Thread by @CatieOldenburg

Our #RCT of #azithromycin vs placebo for outpatient #COVID is out today in @JAMA_current

Tl;dr – azithromycin doesn’t help improve symptoms in outpatients with COVID and might make things worse, so don’t use it. 1/n

jamanetwork.com/journals/jama/…

Why did we do this study? Azithromycin was identified early on as a potential candidate for COVID (+/- HCQ). Although it’s relatively safe, antibiotic use causes antibiotic resistance, and unnecessary widespread use of an antibiotic is a bad call. We need to know if it works. 2/n

There were some reasons to think it MIGHT work: azithromycin has anti-inflammatory properties and is used in other pulmonary diseases to reduce inflammation and has some in vitro anti-viral properties. But that doesn’t necessarily translate to efficacy, so we need a trial. 3/n

Azithromycin has been widely used for COVID globally and many people told us they felt better after taking it. Without a trial, we don’t know if that’s a real effect, if people were getting better anyway, or of it was a placebo effect. 4/n
journals.plos.org/plosmedicine/a…

We chose a masked, placebo-controlled design with a matching placebo to minimize some of these biases. Participants were randomized to single dose #azithromycin or matching placebo after enrollment and followed remotely for 21 days. 5/n

The primary outcome was absence of symptoms 14 days after enrollment. It was a dead heat between arms: exactly 50% of participants in each group were symptom-free at 14 days. We saw no evidence of a difference in specific symptoms, either. 6/n

Participants receiving #azithromycin had more gastrointestinal adverse events vs placebo, not surprising. Those in azithromycin arm visited emergency dept more often, and all 5 hospitalizations in azithro arm - numbers are small for those comparisons so interpret w/ caution. 7/n

As with any study, lots of limitations. Some biggies are sample size (underpowered for impt outcomes like hospitalization) and relatively high loss to follow-up (~25%). Recruitment was slower than planned and retention was difficult b/c remote trial. 8/n

Results are largely in line with another azithromycin for outpatient COVID trial published this week. 9/n thelancet.com/journals/lanre…

Overall takeaway: no evidence that #azithromycin helps for #COVID19 symptoms or other outpatient endpoints; some evidence it may make things a little worse. IMHO, no role for azithro in #COVID19 management w/o bacterial co-infection. 10/end