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Clinical Trials In North Texas Underway On An Inhaled Version Of Remdesivir For COVID-19 Treatment

A pair of gloved hands inspects a vial of the antiviral drug remdesivir.
AP
/
Gilead Sciences
In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material.

The intravenous version of remdesivir recently approved by the Food and Drug Administration is given to hospitalized patients. Baylor Scott and White are conducting clinical trials on an inhaled version that might avoid a hospital stay altogether.

KERA’s Sam Baker talked with the trial's principal investigator Dr. Robert Gottlieb.

INTERVIEW HIGHLIGHTS

Why test an inhaled version?

We know that remdesivir intravenously works. But the body doesn’t seem to absorb it through a pill form. The idea here is how can we treat patients earlier in their course to hopefully prevent them from needing the hospital and yet (be) outside of the hospital.

You're not going to go pick up an IV medication at your neighborhood pharmacy. We would pick up an inhaler or a nebulizer. So the idea here is directly coat the lungs with the treatment, allow the lungs to absorb the medicine and then protect the most significant organ affected by the disease.

Is that more effective than the IV version?

I don’t know the answer to that because the difference between this is we're going to be protecting mainly the lungs. We don't know how much we'll get into the body and we don't think as very much, but we do see that the virus itself attacks the liver. It can affect the kidneys and certainly the effects of the virus, including the body's immune response is sort of everywhere.

So if we protect the lungs and decrease the amount of virus in the lungs, if we're successful, does that decrease the burden of symptoms elsewhere? Does it also help minimize the aches and pains and other effects?

Who would use the inhaler version?

So if you could get a treatment like this, perhaps you could get a rapid test, find out your diagnosis, confirm it, go pick up the treatment at your neighborhood pharmacy, and get started on the therapy.

And perhaps you might need less days of therapy. For example, for our inpatient IV trial, we actually tested whether five days was as good as 10 days. And we showed that yes, five days was sufficient. So if we capture the virus earlier, if we're lucky enough to show that inhaled remdesivir you're given to the lungs directly works, then perhaps we can give three days instead of five days with the intravenous study.

Tell us about the clinical trial.

The idea is to let patients and providers know that there are options that either this trial or other trials that also focus on different types of antiviral therapies and see which one of them or which several of them might work.

This is for anyone that actually has the coronavirus, but is safe enough to be in an outpatient setting, because if they need a hospital, then we're going to recommend, we have the data to say, come into the hospital, get the IV form of remdesivir.

You need to have a positive test or what we call it: Polymerase chain reaction test, that lets us see the actual genetic material of the virus rather than just the coding.

And we're asking it to be early, within the first four days of that positive test and within seven days of symptoms, because later on, after seven days of symptoms, you've really missed that window to intervene early.

RESOURCES:

COVID-19 patients at two area hospitals first to test inhaled form of antiviral drug remdesivir

Interview highlights were lightly edited for clarity.

Got a tip? Email Sam Baker at sbaker@kera.org. You can follow Sam on Twitter @srbkera.

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