By Brandon Webb, MD, Infectious Disease Specialist
The Food and Drug Administration issued new guidance Monday that revokes the previous Emergency Use Authorization of chloroquine and hydroxychloroquine for COVID-19 and now restricts the drugs’ use to COVID-19 clinical trials only. The announcement aligns with National Institutes of Health COVID-19 treatment guidelines, which also states these drugs shouldn’t be used to treat patients outside of clinical trials.
What is an Emergency Use Authorization? An Emergency Use Authorization, or EUA, is a temporary FDA status allowing use of an unapproved drug during a crisis while the creation of a clinical trial is in progress. Once an EUA is issued, the evidence for a drug is continuously reviewed and the terms of the EUA are subject to change as new evidence becomes available.
Hydroxychloroquine to still be administered in clinical trials. The FDA clearly says hydroxychloroquine will continue to be administered through clinical trials. The EUA designation was revoked because of the difficulty of justifying the drug’s use for an unproven purpose when preliminary data hasn’t shown promising results. Although two small randomized, controlled trials did suggest a possible benefit in less-severe patients, several uncontrolled studies and the large controlled trial — called the RECOVERY UK study — did not find that hydroxychloroquine or chloroquine reduce mortality in hospitalized patients. The new FDA statement only refers to or affects uses of hydroxychloroquine outside clinical trials and recognizes that multiple other large, well-designed, randomized controlled trials continue to safely enroll patients in the hospital and in the outpatient settings, which will help find conclusive answers.
How does Intermountain ensure patient safety? Intermountain has been aligned with FDA guidance since the beginning of the pandemic and supports these recent changes. Clinical trials provide the ideal environment for providing access to investigational medications, not only because they provide answers to whether a treatment works, but also because trials are designed to ensure safety and patient rights are carefully protected.
A primary motivation for the launch of the local hydroxychloroquine trials (HAHPS, HyAzOUT and the Utah COVID Trial) was to provide Utahns with COVID-19 access to these medications in a safe and supervised way. Trial investigators received permission from the FDA (called “IND exemption”) to conduct these studies and remain confident that they’re designed to optimize the safety of participants. Candidates for these trials are first carefully screened for medications or conditions that increase risk for heart rhythm problems and other potential safety hazards before they’re allowed to enroll. Once enrolled, patients are monitored every day for any signs of adverse events. By following these procedures, trial investigators have been able to identify potential risks before they occur and ensure study medications are being prescribed in a safe way.
In addition, each trial has an independent safety monitoring panel, consisting of experts from other institutions who regularly review trial data and have the power to stop the trials if they identify concern that these drugs may cause harm. So far, these experts haven’t identified any concerns for harm. Intermountain investigators will continue to review all available evidence, follow FDA guidance, follow the instructions of their safety monitoring panels, and will participate on a panel with NIH officials to continue to further explore these issues.
For more information about clinical trials, visit Intermountain’s COVID-19 Clinical Trials website.