More than 1,000 ongoing and completed clinical trials related to COVID-19 are listed on the World Health Organization’s International Clinical Trials Registry Platform. Another 1,324 federally-funded clinical studies related to COVID-19 are registered with the U.S National Institutes of Health.
That’s more than 2,000 clinical trials in search of the best treatments and vaccines for an infectious disease that didn’t even exist this time last year. Some clinical trials show promise, while others are quickly eliminated for lack of findings.
One recent clinical trial gaining media attention is the small study of famotidine, best known as the active ingredient in the over-the-counter heartburn drug Pepcid.
What is Famotidine?
Famotidine is a histamine receptor blocker. Its compound blocks the H2 receptors responsible for producing acid in the stomach. This is why Pepcid has become a popular heartburn treatment for people with mild gastroesophageal reflux disease (GERD).
Doctors in China who treated COVID-19 patients noted that many of the patients over 80 who survived had been taking heartburn medications. According to early estimates, elderly patients with a history of famotidine use died at a rate of about 14% compared to 27% for those not on the drug. Despite a lack of formal published findings, a team at Northwell Health in New York City were encouraged to explore famotidine’s potential.
Small Clinical Trial Assesses Potential of Famotidine to Treat Coronavirus
On April 7, 2020, COVID-19 patients at Northwell Health were treated intravenously with famotidine at nine times the normal heartburn dose. Although Northwell is one of the largest hospital systems in New York City, this clinical trial was performed quietly. Researchers sought to secure a stockpile of the drug before other hospitals or the federal government, especially since the injectable version of famotidine is not widely available.
“If we talked about this to the wrong people or too soon, the drug supply would be gone,” explained Kevin Tracey, president of Feinstein Institutes for Medical Research at Northwell Health.
Between April 7 and April 25, 1,174 COVID-19 patients, including 187 who were critically ill, have taken part in the clinical trial. Although the trial initially sought to study the efficacy of famotidine alone, all patients at Northwell were already being treated with hydroxychloroquine, the newest “standard of care” for coronavirus.
As a result, this clinical trial is evaluating the clinical efficacy of a combined hydroxychloroquine and high-dose intravenous famotidine treatment, compared to hydroxychloroquine alone. The clinical trial description explains, “The trial will statistically compare the clinical benefit afforded by the two treatment strategies to internal historical “standard of care” data from Northwell patients treated without benefit of either hydroxychloroquine or high-dose famotidine.”
Tracey and his team are hopeful to provide preliminary results by mid-May. If this Phase 3 clinical trial proves successful, famotidine manufacturers can expect to see demand surge.