Physicians, nurses, and all healthcare workers have served heroically during this pandemic, not only in the U.S. but all over the world. Faced with a novel coronavirus and minimal treatment options, and in the case of remdesivir, severe shortages and high cost—Health systems, hospitals and community clinics seek alternative, safe treatments that can save lives. Recently, a pharmacist serving as a director of pharmacy for AdventHealth Ocala faced a challenging situation as COVID-19 cases spiked while the only provisionally approved medication at the time, remdesivir, was in short supply. What does an innovative health system do in this situation? In the case of AdventHealth Ocala, part of the nation’s largest not-for-profit, Protestant-based health system, they tapped into their knowledge and creativity, medical and scientific intellect, as well as drive and desire to save lives, and developed a protocol called ICAM. It appears to be highly effective, observationally. If ICAM proves to work consistently, AdventHealth and Carlette Norwood-Williams, PharmD, have done the nation, and for that matter, the world, a compelling service. Next comes a study to investigate the efficacy of the combination treatment.
Dr. Carlette Norwood-Williams, a Texas Southern University graduate serving as director of pharmacy at AdventHealth, didn’t sit still when faced with growing COVID-19 cases and shortages of the only provisionally FDA approved medication at the time. She got to work on researching alternatives, a process that occurs often before the pandemic at AdventHealth and other clinics nationwide. Now during the pandemic, as TrialSite has reported, health providers often had to take matters into their own hands. A new protocol developed here in Florida shows promise and even received approval for a local study, reports AdventHealth.
The ICAM Protocol
Developed by AdventHealth’s Carlette Norwood-Williams, a pharmacist by training, this protocol was formulated under pandemic conditions, out of the office and based on an understanding of how the underlying therapies actually worked combined with growing observational data as to how COVID-19 was impacting patients.
All medications used in ICAM are within their original FDA indications. No medication used was off-label (or outside indication); however, the specific combination as a regimen is unique, chosen because of the consistent evidence of improvements in inflammatory markers of patients admitted with COVID-19.
What is the ICAM protocol?
It turns out to be an acronym, reports the Ocala Star-Banner & Carlos Medina: I stands for “Immunosupport” and includes Vitamin C and zinc to help boost the immune system. C represents the “Corticosteroid,” Methylprednisolone, which can reduce inflammation in the lungs for augmenting breathing; A equals “Anticoagulant” such as Enoxaparin, a blood thinner that can help stop blood clotting seen in more severe cases of COVID-19; finally, M stands for “Macrolide”, such as Azithromycin, which is often called a “Z-Pac”, and is an antibiotic used to mitigate probability of pneumonia.
So, in summary, the ICAM protocol is a combination of 1) Vitamin C & zinc, 2) corticosteroid 3) anticoagulant and 4) macrolide. Each treatment was considered and selected for its contribution to a problem associated with COVID-19.
In the interview with the Ocala StarBanner, Dr. Norwood-Williams informed that the ICAM protocol was developed based on consideration of …[H]ow patients’ inflammatory response reacted to the medications. In the majority of deaths associated with the virus, COVID-19 is no longer active in the body. Death occurs from the body’s inflammation response to the infection.” So ICAM was conceived and based on this consideration, Norwood-Williams noting, “It provides protection in the body until the virus runs out of gas.”
ICAM Shows Observational Results
This protocol is not used in mild to moderate COVID-19 cases, but rather, those COVID-19 patients admitted to the hospital. Norwood-Williams reports that over 96% of the patients administered the ICAM protocol medication combination have stayed out of the ICU and off respirators—an impressive metric. The Florida pharmacist commented in the health system’s news account, “For 76 days our patients had zero transfers to the intensive care unit, zero mechanical ventilator placement and zero death with ICAM and ICAM similar regimens.”
Now the ICAM protocol has been approved by AdventHealth’s institutional review board and the 100-patient study was just initiated this week. The Marion County study will include participation from the Florida Department of Health (Marion County) and the Heart of Florida Health Center.
Founded in 1973, AdventHealth is a faith-based, non-profit health care system based in Altamonte Springs, Florida. They operate facilities within nine states across America. The Adventist Health System was rebranded as AdventHealth at the beginning of 2019. They are the largest not-for-profit Protestant health care provider and one of the largest non-profit health systems in the United States—with a total of 45 hospital campuses and over 8,200 licensed beds in nine states, caring for over five million patients per year.
AdventHealth Ocala (formerly Florida Hospital Ocala) is also known as the West Florida Division of AdventHealth. In the healthcare system’s website, it declares they have, “Some of the nation’s brightest medical minds making lifesaving breakthroughs with surgical pioneers, scientists and researchers using leading edge technology and innovation to deliver our brand of whole-person care.” TrialSite suggests that based on the real world evidence coming out of this ICAM protocol, the group is living up to, and perhaps exceeding, the brand declaration.
Their network of care includes a number of locations and centers such as AdventHealth Carrollwood, AdventHealth Connerton, AdventHealth Dade City, AdventHealth Lake Placid, AdventHealth North Pinellas, AdventHealth Ocala, AdventHealth Sebring, AdventHealth Tampa, AdventHealth Wauchula, AdventHealth Wesley Chapel and AdventHealth Zephyrhills, as well as five freestanding offsite Emergency Rooms including AdventHealth Brandon ER, AdventHealth Central Pasco ER, AdventHealth Palm Harbor ER, AdventHealth TimberRidge ER, and AdventHealth Westchase ER.
AdventHealth has a robust system of care, including specialty acute care, over 200 primary care and specialty employed physicians, Express Care at Walgreens clinics, urgent care centers, wound care, physical therapy, home care, mobile mammography and more. AdventHealth is a faith-based not-for-profit health care system with a mission of Extending the Healing Ministry of Christ. AdventHealth has hundreds of care sites and nearly 50 hospitals across the United States.
Dr. Norwood-Williams pointed out to TrialSite that this protocol wouldn’t have made it was it not for the support of physician colleagues including Ken Barrick, MD, Emergency Medicine (LSU); Narsing Rao, MD, Internal Medicine (Indhira Ghandi Med College); Mike Mikowski, DO, Critical Care (NSU); Ivan Soosaipillai, MD, Infectious Disease (Seton Hall).
Dr. Carlette Norwood-Williams, PharmD, director of pharmacy at AdventHealth
Call to Action: For those in Marion County that have been diagnosed with COVID-19, consider contacting the local health department of the Heart of Florida Health Center. To learn more about AdventHealth, visit AdventHealth.com, or Facebook.com/AdventHealth, and for the West Florida Division, click here.