Both Vanderbilt Medical Center and Williamson Medical Center have joined the Healthcare Worker Exposure Response and Outcomes (HERO) clinical trial, a federally-supported research effort investigating the effectiveness of plaquenil hydroxychloroquine in preventing the contraction of COVID-19. Sponsored by Duke University and in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), the investigators hope to determine if the experimental treatment can help prevent the virus.
Can a drug that President Donald Trump touted as “a game changer” actually work? Will plaquenil hydroxychloroquine help protect health care workers and first responders on the front line in the battle against COVID-19? The HERO study was designed to help the medical community find out.
This clinical trial has been organized as a double-bling, placebo-controlled effort targeting up to 15,000 health care workers at risk for exposure to COVID-19. Up to 40 clinical investigational sites will enroll eligible participants and randomly assign them (1:1) to either treatment group of A) the study drug, or B) placebo in a double-blind fashion. Once enrollment occurs, the team will undertake baseline assessments such as nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. The study started April 20, 2020 and runs till July 2020. As of this writing, 20 of the 40 sites have been selected.
Digital Collaborative Engagement: An Investigator Portal
Duke is ramping up digital technology given the current conditions: an investigator portal has been set up to facilitate weekly follow-up meetings with participants. Moreover, the study sponsor has included a call center to support those that missed visits. Follow-up visits include screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessment.
30 Day Course of Treatment
With a 30-day course of treatment, participants follow up via a weekly survey. Once the treatment ceases, the participants will return for a repeat nasopharyngeal swab for the virus and another blood sample to detect seroconversion to COVID-19. After that, the study design includes one last contact 2 months from baseline.
Participating Sites doing Well
Participating sites, such as Vanderbilt, may enroll up to 375 people. The Nashville Post reports that just 24 hours of being enrolled in the program, Williamson Medical has enrolled close to 100 participants! The hospital looks to expand the number of participants and encourages others to apply.
A Special Investigational Site: Williams Medical Center
With already 100 participants enrolled in 24 hours, the center is not slowing down. Aaron Milstone, a pulmonary critical care specialist (and principal investigator for the HERO trial on behalf of Williams) reports “While we’re really good at recruiting at the medical center, this is going to be open to police departments, EMS, and fire departments.” He continued, “It’s a whose who of major medical centers; its Columbia; its Michigan, its Penn State…We are really—in the first batch—the only non-academic medical center to be selected.”
Williamson Medical Center has been around for over 60 years. The provider has evolved alongside the communities in this part of Tennessee, from what was purely a rural community to a burgeoning region. It ranks in the top ten percent of hospitals nationwide for overall surgical care and patient safety. Their medical providers consist of more than 750 highly skilled board-certified physicians and a staff of 1,800 employees.
Williamson Medical Center
Aaron Milstone, MD, FCCP
Call to Action: If you are a health care workers or first responder (e.g. EMS, fire or police) and want to contribute to the war against COVID-19 in Tennessee, reach out to Williams Medical Center or Vanderbilt University.