- Researchers are looking into whether high doses of famotidine, the active ingredient in the heartburn medication Pepcid, could be used to treat critically ill patients with COVID-19, the disease caused by the novel coronavirus.
- The researchers are based at the Feinstein Institutes for Medical Research, the research arm of New York health system Northwell Health.
- A clinical trial is underway, and researchers want to recruit 1,200 patients.
- It’s too soon to know whether the drug will work in treating COVID-19, a disease with no clinically validated treatments to date.
- Visit Business Insider’s homepage for more stories.
Researchers at New York hospitals have been quietly testing whether a common heartburn medication might help critically ill patients with COVID-19, the disease caused by the novel coronavirus.
The researchers are affiliated with the Feinstein Institutes for Medical Research, the research arm of New York-based health system Northwell Health. They’re currently running a clinical trial to test whether high doses of famotidine help critically ill coronavirus patients survive.
They’re testing a dose that’s nine times the amount of famotidine, or Pepcid, that someone would usually take to treat their heartburn. It’s delivered intravenously over a period of seven to 10 days. Patients in the study also get hydroxychloroquine, a malaria pill that’s being evaluated to see if it can treat the coronavirus.
The evidence the researchers are relying on to begin their trial is anecdotal. And there’s no evidence yet from the trial itself that suggests famotidine is useful in fighting the coronavirus. Science magazine first reported on the study yesterday.
Famotidine is the latest of dozens of drugs that are being tested in the treatment of the novel coronavirus, for which there are no approved treatments to date.
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The trial, which began earlier in April, at first was kept quiet in the interest of making sure the investigators had enough famotidine to complete the trial, which will include 1,200 patients.
“We didn’t want to see supplies depleted for the clinical use for the COVID-19 studies or for the use of patients with serious medical needs,” Dr. Kevin Tracey, the president and CEO of the Feinstein Institute, told Business Insider.
He pointed to the shortages that emerged when experimental treatments like hydroxychloroquine were first discussed.
“For us there was a concern that people would run out and buy famotidine without scientific evidence,” he said.
Why Northwell’s exploring famotidine
Tracey and the team at Northwell first heard about the potential for famotidine to treat seriously ill COVID-19 patients from Michael Callahan, a doctor affiliated with Massachusetts General Hospital and the biotech company United Therapeutics. There were two anecdotes that he had on hand to support more research into using famotidine in the treatment of COVID-19, Tracey said.
- Callahan had traveled to China to see how the disease was being treated. There, he had seen that patients who were on heartburn medications tended to do better when they were on famotidine .
- Upon return, researchers affiliated with the Department of Health and Human Services ran the drug through a computer model that the drug bound to the active site on the virus.
At the time, Northwell’s 23 hospitals were at the center of the outbreak in the US and were mobilizing clinical trials to validate which treatments might work against the disease and which might not. To date, the organization has six clinical trials underway.
“We were confronted with something even today there is zero, no clinically proven effective therapy. Zero,” Tracey said.
The researchers had to weigh the safety of the drug with the potential it might have in helping very sick patients recover. “That was the barrier,” Tracey said.
Treating hospitalized patients with famotidine
The double-blinded trial run by the Feinstein Institute is randomizing patients either to receive famotidine intravenously alongside hydroxychloroquine, or hydroxychloroquine alone. They’ll be evaluated against a control arm of patients treated earlier in the crisis.
Those on the trial are hospitalized and have bilateral pneumonia and low oxygen levels in the blood as a result of the novel coronavirus.
The patients undergo treatment for seven to 10 days, based on estimates of how to dose the medication high enough so that it might turn the virus off and keep it from replicating.
“Our first choice was not to have hydroxychloroquine in all patients,” Tracey said.
However, by the time the trial went underway the antimalarial medication had become a standard part of treating hospitalized patients, making it difficult to find patients who weren’t on the drug.
The researchers are looking into whether another arm can be added to the trial just evaluating famotidine without hydroxychloroquine.
So far, 150 patients have been enrolled into the famotidine and hydroxychloroquine trial, a spokesman for the Feinstein Institute told Business Insider. To the organization’s knowledge, it’s the first clinical trial looking into whether famotidine helps in treating cases of COVID-19.
The ultimate goal of the trial will be to see whether the medication helps patients survive COVID-19, evaluating how many have survived after 30 days compared to those who didn’t receive famotidine.
Researchers will also be looking at the amount of the virus in patients’ bodies, if their oxygen levels improve, and if their stays in the hospital are shorter than those who didn’t receive the treatment.
“What we’ll know is whether patients derive benefit or harm,” Tracey said. “What they won’t know is how exactly the drug is working if it does.”
It’ll be important to see the results of the trial before making any decisions about whether famotidine should be used in more widespread treatment of hospitalized COVID-19 patients.
“We need the trials. We need it randomized, and we need it controlled,” Dr. Thomas Maddox, who serves as chair of the science and quality committee of the American College of Cardiology, told Business Insider. “If you don’t do that, you don’t know what the specific impact of any given drug is on a disease.”
After reviewing some of the specifics of the trial published in Science Maddox said he was “amazed” at how quickly the trial was designed and put into action.
There are still no proven treatments for COVID-19
Beyond the evidence the Feinstein team kept in mind when deciding to begin a famotidine trial, there isn’t much to suggest that the heartburn medication is a potential treatment for hospitalized COVID-19 patients.
While famotidine is found in Pepcid, an over-the-counter medication, there’s no evidence to support its use as a preventive measure or as a treatment for the novel coronavirus.
“All drugs have side effects. Famotidine has side effects. Drugs should not be taken without being guided by a physician,” Tracey said. “We don’t know if famotidine will cause more harm than good.”