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ACTIV-2 will evaluate the safety and efficacy of investigational treatments for adults who have COVID-19, but do not require hospitalization. ACTIV-2 is a randomized, blinded, controlled study that tests a variety of new agents against placebo. This approach allows promising investigational agents to be added and removed over the course of the study.
“This study aims to identify a treatment that can prevent people with COVID-19 from developing advanced disease that requires hospitalization,” said Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at UH. “UH is at the forefront of testing experimental treatments for COVID-19, including remdesivir, stem cell therapy and convalescent plasma. Patients suffering from complications of COVID-19 have hope at UH thanks to these options.”
The study, which is one of the few outpatient COVID-19 treatment trials in the Greater Cleveland area, will be conducted at UH Cleveland Medical Center in collaboration with Case Western Reserve University (CWRU) School of Medicine. Jeffrey Jacobson, MD, attending physician in the Division of Infectious Diseases and HIV Medicine, UH Cleveland Medical Center, and Professor of Medicine at CWRU School of Medicine will serve as the principal investigator. Additionally, Leila Hojat, MD, attending physician in the division of Infectious Diseases and HIV Medicine, UH Cleveland Medical Center, and Assistant Professor of Medicine at CWRU School of Medicine will serve as co-investigator.
The first investigational agent to be evaluated by ACTIV-2 is an experimental monoclonal antibody treatment known as LY-CoV555, developed by Eli Lilly and Company. Lilly scientists rapidly developed the antibody after it was discovered by AbCellera and scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from a patient in the United States who recovered from COVID-19. People’s bodies make antibodies to fight infections. Monoclonal antibodies are produced in a lab. These antibodies seem able to attack the COVID-19 virus and prevent it from getting into cells. LY-CoV555 is given as an infusion into a vein in the arm.
ACTIV-2 is sponsored by NIAID, part of the National Institutes of Health (NIH), and conducted by the NIAID-funded AIDS Clinical Trials Group. ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It is also receiving support from Operation Warp Speed, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
“The need for effective treatments is critical in the fight against COVID-19. While people with the disease may start off with just a few minor symptoms, they can rapidly become very ill,” said Dr. Jacobson. “People living in Northeast Ohio who have recently been diagnosed with COVID-19 and are not hospitalized have the opportunity to make a huge contribution by participating in this study.”
“There is significant concern nationally as to how hospitals will handle the burden of both influenza and COVID-19 this winter,” said Mukesh K. Jain, MD, Chief Academic Officer at UH. “Studies focused on helping people recover from COVID-19 at home, without needing hospitalization, are vitally important and we hope our engagement in the ACTIV-2 trial will help us achieve this goal for our community.”
To qualify for the study, participants must have tested positive for SARS-CoV-2 infection in the outpatient setting within seven days and started experiencing symptoms within 10 days of enrolling into the study. At least half of participants will have factors that put them at high risk for progressing to severe COVID-19, including being age 55 or older and having one of the following conditions: chronic lung, kidney, or liver disease; obesity; hypertension; cardiovascular disease; diabetes; or moderate to severe asthma. UH and NIAID have prioritized making study participation in the trial available to those who are often underrepresented in clinical research.
For information about enrolling in the trial at University Hospitals:
Call: 1-833-78-TRIAL
Email: [email protected]
Visit: uhhospitals.org/researchvolunteer
For more information about ACTIV-2, please visit the study website.
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About University Hospitals
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 50 health centers and outpatient facilities, and 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship academic medical center, University Hospitals Cleveland Medical Center, located in Cleveland’s University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children’s Hospital, ranked among the top children’s hospitals in the nation; University Hospitals MacDonald Women’s Hospital, Ohio’s only hospital for women; University Hospitals Harrington Heart & Vascular Institute, a high-volume national referral center for complex cardiovascular procedures; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women’s health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals – part of The Harrington Project for Discovery & Development. UH is one of the largest employers in Northeast Ohio with 28,000 physicians and employees. Advancing the Science of Health and the Art of Compassion is UH’s vision for benefitting its patients into the future, and the organization’s unwavering mission is To Heal. To Teach. To Discover. Follow UH on LinkedIn, Facebook @UniversityHospitals and Twitter @UHhospitals. For more information, visit UHhospitals.org.
