Susanna Naggie, MD, Vice Dean of Clinical Research at Duke University School of Medicine and Principal Investigator for the HERO-HCQ trial
Adrian Hernandez, MD, MHS, Executive Director of the Duke Clinical Research Institute and Principal Investigator for HERO Program
The RECOVERY Trial, a large randomized controlled trial in the UK, reported findings today that do not show a benefit of hydroxychloroquine when used to treat patients hospitalized with COVID-19, including those with high severity of disease. However, like the Minnesota study which came out earlier this week, this trial also shows that a randomized controlled trial can be done safely to answer important questions about treatment and prevention of COVID-19.
What does this mean for sites and individuals participating in the HERO-HCQ Trial? While these two studies have shown a lack of benefit in hospitalized patients with very advanced disease and post-exposure prevention, these findings do not exclude a possible benefit in pre-exposure prevention. Exploring whether a drug is effective at different stages of disease or prevention is always a worthwhile endeavor, especially in the pandemic we are facing in which there are no approved therapies or vaccines. It is also important to emphasize that the timing of a therapy, particularly in the setting of acute viral infections, can have a significant impact on the effectiveness of the therapy. For example, for influenza, the best chance of preventing the infection is starting treatment either before the exposure or within 48 hours of the exposure.
HERO-HCQ is not the only trial exploring prevention. Our trial and other ongoing randomized pre-exposure prophylaxis studies of hydroxychloroquine will be able to address the remaining questions in COVID-19 prevention and specifically whether being on HCQ before someone is exposed can prevent infection. Due to the role that asymptomatic infection might play in transmission, HERO-HCQ will be able to address whether a prolonged course of pre-exposure therapy can prevent symptomatic and asymptomatic infection. Regardless of the results, this research will provide an important contribution to the scientific community on COVID-19 prevention.