Over the summer, the University of Utah concluded a study indicating that COVID-19 influenced change in blood platelets may spur heart attacks, strokes, and other serious cardiovascular complications. Now Intermountain Healthcare, one of the nation’s leading healthcare systems, is supporting a major clinical trial involving 7,000 COVID-19 patients, sponsored by the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to investigate the connection of blood clots to COVID-19 patients. They study team hopes to actually prevent blood clots and risky illness associated with individuals who contracted COVID-19.
Recently, University of Utah research revealed that when people get infected by COVID-19 that changes in blood platelets triggered by COVID-19 may directly provoke onset of heart attacks, strokes, and other serious complications in at least some patients infected by the pathogen. As it turns out, the disease is associated with inflammatory proteins produced during infection, purportedly making the platelets “hyperactive” and consequently prone to form dangerous and potentially deadly blood clots.
Sarah Majercik, MD, and trauma surgeon at Intermountain Health, serves as primary investigator for the study. Dr. Majercik shared recently on a local media KUTV that COVID-19 is associated with an increase in the development of blood clots not only in the heart but also lungs and even legs. Researchers here in Utah suspect that this novel coronavirus possibly leads to microthrombi, that is tiny clots, at least in some patients.
Dr. Majercik continued, “These are tiny clots that we can’t detect by traditional imaging methods but when in the lungs they may cause patients who at first seem stable to get much sicker quickly, have breathing difficulties and potentially need a ventilator.”
Study Falls Under NIH ACTIV Program
Sponsored by the National Heart, Lung and Blood Institute, a part of the National Institutes of Health (NIH) in conjunction with Operation Warp Speed, Intermountain Health is actually one of three primary trial sites that now evaluate whether common medications can stop blood clots associated with COVID-19.
This study is actually part of what is known as the ACTIV4b program, part of the National Institute of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines or ACTIV.
The study falls under the “ACTIV-4 master protocol,” which was designed by the federal research agency to assess the safety and effectiveness of various blood thinners for treating adults diagnosed with COVID-19. At present, the government-sponsored program includes three adaptive platform clinical trials targeting the treatment of COVID-19 associated blood coagulopathy (CAC) or clotting, including 1) inpatient, 2) outpatient, and 3) convalescent.
This four arm study, described in more detail below, calls for the use of safe and effective and common medications used to prevent and treat blood clots in millions of patients daily. Those study subjects who qualify for this study will be given one of four types and doses of medication that include the following:
· 81 mg of aspirin (once a day low dose aspirin)
· 2.5 mg of apixaban twice per day
· 5mg of apixaban taken twice per day
Patients will follow there study arm regimen for 45 days and for a period of 75 days investigators will check in with them weekly, monitoring for blood clots, etc.
This present study (NCT04498273) conducted here in Utah fits into the outpatient category and focuses on whether anticoagulants or antithrombotic therapy can reduce life-threatening cardiovascular or pulmonary complications in newly diagnosed COVID-19 patients who don’t need hospital admission.
Specifically governed by the ACTIV-4b protocol approved Nov. 1 this particular study is officially titled “A Multicenter Adaptive Randomized Double-Blind Placebo Controlled Platform Trial of the Efficacy and Safety of Antithrombotic Strategies in COVID-19 Adults not Requiring Hospitalization at Time of Diagnosis.”
Targeting 7,000 COVID-19 patients, the multi-center adaptive randomized double-blind placebo-controlled platform trial compares the effectiveness of anticoagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet do not need admission in the hospital as present symptoms are stable.
Recently showcased by Arielle Harrison with KUTV, the investigational team seeks to understand whether a dose of either aspirin or the anticoagulant, apixaban will stop the formation of these potentially deadly blood clots associated with infected patients. These patients are not sick enough to be hospitalized. Utah residents are apparently some of the first participants worldwide in this study; one of the first and largest to emphasize community treatment as part of the study.
Participants in this study are adults between the ages of 40 and 79 years who will be enrolled in up to 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria. The study’s protocol was approved in November 2020 and runs till March 2021. Intermountain investigators and team are slated to enroll and treat several hundred patients in association with this clinical trial.
Director of Research in Emergency Medicine POV
Dr. Joseph Bledsoe serves Intermountain as the director of research within the department of emergency medicine. He was quoted via local press release recently declaring, “This study is looking to see if patients who are less critically-ill from COVID-19 benefit from taking very common medications to prevent the development of blood clots. We want to know if these medications help them from getting worse avoiding hospitalization and death.” Dr. Bledsoe serves on the ACTIV4b protocol development committee as well as the trial’s national steering committee.
Primary Trial Sites
The study is led by three primary investigational centers including University of Florida (Gainesville, Jacksonville) as well as University of Illinois and Intermountain Healthcare. A Florida federal qualified health center known as a Bond Community Health Center also participates in this study.
Salt Lake City-based Intermountain Healthcare (Intermountain) represents one of the most prominent healthcare systems in the United States and the largest such system in this vast region known as the Intermountain West. Intermountain falls under the category of healthcare system as the not-for-profit organization owns and operates hospitals, health centers and clinics but also offers integrated managed care under the insurance brand SelectHealth.
With about 40,000 employees, Intermountain was founded in the mid-1970s when the Church of Jesus Christ of Latter-day Saints donated 15 hospitals as a system to the intermountain community. Now with 24 hospitals, 41,700 employees and 900,100 SelectHealth members, Intermountain sees 512,829 patients in the emergency room in one year and provides $227 million in charity care.
Known as a technological innovator, Intermountain now is expanding with its recent announcement of its intention to merge with Sanford Health. Moving forward, the two systems will employ over 89,000 people across 70 hospitals, 435 clinics and 366 senior care facilities. The merged system will also insure over 1 million beneficiaries.
The Office of Research
The Office of Research manages the shared research services across therapeutic areas at this sprawling healthcare system. With a long and distinguished history of advancing cutting-edge clinical research, over the years Intermountain investigators have been involved in thousands of studies across a myriad therapeutic focus.
Presently, Intermountain conducts over 1,600 studies with a goal to improve the Intermountain delivery of healthcare to advancement of biomedical knowledge.
Call to Action: Those in Utah interested in enrolling in this study or seeking more information can contact Intermountain clinical investigators at [email protected]. Another contact is Research Director Jake Krong at [email protected]