareEvolution advances precision health and helps close critical gaps in our collective understanding of complex conditions. For more information please visit careevolution.com.
About the Schmidt Initiative for Long Covid
The Schmidt Initiative for Long Covid (SILC) advances clinical care for Long Covid patients globally. The nonprofit organization, founded in 2023 by philanthropists Eric and Wendy Schmidt, works to raise the level of Long Covid care and understanding around the world, connecting specialists and primary care providers to support patients and share knowledge virtually, in real time. For more information, visit https://silc.org/.
About Scripps Research
Scripps Research is an independent, nonprofit biomedical institute ranked one of the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr-Skaggs, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 US programs for chemistry and biological sciences. Learn more at www.scripps.edu.
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Clinical trial underway for potential Long Covid treatment
Nova Southeastern University and the Schmidt Initiative for Long Covid will study the efficacy of a long-acting antibody for treating Long Covid
FOR IMMEDIATE RELEASE
May 1, 2025
Contact:
Swati Pandey, SILC spandey@silc.org
Kyle Fisher, Nova Southeastern University kfisher@nova.edu
FORT LAUDERDALE, Fla. — A clinical trial is underway to assess the effectiveness and safety of sipavibart, AstraZeneca’s long-acting monoclonal antibody designed to provide protection against Covid-19, as a potential treatment for Long Covid, the Nova Southeastern University (NSU) and the Schmidt Initiative for Long Covid (SILC) announced today.
With funding from SILC, NSU researchers led by Dr. Nancy Klimas are enrolling 100 patients in the multi-year study with the goal of improving their Long Covid symptoms and restoring them to full health.
“Like many multi-symptom, post-viral conditions, Long Covid is incredibly complicated and thus little understood,” said Klimas, director of the Institute for Neuro-lmmune Medicine at NSU. “Finding a treatment will be life-changing for patients suffering from the myriad symptoms of Long Covid.”
The study will test whether the monoclonal antibody sipavibart, which is approved for the pre-exposure prophylaxis (prevention) of Covid-19 in Japan and the EU, is effective in treating Long Covid. The trial, which the FDA reviewed and cleared for the study earlier this year, is one of three Long Covid treatment trials expected to begin in 2025 that have been initiated and funded by SILC, a nonprofit organization founded in 2023 by philanthropists Eric and Wendy Schmidt to advance Long Covid care for patients globally.
“Long Covid affects at least 65 million people worldwide, and with more than 200 symptoms, the health impacts of the disease can be debilitating,” said Dr. John Redd, CEO of SILC. “SILC is dedicated to eliminating Long Covid worldwide, especially in under-resourced countries and communities, by bringing together practitioners to treat patients and by funding research such as monoclonal antibodies and repurposing existing drugs.”
Said Dr. Ken Dawson-Scully, NSU’s senior vice president for research and associate provost, “This trial represents our overall commitment to addressing the most pressing health challenges of our time. By collaborating with the Schmidt Initiative for Long Covid, we’re leveraging our research expertise to potentially transform treatment options for millions suffering from Long Covid, advance knowledge, and improve patient outcomes through innovative clinical research.”
At the height of the pandemic, Florida was the national leader in utilizing monoclonal antibodies to treat patients who had been diagnosed with Covid, administering more than 200,000 doses throughout the state. In 2024, researchers from the state published a study in the American Journal of Emergency Medicine detailing how a small group of these patients’ Long Covid symptoms disappeared after they received the monoclonal antibodies to prevent or treat acute episodes of the virus. When Redd—who was a leader of the U.S. Department of Health and Human Services’ response to the virus and helped distribute the antibody therapeutics to Florida years earlier—came across the study, he contacted the authors to organize a collaboration, leading to this trial.
In the double-blind, randomized and controlled trial, researchers will divide patients into two evenly split groups to receive infusions of either a placebo or sipavibart, which targets the unique spike proteins of the Covid virus. Patients will be evaluated every three months for improvement in Long Covid symptoms including cognitive dysfunction—lapses in attention, concentration or reaction time—heart rate or blood pressure dysregulation and other autonomic nervous system effects, and tolerance for exercise. Researchers will also test for any lingering spike proteins in patients, including potentially in plasma and stool samples, and create a repository of blood and other specimens for further study.
NSU, Florida’s largest private research university, is an R1 institution—an elite designation given by the Carnegie Foundation to universities reaching the highest levels of research activity, funding, and doctoral degrees awarded.
Visit Research Studies | NSU Institute for Neuro-Immune Medicine for information on participating in this study.
Photo: Dr. Nancy Klimas
Photo credit: Cory Galiszewski
About Nova Southeastern University
Nova Southeastern University (NSU) is a top employer in the state, with more than $5 billion in projected economic impact. NSU is classified as an R1 institution by the Carnegie Foundation among universities with the highest level of research activity, funding and doctoral degrees awarded. NSU educates more than 22,000 enrolled students from more than 115 countries and all 50 U.S. states. NSU is a Military Friendly School, committed to meeting the needs of its active military and veteran population. It is 1 of 3 universities in the U.S. with both M.D. and D.O. colleges and is the largest educator of physicians in Florida. Research at NSU addresses such critical areas as cancer, marine life, and brain health. Visit www.nova.edu for more information. View Fast Facts here.
About the Schmidt Initiative for Long Covid
The Schmidt Initiative for Long Covid (SILC) advances clinical care for Long Covid patients globally. The nonprofit organization, founded in 2023 by philanthropists Eric and Wendy Schmidt, works to raise the level of Long Covid care and understanding around the world, connecting specialists and primary care providers to support patients and share knowledge virtually, in real time. For more information, visit https://silc.org/.
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Global clinical trial to test existing drugs as Long Covid treatments
Western University and Schmidt Initiative for Long Covid will enroll more than 300 patients across four continents
FOR IMMEDIATE RELEASE
April 24, 2025
Contact: Swati Pandey, SILC
spandey@silc.org
Contact: Cynthia Fazio, Western University
cynthia.fazio@uwo.ca
LONDON, ONTARIO, CANADA — Spanning four continents and enrolling hundreds of people, a new clinical trial will test the effectiveness of two anti-inflammatory medicines as potential treatments for long COVID, scientists from Western University and the Schmidt Initiative for Long Covid (SILC) announced today.
“Despite the global prevalence of long COVID, patients report different symptoms and their presentation can be influenced by where they happen to live,” said Dr. Douglas D. Fraser, professor at Western University’s Schulich School of Medicine & Dentistry. “A study with global reach, tailored to examine each patient’s most severe symptoms, has the potential to bring hope to people well beyond Canada and the U.S.”
The trial, funded by SILC, will examine whether upadacitinib and pirfenidone—approved for treating arthritis and lung disease, respectively–-can be repurposed to reduce or eliminate symptoms of long COVID. The drugs were identified by an earlier SILC-funded study that, over the past 18 months, examined over 5,400 blood proteins from 1,028 participants with and without long COVID and found 13 common biological pathways for the progression of the disease. Upadacitinib and pirfenidone were identified using artificial intelligence as two existing drugs that could interrupt several of those pathways.
“Drug repurposing has the potential to bring effective treatments to long COVID patients worldwide far more quickly than creating a new medicine from scratch,” said Dr. John Redd, CEO of SILC. “Our hope is that the 65 million people living each day with this often debilitating condition will soon find relief for their symptoms—no matter where in the world they happen to live.”
Spanning seven trial locations in the U.S., Canada, Brazil, Italy, Uganda and Zambia, the Phase III, double-blind, placebo-controlled multi-arm platform study will enroll a total of 348 participants. Researchers will track five symptoms—fatigue, breathing issues, memory and thinking problems, muscle and joint aches and circulation—to determine which is most severe in each patient. Researchers will investigate the two drugs versus placebos for the first three months, perform an analysis, and then monitor participants for an additional three months.
The study will progress using an adaptive platform—meaning researchers can pivot to stop testing either of the drugs if they fail to show results or, if both drugs appear promising, stop use of the placebo. The method was notably used to rapidly develop and test COVID therapeutics during Operation Warp Speed.
The trial is the second of three set for the first half of this year with funding and guidance from SILC, a nonprofit organization founded in 2023 by philanthropists Eric and Wendy Schmidt to advance long COVID care for patients globally.
For more information about the study, visit ClinicalTrials.gov and search the identifier NCT06928272.
Photo: Dr. Douglas D. Fraser
Photo credit: Rena Panchyshyn, special to Western Communications
About Western University
Western University delivers an academic experience second to none. Since 1878, The Western Experience has combined academic excellence with life-long opportunities for intellectual, social and cultural growth in order to better serve our communities. Our research excellence expands knowledge and drives discovery with real-world application. Western attracts individuals with a broad worldview, seeking to study, influence and lead in the international community. For more information, visit https://uwo.ca/.
About the Schmidt Initiative for Long Covid
The Schmidt Initiative for Long Covid (SILC) advances clinical care for Long Covid patients globally. The nonprofit organization, founded in 2023 by philanthropists Eric and Wendy Schmidt, works to raise the level of Long Covid care and understanding around the world, connecting specialists and primary care providers to support patients and share knowledge virtually, in real time. For more information, visit https://silc.org/.
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