Birmingham, Ala. – Treating severe and critical hospitalized COVID-19 patients using two common over-the-counter (OTC) drugs reduced the inpatient death rates down to 15.5%, compared to published inpatient fatality rates of 21 to 25.7% in New York City, Louisiana, and the United Kingdom. Thus, in essence the dual-drug treatment resulted in a one third reduction in the rate of death in hospitalized patients. They also reduced the intubation rate down to only 16.4% in these high acuity inpatients. The clinical research findings were published in August 2020 in the journal – Pulmonary Pharmacology & Therapeutics.
The drug combination included an antihistamine and an antacid, commonly found on shelves and safely used for decades. These two medications, cetirizine (e.g., Zyrtec(TM)) and famotidine (Pepcid(TM)), work to block H1 and H2 histamine receptors, producing a one-two punch against inflammation and presumably blocking the cytokine storm, according to Reed Hogan, II MD, of GI Associates in Jackson, Mississippi. Hogan initiated this collaboration with pulmonologists from Jackson Pulmonary Associates, who were treating COVID-19 inpatients. “I wanted to see if we blunt the cytokine storm with medications anyone in the world can find and afford,” said Hogan.
The physician-sponsored cohort study analyzed a group of 110 severe and critical inpatients with an average age of 63.7. Based in Mississippi, where general health is often compromised due to socio-economic issues, these very ill patients averaged a high 2.7 in co-morbidities, most notably hypertension, obesity, and diabetes. Of those patients, 59 percent were African-American and 59 percent female.
While many of the other current medical treatments for COVID-19 require expensive drugs or biologics, this protocol uses affordable drugs already on pharmacy shelves. The savings potential could reduce treatment to less than $50 in drug costs, a boon for people without health insurance.
While other research since the initial study shows that famotidine alone may not effective in hospitalized patients, the original study provides evidence of the treatment effectiveness of famotidine in combination with cetirizine in hospitalized patients.
It also appears that H1 histamine receptor antagonists alone are effective in elderly patients, but not in hospitalized elderly patients.
“The two OTC drugs are historically safe, inexpensive, and are readily accessible within both affluent and impoverished countries across the globe. Blocking histamine to reduce inflammation in COVID-19 patients is logical,” said Thomas P. Dooley, Ph.D. a Birmingham, Ala.-based drug developer, collaborator, and coauthor on the study. The two histamine-blocking drugs are already approved for other medical indications by the Food and Drug Administration (FDA), therefore physicians may choose to use this new approach off-label.
Testing on a larger scale in controlled randomized trials is warranted by these initial favorable results, according to Hogan.
SOURCE: Tom Dooley