Now an unusual drug choice for treating a viral infection may have a shot at being a breakout success. Famotidine, best known as the active ingredient in the heartburn drug Pepcid, is being studied in hospitalized COVID-19 patients at Northwell Health, the largest health system in the New York City area. Here’s how this trial got started, and what it may mean for the future of battling the coronavirus.
From Chinese Findings to Testing at the US Epicenter
The idea for the current trial originated in China, where doctors realized that hospitalized patients with COVID-19 tended to have better outcomes if they had preexisting acid reflux disease, according to the lead investigator, Joseph Conigliaro, MD, MPH, the division chief of general internal medicine and a professor at the Feinstein Institutes for Medical Research at Northwell Health. Digging further into patients’ charts, Chinese doctors found that only those who took famotidine — not other acid reflux drugs — experienced better outcomes related to the coronavirus. Laboratory studies and computer modeling confirmed that famotidine appears to be a good fit for the receptor of a molecule that’s involved in replication of the virus. “There was biological plausibility here for why this drug might work,” says Dr. Conigliaro. “It’s a safe drug, a known drug, an available drug. If it works, it would be fantastic.” When he was first approached by colleagues at other institutions about the possibility of conducting a clinical trial of famotidine for COVID-19, Conigliaro says he was initially surprised that this unlikely drug candidate might have merit. But as he looked into the idea, he became convinced that Northwell was in a good position to investigate its effectiveness, and started designing a study and acquiring a supply of the drug.
What Study Investigators Are Looking For
At first, says Conigliaro, the plan for Northwell’s study was to compare four different courses of treatment for COVID-19: intravenous (IV) famotidine, the malaria drug hydroxychloroquine, both drugs together, and the standard of care without either drug. But right before the study was set to begin, Northwell made hydroxychloroquine part of its standard treatment protocol for the coronavirus. So “for ethical reasons, but also for feasibility issues,” says Conigliaro, the study, which began on April 7, has only two active arms: patients receiving hydroxychloroquine, and those receiving both drugs. These two groups will be compared with a historical control group that didn’t receive either drug. The main outcome of interest is mortality after 30 days. The key question, says Conigliaro, is whether adding famotidine results in better outcomes than treating patients with hydroxychloroquine alone. Also, “we’re tracking adverse events to make sure we’re not hurting people by using hydroxychloroquine,” he says, since questions about that drug’s safety have emerged from its recent widespread use for COVID-19. If hydroxychloroquine turns out to have a problematic safety profile, then researchers may consider adding a famotidine-only arm to the trial, says Conigliaro. RELATED: 6 Dangerous COVID-19 Home Remedies to Avoid
Practicing Good Science and Being Patient
Conigliaro stresses that the study needs to run its course before any conclusion can be made about famotidine’s effectiveness as a COVID-19 treatment. “Even though we need to accelerate what we’re doing, we need to be patient enough and trust in the science,” he says. “We have an obligation to see if this works and doesn’t hurt.” If famotidine is found to be an effective treatment, the next step is to figure out how it should be part of the treatment protocol for COVID-19 — when in the course of disease it should be given, in what form, and at what dose. For the current trial, a high dose of famotidine was needed to ensure that any effect from the drug would be noticed. But if that high dose is found to be effective, says Conigliaro, then researchers will need to determine whether a lower dose has similar benefits. “We probably will end up having different dosing,” he notes, in the event that famotidine becomes a mainstream treatment for COVID-19. That may also include oral use of the drug. And if famotidine is found to have promise, Conigliaro says, researchers will have many more questions about the drug: “Can we treat people on an outpatient basis? Does it prevent [COVID-19]? Is it something you can give to medical workers? Those are all great questions that we want to answer, but right now we need to see if it works.”
