It began with a treatment for skin inflammation. Then, Reed Hogan II, MD, began pondering if an inexpensive, available, over-the-counter treatment might also work in severe gastrointestinal illness, much of it caused by inflammation. The Clarksdale native was seeing success. Then, COVID-19 hit. He connected the inflammation dots, and wanted to attack the cytokine storm of the novel virus.
He contacted a leader in the nation’s largest pulmonary organization to start a physician-sponsored study with critical hospitalized patients. The result: his team cut death rates by 25-40-percent, down to 15.5-percent, and 8.2-percent not including those with DNRs (do-not-resuscitate orders). They also reduced the intubation rate (need for a ventilator) down to 16.4-percent, a reduction of 1/3 to 1/2 of reported rates in the pandemic.
“I wanted to see if we blunt the cytokine storm with medications anyone in the world can find and afford,” said Hogan, partner with GI Associates in Jackson, Mississippi. The study was not sponsored by a pharmaceutical company or government grant, but by the physicians of GI Associates themselves.
Working to treat a large group of patients, many already in intensive care units, the ages of these very sick patients skewed towards 60-plus in age, with many coming from nursing homes. Based in Mississippi, where general health is often compromised due to socio-economic issues, these patients averaged a high 2.7 in co-morbidities (other health problems). Of those patients, 59-percent were African-American and 59-percent female, according to the data.
The selected drug combination included an allergy (antihistamine) and an antacid (acid-reducing drug), commonly found on shelves that have been safely used for decades. While the answer appears simple, it is actually quite complex. These two meds, cetirizine and famotidine, work to block H1 and H2 histamine receptors, producing a one-two punch against inflammation, a deadly factor the cytokine storm of COVID-19, according to Hogan.
With the historically safe nature of these common drugs, and the lack of other proven therapies, Dr. John Studdard, well-known for his leadership in pulmonary medicine, and the physician practice group, Jackson Pulmonary Associates, agreed to try the treatment in critically-ill patients. Two weeks later, positive results began to emerge. This meant sending people once on the edge of dying, home to complete recovery.
“It was pretty dramatic. We thought the data might be too good to be true, but the positive results kept coming,” said Hogan.
While many of the other treatments being offered require specialized equipment, or expensive drugs or biologics, this protocol uses drugs already on pharmacy shelves. The savings could reduce treatments that cost in excess of $3,000, to potentially less than $100 in drug costs.
“The drugs are so scalable, easy to produce and inexpensive, that this combination should be readily accessible to impoverished countries across the globe,” said Hogan.
While the drugs they are using have long had approval from the Food and Drug Administration (FDA), still their new approach is off-label, thus not currently approved for the treatment of COVID-19. This initial study included a cohort of 110 patients. The research article has been submitted for publication review; a preprint of the manuscript is available at
https://doi.org/10.22541/au.159406460.01530066
Testing on a larger scale in well-controlled, rigorous trials are warranted by these favorable results, according to Hogan.
“It is an optimistic result in a time when people are vulnerable. Dr. Hogan is striving to do good in a time of need. This has the potential to be a remarkable weapon against this worldwide pandemic,” said Douglas Paul, PharmD PhD, partner in Medical Marketing Economics.
