I wish this was a positive study regarding hydroxychloroquine (HCQ) for postexposure prophylaxis but unfortunately it is not. Let’s start off with a bit of a head scratcher. I’m struggling with how they worded the study “Postexposure prophylaxis”. Prophylaxis, by definition, means “action taken to prevent disease” per the Oxford dictionary. But if you are already exposed and may probably have the virus, is it really prophylaxis? Okay I may be too fixated on that. I digress.
They started the treatment within 4 days of the exposure which is the best they could do, I guess. It somewhat helps us guide the concern of starting it early for best efficacy that remained unanswered. Hats off to the authors in the University of Minnesota and at the University of Manitoba. This study was published today. Let’s get to it! Please read it for yourself and don’t trust my interpretation. The links are all the way at the bottom.
If you want to learn more about the outpatient studies regarding COVID, CLICK HERE.
We have no medications to help us decrease COVID transmission. We could all live in bubbles with hazmat suits but this isn’t actually feasible. Standard of care is to stay home for 14 days if you have an exposure. The cited risk of secondary household transmission is 10-15%. I would’ve thought the number was higher if I am honest. Taking care of these patients it seems like mostly everyone in their house is sick.
Methods: Lots of things done right.
This is a randomized, double-blind, placebo-controlled study. Yum. They got either the HCQ or placebo. Participants had to have a known exposure to someone with actual diagnosed COVID-19. I like it. They had to be enrolled within 3 days of exposure. So many goodies! They wanted to start the study within the incubation period. They did extend their eligibility during the trial. The trial purists would be mad. I’m not mad, though. The authors are specific in detailing what they consider an exposure.
How did they find these people? Social media of course! In addition, they used traditional media outlets. All the follow-up was done via email and then got more assertive with texts, phone calls, and eventually an emergency contact if the people didn’t respond. Adherence to such trials is a pain in the butt, as you will see. The authors called it “moderate”. Since this was done online and not at academic centers, they were able to get a wide distribution of patients.
They ended up with 821 patients. 414 in the HCQ group and 407 in the placebo group. 66% of the patents in the study were healthcare workers. Their exposures came mostly from patients or co-workers. The story of our lives, right? This also means that the majority of patients were younger and healthier, leaving questions as to whether it could work better in at-risk populations.
Dose of Hydroxychloroquine
The dosage included a 5 day regimen of 800mg by mouth once, 600mg 6 to 8 hours later, then 600mg daily for 4 days.
Outcomes of giving hydroxychloroquine (HCQ) for prophylaxis
The primary outcome was symptoms plus a positive COVID test or COVID symptoms. The COVID symptoms are listed on the paper and are ultimately what you would expect. There was no statistically significant difference in giving patients hydroxychloroquine.
The secondary outcomes were numerous. Only one patient in each group ended up in the hospital. No one had an arrhythmia, by the way. They did, however, have nausea, abdominal discomfort, and loose stools in the HCQ group.
Wrapping it up
They did not test everyone in the trial to see if there were asymptomatic carriers. This is a large flaw in the study. Then again, if the testing isn’t available, then can they do it? Patient enrollment started in March. Testing wasn’t exactly abundant then. Can’t say it’s even abundant now. But this means that they cannot assess the effects on patients who are asymptomatic or have mild infections.
They did not do subgroup analyses on the older folks. The median age was just 40-41 years old. 70+% of patients had no comorbidities.
Should those of us who are in healthcare take hydroxychloroquine (HCQ) for postexposure prophylaxis? This data says a whole bunch of nope. But what about people who are older with more co-morbidities? We don’t know. My inclination says no.
Citation:
Boulware DR, Pullen MF, Bangdiwala AS, et al. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020;383(6):517-525. doi:10.1056/NEJMoa2016638
Link to Article
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