The University of Illinois Chicago will conduct three clinical trials for studying blood clot prevention in patients with COVID-19.
Blood clots are one of the leading complications of COVID-19. Patients with COVID-19 often form blood clots throughout their bodies, which, if untreated, can lead to organ damage, including stroke, pulmonary embolism and heart attacks. We need to stop blood clot formation in order to prevent these potentially fatal complications of COVID-19 infection."
Dr. Jerry Krishnan, UIC associate vice chancellor for population health sciences
The three clinical trials will study the safety and effectiveness of various types of blood thinners to treat adults diagnosed with COVID-19. The trials are part of the antithrombotics arm of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, initiative. All three clinical trials, collectively known as the ACTIV-4 antithrombotics studies, are coordinated and overseen by the National Heart, Lung, and Blood Institute and are funded through Operation Warp Speed.
UIC is the only institution in Chicago that served on the NIH's Protocol Development Committees for these national clinical trials.
"Through these trials, we want to find out the best way to use approved blood clot treatments and prevention strategies for patients with COVID-19," said Krishnan, who also is UIC professor of medicine at the College of Medicine, professor of public health at the School of Public Health and executive director at the Institute for Healthcare Delivery Design.
Two of the three trials have launched at UIC.
The ACTIV-4 Outpatient study at UIC, which began enrolling patients Oct. 21, is investigating whether anticoagulants or other antithrombotic therapies can reduce life-threatening cardiovascular or pulmonary complications in newly diagnosed COVID-19 patients who do not require admission to the hospital, or those who are "outpatients."
Participants in the study will be enrolled when they visit UI Health, UIC's health system.
At UIC, Dr. Janet Lin is the principal investigator for the outpatient study.
"This is an opportunity for us to determine the best medications and medical advice to provide to COVID-19 patients who visit our clinics or the emergency department. Patients will be randomly assigned to receive one of three treatments or a placebo comparator, and we will follow these patients to see if one group has better outcomes," said Lin, UIC professor of emergency medicine at the College of Medicine.
Participants who enroll in the outpatient trial are assigned to take either a placebo, aspirin, low-dose apixaban or a treatment-dose of apixaban. Researchers also will collect patient data and blood samples to help identify new drug targets and biomarkers that may determine a patient's risk of developing thrombotic complications related to COVID-19.
The ACTIV-4 Inpatient study at UIC, which began enrolling patients Oct. 30, is investigating the safety and effectiveness of using varying doses of blood thinners such as heparin or enoxaparin to prevent clotting events and improve outcomes in COVID-19 patients hospitalized at UI Health, or those that are "inpatients."
Patients in the inpatient trial are assigned to receive either low or high doses of a blood thinner, and as the trial progresses, additional antithrombotic medications may be tested. All participants in the study continue to receive standard clinical care, as indicated, for their condition.
Dr. John Quigley is the principal investigator for the inpatient trial at UIC.
"Patients who are hospitalized with COVID-19 are very vulnerable. Our job as physicians is to use emerging clinical and scientific evidence to inform our bedside decisions. By understanding which treatments work best to prevent blood clots in hospitalized COVID-19 patients, we can better personalize their care and, hopefully, prevent life-threatening complications to improve their outcomes," said Quigley, UIC associate professor of hematology/oncology at the College of Medicine.
A third trial is anticipated to launch later this month.
The study -- called the ACTIV-4 Post-Discharge study -- will investigate treatments to help prevent blood clots after a patient is discharged from the hospital. Quigley also will serve as the UIC principal investigator of this trial.
"We have quickly recognized that the effects of COVID-19 often last well beyond the initial illness," Quigley said. "Following these COVID-19 patients after hospital discharge and learning how to prevent further complications after the acute illness is an important part of ensuring that people can get back to their normal activities and remain healthy."
In addition, UIC was awarded $8.5 million by the NIH to serve as the national Research Communication Center, or RCC, for two of the three clinical trials -- the outpatient and post-discharge studies.
The RCC will serve as the critical point of contact for the thousands of study participants from around the nation enrolled in these two studies and their health care providers. The RCC will respond to questions, collect safety and effectiveness outcomes data, and track progress of study participants with the help of call center agents and UI Health clinical pharmacists and physicians.
"The RCC is a vital part of the ACTIV-4 studies. It is a collaborative effort between UIC, the University of Pittsburgh and Duke University, which serves as a foundation for ensuring the data from these studies are reliable," said Krishnan, who serves as the principal investigator for the RCC.
At UIC, the RCC represents a collaboration between the College of Medicine, College of Pharmacy and the Institute of Healthcare Delivery Design.
UIC also was awarded $3.4 million to serve as an Illinois Clinical Coordinating Center for other sites in Illinois to participate as clinical enrollment sites for the ACTIV-4 Outpatient study.
The UIC research team working with the principal investigators includes Dr. Jeff Jacobson, Neha Atal, Nina Bracken, Laura Carrera, Lauren Castro, Gabrielle Cavaliere, Colleen Clark, Julie DeLisa, Sharon Hasek, Erika Hellenbart, Nina Huynh, Sai Illendula, Keri Kim, Ann Kutcha, James Lee, Cindy Leman, Miriam Martinez, Conny Mei, Brandi Morlen, Jennifer Peterson, Erin Pozzolano, Barbara Predki, Jennifer Sculley, Nancy Shapiro, Jissell Torres and Ellen Uppuluri.
The NIH announced the ACTIV public-private partnership in April 2020 to develop a coordinated national research response to accelerate COVID-19 treatment and vaccine options. As part of this partnership, Bristol-Myers Squibb and Pfizer have agreed to donate antithrombotic treatments for the ACTIV-4 Outpatient and Post-Discharge studies.