It has been a month since Donald Trump tweeted that hydroxychloroquine may be a big game changer for the treatment of COVID-19. Since that time, the FDA granted emergency use authorization for this medication in the case of hospitalized patients who do not have access to a randomized clinical trial. Unfortunately there have not been many robust clinical trials to date and people are still unsure if this medication works.
A preprint was recently posted that described the results of an open-labeled, randomized controlled trial for 150 hospitalized patients. In this post, I’ll take a deeper look at this study.
Study Design
Hospitalized patients in Ruijin Hospital, China were randomized either to standard of care or standard of care with hydroxychloroquine.
Hydroxychloroquine was provided the same day of randomization. 1,200 mg daily were given for three days followed by 800 mg for the remaining 2-3 weeks. Just for reference, this is 2-3 times greater than the dose provided in France and in the United States.
Patient Demographics
These patients were relatively healthy, with an average age in the 40s and most had moderate COVID-19, although the authors did not describe what constitute moderate disease. One potential confounder is that more patients in the hydroxychloroquine arm had preexisting comorbidities, shortness of breath, and higher CRP and IL-6 levels upon initial presentation.
Adverse Effects
It is no surprise that patients with hydroxychloroquine had more adverse effects. The most dangerous complication is arrhythmia from QT prolongation, but that is not reported here.
Results
Hydroxychloroquine did not lead to greater viral clearance of SARS-CoV-2 as detected by PCR compared to standard of care. There was no significant improvement in clinical symptoms with this medication as well compared to standard of care treatment. This pretty much kills the idea that hydroxychloroquine is a cure for COVID-19. The authors do report there is some reduction in IL-6 and CRP levels, but at the end of the day, we care about clinical improvement and the results clearly show that that hydroxychloroquine is not some sort of magic cure.
Conclusions
This likely is a practice changing trial. Every hospital in the world has been empirically providing hydroxychloroquine for treatment given a few in vitro results and two small randomized trials. However, this medication does come with side effects and there is no clear evidence that hydroxychloroquine significantly improves symptoms or decreases viral load.
I suspect every hospital will start cutting back on their use of hydroxychloroquine.
