Clinical trials for potential treatments for COVID-19 have gained major media attention even before they started, leading to high hopes and acute shortages for patients who depend on the some of the drugs to manage lupus and cure malaria. When Northwell Health contemplated running a trial of another medication at its 23 hospitals in New York, the healthcare organization sought to avoid publicity entirely.
The drug Northwell’s testing, famotidine, is an old treatment for heartburn, available as a low-cost generic in both pill and IV form and as the OTC mainstay, Pepcid. Northwell hoped to keep its plans quiet until it could secure a sufficient supply for the study, Science reported on Sunday.
For pharmacists, the Northwell team’s reticence has the advantage of avoiding a run so far on famotidine, which more people have been using for heartburn since the FDA pulled all ranitidine products off the market on April 1. As word of the trial gets out, though, that may change.
By last weekend, the investigators had enrolled 187 coronavirus patients in critical condition, many of whom were on ventilators. They aim to include 1,174 patients in the trial in total and evaluate interim results after 391 patients.
The study was prompted by early observations that poorer Chinese patients with COVID-19 tended to have better survival rates than wealthier patients. They were also more likely to be taking famotidine for heartburn than the more expensive omeprazole. In a rough analysis of the data, the hospitalized patients on famotidine had about half the mortality rate of patients not on the drug, although the difference was not statistically significant.
Subsequent modeling of an enzyme involved in SARS-CoV-2 replication and computer testing of 2,600 different compounds that the FDA has deemed safe against that model also suggested that famotidine might keep the virus from multiplying.
Patients in the Northwell study are randomized to receive either famotidine IV at about nine times the dose used for heartburn or a saline solution. They are all also receiving hydroxychloroquine, though future patients may not receive it given the FDA’s warning last week against its use because of adverse effects. Hundreds of COVID-19 patients treated earlier who received none of the medications will form the control arm of the study.
The earliest peek at the outcomes from the Northwell study will not be available for weeks. The researchers themselves say they just don’t know if famotidine will make a difference.
So, if a patient tries to buy an unusual amount of Pepcid, caution them that the trial is still underway and buying more than they’re likely to use could just give them more heartburn if the study finds the drug is ineffective in COVID-19.
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