COVID-19 trial lead researcher explains why an antibiotic might work

Medical News Today interviewed Dr. Catherine Oldenburg, co-principal investigator in a brand new human trial examining the potential effectiveness of azithromycin, a common antibiotic, in treating milder cases of COVID-19, which the new coronavirus causes.

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Recently, a team of investigators affiliated with the Francis I. Proctor Foundation at the University of California, San Francisco (UCSF), decided to investigate the potential of a common antibiotic — azithromycin — in treating mild-to-moderate cases of COVID-19 that do not require hospitalization.

The trial — called Azithromycin for COVID-19 Treatment, Investigating Outpatients Nationwide, or ACTION for short — will involve human participants, and the researchers started recruiting on May 26, 2020.

To learn more about the trial, and understand why the researchers chose to study azithromycin, despite specialists typically advising against antibiotics in the treatment of COVID-19, Medical News Today spoke to one of the trial’s principal investigators, Catherine Oldenburg, Sc.D., an infectious disease epidemiologist.

We have lightly edited the interview transcript for clarity.

Why pick a ‘counterintuitive’ candidate

MNT: What is the ACTION trial? Can you tell us a little about its premise and how it will work?

Catherine Oldenburg: The ACTION trial is a nationwide trial in the United States that is designed to evaluate the efficacy of a single dose of azithromycin compared to placebo for [the] prevention of hospitalization in COVID-19 patients who are not currently hospitalized, so patients who have […] anywhere from asymptomatic to moderate disease that doesn’t require hospitalization, and the trial is designed to be flexible and scalable.

It will be open to patients nationwide in the U.S.; it’s conducted remotely out of our trial coordinating center at UCSF.

So, patients can contact the study team from anywhere in the U.S. and be screened remotely, go through all [the initial] processes, and then we ship them [the] study drug and sample collection kits.

MNT: How did you and your team zero in on azithromycin as a potential treatment for COVID-19?

Catherine Oldenburg: It’s a great question. I think that […] it’s absolutely true, the mantra that […] antibiotics don’t treat viral infections. And so, it’s a little bit counterintuitive [to use azithromycin in the treatment of COVID-19, which is the result of a viral infection].

My team has been working with azithromycin and studying [it] for a number of indications for decades. Proctor [The Francis I. Proctor Foundation at UCSF], in general, has been working with azithromycin for trachoma control, which is an infection of the eye, [for] the last 20 years.

And so, in terms of trials [for] azithromycin, that’s something that we do a lot of. I have something like eight trials going on right now with azithromycin, most of which are for trachoma, or for childhood mortality in Sub-Saharan Africa, where there’s a large burden of bacterial disease that’s [an existing issue].

But one of the interesting things about azithromycin is that it has really strong immunomodulatory effects, so it has these kind of nondirect effects on the immune system. That means it’s an interesting candidate in terms of what it does to the immune system.

So, in vitro, there have been reports showing that azithromycin has activity against RNA viruses like Zika and rhinovirus and things like that.

And then […], I don’t remember the exact date, but there was a study out that kind of created a lot of hype around azithromycin in combination with hydroxychloroquine, and that’s sort of when we got interested, [thinking]: If there’s any indication that perhaps azithromycin has an effect against COVID-19, or against SARS-CoV-2, perhaps that’s something that we should be taking a look at because our team really has a lot of expertise in terms of azithromycin trials, specifically, and in conducting large trials.

Azithromycin is very safe; it’s prescribed all the time for all kinds of things; it’s something that people are very familiar with in a Z pack in the U.S. It seemed like a good candidate for outpatients — if it had an effect — because of its safety profile. And we decided to look at it independently of hydroxychloroquine, given concerns about [the latter’s] safety.

There are a lot of other trials going on with hydroxychloroquine, and we didn’t really feel like we needed to get involved in that because that was outside of our area of expertise.[…] That [is why] we’re looking at azithromycin by itself.

And, we thought, given the safety profile of azithromycin, that this [drug] could be potentially valuable [in treating COVID-19], and to have that kind of evidence would be really useful.

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