EvergreenHealth Prepares for Second Arm of Clinical Trial After Initial Findings Show Promising Results for Remdesivir as Potential Treatment for COVID-19
The health system has been a leading contributor to the study since its launch in partnership with National Institutes of Health (NIH)
Kirkland, Wash. – Following today’s announcement from the National Institute of Allergy and Infectious Diseases (NIAID), EvergreenHealth is preparing to move forward with the next phase of clinical research studying the anti-viral Remdesivir as a potential treatment for COVID-19. The trial known as the Adaptive COVID-19 Treatment Trial, (ACTT), sponsored by the NIAID, part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
The second phase of the trial, ACTT II, will eliminate the placebo group, and instead provide all study participants with Remdesivir to further evaluate its effectiveness against the virus. The new protocol will also allow for patients currently enrolled in the study and receiving the placebo, to roll over into the group receiving open-label Remdesivir. This means that the nine patients currently in EvergreenHealth’s care and enrolled in the study will now all be eligible to receive open-label Remdesivir, as opposed to the placebo.
According to Gilead and the NIH, results from the trial’s primary ACTT phase, which included 1,063 participants across 68 trial sites, showed that hospitalized patients with advanced symptoms of COVID-19 who received Remdesivir recovered 31% more quickly than those who received the placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving Remdesivir versus 11.6% for the placebo group.
“We are very pleased by the initial findings of the Adaptive COVID-19 Treatment Trial, and incredibly honored to contribute to this significant body of research in the fight against COVID-19,” said Jeff Tomlin, MD, CEO of EvergreenHealth.
Kirkland, Washington-based EvergreenHealth was the first site on the west coast, and the second site globally, to enroll qualifying patients in the Adaptive COVID-19 Treatment Trial (ACTT) in partnership with the NIH’s Division of Microbiology and Infectious Disease (DMID). Normally an eight- to 12-week onboarding process, the hospital was able to launch the trial within only six days in collaboration with DMID partners, who arrived on site on March 7. EvergreenHealth has remained one of the top-enrolling trial sites throughout the first arm of the study, with 34 patients enrolled at present.
“From the very beginning, I’ve been inspired by the way every one of our staff members has jumped into action to come together and launch these research efforts as quickly as possible,” said Dr. Diego Lopez de Castilla, EvergreenHealth infectious disease specialist and lead investigator for the ACTT. “From our nursing to pharmacy teams, it is amazing and humbling to witness this level of teamwork and dedication to exploring new opportunities to potentially advance our ability to provide treatment options for critically ill COVID-19 patients.”
The first arm of the ACTT was double-blind, meaning that qualifying participants were randomized 1:1, with a 50% chance of receiving either the anti-viral drug Remdesivir or a placebo. Following the initial promising results, the second arm of the trial will provide all enrolled patients with Remdesivir.
Additionally, ACTT II will be introducing an immunomodulator, a sister drug used to help regulate the immune system, to study its potential as another treatment for COVID-19. EvergreenHealth will serve as a site for this clinical trial, as well.
EvergreenHealth is currently hosting more COVID-19 treatment clinical trials than any other hospital in the region, with seven interventional trials under investigation and 127 patients enrolled across the COVID-19 interventional study portfolio. The hospital is also the only site in Washington state offering an array of COVID-19 research ranging from diagnostic swabs and treatment, to serology- and vaccine-related trials. In addition to the seven interventional trials, several retrospective chart review studies are also underway to evaluate and fine-tune current standard-of-care practices.
Providers continue to screen COVID-19 patients to determine if they are eligible to participate, working through the consent and enrollment process with participants and their families. The ACTT II is expected to run for three years, with a broader goal of treating more patients with additional investigational treatments as an adjunct to Remdesivir.
“We are honored to be on the front lines of this innovative research in partnership with NIH,” said Anhaita Jamula, CCRC, EvergreenHealth Research Director. “This clinical trial journey has been an important exercise in trust, patience and teamwork across our whole institution. It makes me and the entire research team as grounded in our work as ever, and inspired at the same time.”