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Posted By: Lawrence Herman, PA-C, MPA
May 29, 2020
The World Health Organization (WHO) is but another organization to halt a COVID-19 therapeutic trial due to safety concerns. Specifically, WHO suspended the hydroxychloroquine arm of the Solidarity trial. Solidarity is a trial examining four different treatment protocols (remdesivir, lopinavir/ritonavir, interferon beta-1a, and hydroxychloroquine), and is recruiting from 400 hospitals in 35 countries. Thus far, 3500 patients from 17 countries are enrolled.
Other clinical trials are examining chloroquine or hydroxychloroquine with or without an advanced macrolide, most commonly azithromycin. Even though some are observational trials, the results are strikingly worrisome. With control for confounding factors including age, sex, race/ethnicity, body mass index, cardiometabolic disease history, immunosuppressed condition, lung disease, and smoking status, every combination of chloroquine, hydroxychloroquine, and a macrolide therapy was associated with an increased risk of in-hospital mortality versus other COVID-19 therapies. Collectively, these trials enrolled a staggering 63,315 patients in North America alone.
- Hydroxychloroquine: 18.0% (hazard ratio [HR], 1.335; 95% confidence interval [CI], 1.223-1.457)
- Hydroxychloroquine plus macrolide: 23.8% (HR, 1.447; 95% CI, 1.447-1.368)
- Chloroquine: 16.4% (HR, 1.365; 95% CI, 1.218-1.531)
- Chloroquine plus macrolide: 22.2% (HR, 1.368; 95% CI, 1.273-1.469)
- Control: 9.3%
Risk of patient de novo ventricular arrhythmia during hospitalization was, again, significantly increased with every combination of observed chloroquine/hydroxychloroquine therapy versus control:
- Hydroxychloroquine: 6.1% (HR, 2.369; 95% CI, 1.935-2.900)
- Hydroxychloroquine plus macrolide: 8.1% (HR, 5.106; 95% CI, 4.106-5.983)
- Chloroquine: 4.3% (HR, 3.561; 95% CI, 1.935-2.900)
- Chloroquine plus macrolide: 6.5% (HR, .4011; 95% CI, 3.344-4.812)
- Control: 0.3%
Despite the pressure on clinicians to utilize potential therapeutics, it is important to stay up to date on clinical trials to avoid using those therapeutics showing a clear increased risk of negative outcomes.
- Kunzman K. WHO suspends hydroxychloroquine treatment in COVID-19 Solidarity trial. www.contagionlive.com/news/who-hydroxychloroquine-treatment-covid-19-solidarity-trial. Accessed May 27, 2020.
- World Health Organization. "Solidarity" clinical trial for COVID-19 treatments. www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments. Accessed May 27, 2020.