Illinois Medicine

for outpatient and discharge studies. The National Heart, Lung and Blood Institute and Operation Warp Speed are providing an estimated $10 million to $15 million for all three clinical trials, Illi-Net, and the Research Communication Center. "Like the vaccine trials, we are deliberately trying to enroll patients who represent the diversity of America," says Krishnan. "UIC affords a unique opportu- nity to complete studies relevant to under- represented minority populations because we serve that community." Understanding the outcomes of COVID-19 LASTLY, KRISHNAN IS ALSO LEAD- ING Predictors of Severe COVID-19 Outcomes (PRESCO), a $2.5 million study funded by the Sergey Brin Family Founda- tion, led by Google co-founder Sergey Brin, and sponsored by Verily. The PRESCO study focuses on building models which predict the risk that COVID-19 patients who come to the hospital will develop acute respiratory distress and/or mortality, and then prioritizing high-risk individuals for earlier and more aggressive intervention. "As the first site in the country to be awarded the research contract for PRESCO, UIC was able to drive the sci- ence for the study," Krishnan explains. "We are bringing together investigators across UIC to collect and examine biologi- cal specimens to see how the viral genome will change over time." The goal is to enroll 1,500 patients across the country in 10 clinical centers, with results expected in the second half of 2021. Hope on the horizon WHILE THERE ARE STILL MANY HURDLES to overcome in conquering COVID-19, progress is being made. The research efforts of UIC scientists and oth- ers around the country provide hope as they unravel the mysteries of preventing and treating the disease. Around the world, people eagerly await a vaccine to stem the tide of the pandemic. With research proving the safety and efficacy of one of the first vaccine candidates in this epidemiological "moon shot," Illinois Medicine has played a key role in making sure that "the Eagle has landed." adds. UIC received $166,805 to collaborate in a global study as part of a public-private partnership with the manufacturer, Regen- eron, and BARDA; in the end, the study found that sarilumab did not work. "Since hospitals were looking to find any drug that would help, this study helped stop the ineffective practice of using sarilumab to treat COVID-19," Krishnan says. "Clinical trials help us to determine not only what works, but what doesn't. That's equally as important." Monoclonal antibodies: Another prevention tool IN ADDITION TO ITS WORK ON VACCINE DEVELOPMENT, UIC is investigating the use of a "cocktail" of monoclonal antibodies as a preventive tool to help stop the spread of COVID-19. Compared with natural antibodies, which take weeks to be produced upon infection or vaccination, a lab-made cocktail of monoclonal antibodies can be produced more quickly ahead of time and engineered to be more potent. These also can be used to provide instantaneous protection, thus saving precious time. Funded with $567,750 by Regeneron Pharmaceuticals and fully enrolled with 25 participants, the trial tested whether the cocktail or the monoclonal antibodies against SARS-CoV-2 were effective in protecting uninfected individuals from getting sick after someone in their household tests positive for COVID-19. The end result: it was 100% effective. Volunteers were required to be asymptomatic and enroll within four days of their housemate testing positive. Nationally, 2,000 people are expected to enroll in this randomized, double-blind, placebo-controlled study, which involves four injections. Results are expected in the near future. "If we are able to show that the mono- clonal antibody cocktail is effective in preventing other household members from getting sick, that would have a huge impact on decreasing the spread of COVID-19," says Jesica Herrick, MD, associate profes- sor of infectious diseases and principal investigator. Antithrombotics: Preventing complications BEYOND INITIAL INFECTION, clini- cal trials are also testing the longer-term effects of COVID-19. Blood clots are one of the disease's leading complications, leading to organ damage, including stroke, pulmonary embolism and heart attacks. As part of the ACTIV initiative, three clinical trials were launched in late 2020 to study how safe and effective different blood thinners are for COVID-19 outpa- tients, inpatients and those who have been discharged from the hospital. "As the only institution in Chicago to serve on all three protocol committees for these national clinical trials, we helped design the studies," says Krishnan. The outpatient study is led at UI Health by Janet Lin, MD, MPH, MBA, professor of emergency medicine and director of health systems development at the Center for Global Health. The trial will test a placebo, aspirin or a low or therapeutic dose of the blood thinner apixaban in 7,000 outpatients nationally. The goal is to see if anticoagulants or other antithrombotics will reduce cardiovascu- lar or pulmonary complications in newly diagnosed COVID-19 patients. A study of 2,000 inpatients nation- ally will receive varying dosages of a blood thinner, either heparin or lovenox, to prevent clotting events. The inpatient clinical trial is led at UIC by John Quigley, MD, associate professor of hematology and oncology. A third clinical trial will investigate anticoagulants and/or antiplatelet treat- ments to prevent blood clots after a patient is discharged from the hospital. Also led by Quigley, the trial will assess if patients develop these complications within 45 days of being hospitalized for moderate or severe COVID-19. Finally, Lin, Quigley and Keri Kim, PharmD, a clinical pharmacist and assis- tant professor in the College of Pharmacy, have created "Illi-Net," a network of hos- pitals across Illinois that also will recruit COVID-19 patients for these ACTIV anti-thrombotic studies. In addition, UIC will serve as the national Research Communication Center for the outpatient and post-discharge stud- ies in a collaborative effort between UIC, the University of Pittsburgh and Duke University. That center "will collect in- formation on all patients enrolled in these studies nationally to help us identify the benefits and harms of these therapies," says Krishnan, who is the principal investigator 16 | Spring 2021

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