Advent Health Ocala’s ICAM Protocol Takes on COVID-19: Clinician Drives Real World Evidence & Breakthrough

Sep 24, 2020 | AdventHealth, COVID-19, ICAM, Leading Sites, News, Off-Label, Popular Posts, Protocol, Site Success, Site Watch

Advent Health Ocala’s ICAM Protocol Takes on COVID-19 Clinician Drives Real World Evidence & Breakthrough

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: 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.”

The Study

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

AdventHealth

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.

Collaborative Effort

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).

Lead Research/Investigator

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.

32 Comments

  1. Blain Conway

    I BELEIVE IN OUR ABILITY AS A COUNTRY TO COME TOGETHER DURING TOUGH TIMES. IT IS PARTICULARLY INTERESTING THAT WE ALREADY HAVE THE ELEMENTS OF THIS PROTOCOL. UNFORTUNATELY, FOLLOW THE MONEY. THAT WILL DICTATE HOW MUCH SUPPORT THIS SOLUTION GETS. MY GUESS IS THAT IT WILL BE VILIFIED AND DISCREDITED BECAUSE THERE IS NO MONEY IN IT FOR THE BIG PHARMA.

    • Juan Burns

      I ABSOLUTELY DO NOT NOT NOT BELEIVE IN OUR ABILITY AS A COUNTRY TO COME TOGETHER DURING TOUGH TIMES. Yes, Follow the money and you see why: BECAUSE THERE IS NO MONEY IN IT FOR THE BIG PHARMA.

    • D C A Pasea

      I am at a loss to think Big Pharma will not make any profits from drugs listed in the Protocol.
      They just have to produce more. That’s all.

  2. Lindy Bowers

    This sounds like a very promising treatment regime. Your literature says ‘This protocol is not used in mild to moderate COVID-19 cases, but rather, those COVID-19 patients admitted to the hospital’. Isn’t then the problem that it might start out as a mild case and progress too quickly to get the treatment regime started? Just curious.

    • Carlette Norwood-Williams

      Correct. Hospitalized patients were the only patients who received the regimen. 2 weeks ago we were blessed with IRB approval to trial and oral dosage form conversion of ICAM for the outpatient setting (in an effort to prevent the need for hospitalization).

      • Grateful human

        Just a huge personal “thank you” for your dedication, Dr. Norwood-Williams!

        • Carlette Norwood-Williams

          I am grateful for, and humbled by, your appreciation.

          Respectfully, cnw

        • Linda

          Thank you so much.

      • Jerri Jensen

        Curious to know the details of the outpatient regimen that was approved and when the first study results are expected on this new regimen?

      • Barbara

        Thank you, it is a relief to see someone working to combat this from the frontlines. Keep up the great work. I will pass this article on to others working with me.

      • Sharon O Jones

        Thank you for this new information. I am looking forward to future updates on how ICAM is performing for at-home use as well as hospitalized patients.

      • David Shapiro

        Have other hospitals in the country inquired about this method or started to apply it.

        • Kellie Carey

          Curious to know how many patients were treated; I haven’t been able to find that. Wonderful news!

        • Carlette Norwood-Williams

          Good evening, David
          Since this past Thursday, I’ve had inquiry from 15 physicians representing 5 states and 3 countries. Thank you for asking.

      • Joseph Cox

        Dr. Norwood-Williams,

        I live overseas (in Israel) and am in touch with those who might be able to mirror your study. Is there a data package you can provide to support such an effort? We have a massive onrush of cases here and could come up with a thousand patients in a few hours.

        • Carlette Norwood-Williams

          The majority of outreach has been through LinkedIn. Our work is currently under peer review (publication pending).

      • Bob Lear

        Carllette, can someone from Sumter County who has been diagnosed with the virus, and whose symptoms aren’t that bad, qualify to try your regimen of the ICAM? Hat does it take to qualify for this treatment? Thank you so very much.

        • Carlette Norwood-Williams

          Hi Bob

          The investigational review board (IRB) that approved our study only approved the referral sites submitted (local department of health and county health clinics). We’ve received at least 3 inquiries from folks in Sumter County and those individuals have been supported by study physicians through their independent practice, Sir. You may reach me through AdventHealth Ocala and the operators will route you directly to my office. I apologize for my delay in response (my mom called from Texas and told me to find your message).

    • TrialSite

      Hi Lindy,
      Yes promising. We still need low cost, accepted treatments in USA to for mild stage to reduce probability of disease progression.

      Here at TrialSite we are trying to do contribute to that effort but it often feels like an uphill and not straightforward journey. Regards Publisher

  3. David Sandler

    Suggest supplementing with acetylcysteine 10% nebulizer / inhalation solution.

  4. Susan

    This protocol was used with my case. I almost went on the ventilator. Instead, they put me on compressed oxygen and followed this protocol. I was out in 11 days.

    • Sophia Watkins

      This is the protocol I was given as well and had a 13 day stay. I was admitted after realizing that I was unable to take a deep breath, oxygen saturation went down to 91% and I had a fever of 104F. I was placed on oxygen, xrays confirmed infiltrates and I received Tylenol. My labs showed a high D-Dimer (at risk for blood clots) and I was started on the ICAM protocol. By monitoring my vitals at home (I’m a RN), I was able to seek medical intervention in a timely manner.

      • Stanley Michael Mikowski DO DMD

        I am so happy that what we came up with worked….this is what medicine is supposed to be about

      • fermin saja

        a good start…red sage …or black currant might be good aditions….maybe even boswellia….

  5. Carol

    This is a gift from God.Thankyou to all the great minds that thought out of the box…

  6. Robert A Martin

    Please keep me informed. Robert A. Martin, San Francisco, CA

  7. John Lundy

    Let’s just hope that money and government don’t ruin this for us.

    Can we imagine little need for a vaccine? Big Pharma will hate this.

    Now, let us all finish the fight, and continue to support those who are in the trenches at the front lines!

    Thanks to all who have worked diligently and to TrialSiteNews.

  8. Linda

    Thank you so much.

  9. Bill

    Why no Vitamin D supplement? I understand Vit-D deficiency is widespread and the deficiency profile matches closely the Covid bad-outcome profile. The linkage between Vit-D and immune system health has long been established.

    • Carlette Norwood-Williams

      Great question, Bill. I was actually approached by a med school professor from Yale with the same inquiry. We recently approved Vitamin D as an option for hospitalized patients and I absolutely concur with the addition. Actually, the addition of Vitamin D to the hospitalized regimen was submitted for consideration by our lead RD (registered dietician) and it was approved as an option. Nevertheless, I am hesitant with adding it to the outpatient regimen due to concerns with perceptions of pill burden. Considering the >96% survival outcomes, the risk of challenging compliance by adding a 6th pill vs. the 5 meds for 5 days (for most) did not seem to have an overwhelming benefit. The true picture will be painted with the outcomes in inflammatory markers. The objective data should always be the driver in any treatment plan. Thank you asking the question. cnw

  10. Jeff Wright

    THANK YOU FOR YOUR GREAT DEDICATION TO SAVING LIVES! GOD BLESS YOU ALL! I HAVE BEEN WATCHING THE NEWS FOR MORE REPORTING ON THIS SINCE FIRST HEARING IT ON OUR LOCAL NEWS IN ORLANDO, UNFORTUNATELY THERE HAS NOT BEEN THE COVERAGE IT DESERVES. I WILL CONTINUE TO BRING IT UP TO THOSE I TALK TO AND WILL ATTEMPT TO MAKE THE NEWS OUTLETS COVER IT AS WELL. IT APPEARS THAT THE NETWORKS ARE ONLY INTERESTED IN BAD NEWS FOR NOW, I HOPE IT CHANGES…

  11. RickG

    Doctor, this is very similar to Eastern Virginia Medical College’s Dr. Paul Marik’s MATH Plus protocol for hospitalized patients, which had its beginnings in *January*. M = Methylprednisone; A = ascorbic acid (intraveneous); T = thiamine; H = low molecular helperen; Plus = zinc, statin, melatonin, famitodine, magnesium, Vit D,

    Have you been in contact with him?

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