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Though Not FDA Approved, Off-Label Singulair Showing Promise As Coronavirus Treatment, Say Doctors

NEW YORK (CBSNewYork) -- As doctors scramble to find effective ways to treat COVID-19, some turn to so-called "off-label" treatments. That's using drugs to fight coronavirus without Food and Drug Administration approval.

One drug that may be showing some success is already in millions of medicine cabinets, CBS2's Tony Aiello reported Tuesday.

At Coney Island Hospital, there is positive news for those admitted with COVID-19 and those first showing up at the intake tent. It's a common asthma drug, Singulair, known generically as Montelukast.

Dr. Caleb Hernandez discussed Singulair on a Zoom call sponsored by and the emDOCs Facebook group.

Hernandez said the disease is very serious with many in need of critical care. He says giving some patients Singulair has shown promise and needs additional study.

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Hernandez said Singulair is helping many hospitalized recover, including one man who said "'I had just told my kids to say goodbye for the very last time.' He says 'After you gave it to me I have hope I'm gonna make it through the night.'"


Hernandez found research by University of Virginia Dr. Tom Braciale, indicating Singulair reduces inflammation in the lungs.

"It may also work by preventing infection of the cells in the lungs that are involved in oxygen exchange. So, if those cells are not infected by COVID-19 the immune system won't destroy them and they will be able to function normally," Braciale said.

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Singulair is not approved as a COVID-19 treatment, but millions have taken it safely for asthma. So, some doctors are comfortable with so-called off-label use during the pandemic, especially with circumstantial evidence of some COVID-19 protection for asthmatics taking these drugs.

"I have great compassion for my colleagues in New York City in the trenches. They start looking for alternative approaches. What we need is a powerful, statistically-based clinical trial to test efficacy of these types of drugs in COVID-19 infection," Braciale said.

He is seeking funding for a trial, as some doctors share the success they're seeing with Singulair and other drugs.

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