Emory University has been a major player in the war on COVID-19, leading key studies and contributing thought leadership—and serving as a key leader in the government-sponsored clinical trial of the COVID-19 drug remdesivir—enrolling more patients in the study than another other site worldwide. Based on emerging study data, federal decision makers are concluding remdesivir a standard of care for COVID-19. There is, of course, more to the story.
The New Standard of Care?
As of this week, there is a growing recognition that remdesivir does have a positive impact on COVID-19 patients. Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases (NIAID), recently described the investigational anti-viral drug as a new standard of care in treating patients hospitalized with COVID-19. It appears to be the first agent with demonstrated efficacy in the treatment of SARS-CoV-2 infections and COVID-19 disease as reported recently by Emory in a press release. However TrialSite News suggests studies need to conclude and a comprehensive set of analyses accomplished before final proclamation.
Why are these Claims being Made?
Emory is basing claims for their recent news release on preliminary data from the major clinical trials involving hospitalized people with advanced COVID-19 and lung involvement who received remdesivir—they appear to recover faster than people who received placebo.
Study Snapshot: Results Look Good
The study was a randomized, controlled trial involving 1,063 participants. Commencing on Feb. 21, the trial was known as the Adaptive COVID-19 Treatment Trial or ACTT, and sponsored by the NIAID. A total of 68 sites joined the study, 47 in the United States and 21 in countries in Europe and Asia. According to NIAID, preliminary results indicate that patients who received remdesivir had a 31 percent faster recovery time than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of eight percent for the group receiving remdesivir versus 11.6 percent for the placebo group (p=0.059).
An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. They noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.
Emory beat out other Sites
Emory and an affiliated hospital enrolled 103 participants, more than any other site worldwide.
Who were the Principal Investigators?
The large Emory team, led by Aneesh Mehta, MD, and Nadine Rouphael, MD, both associate professors in the Division of Infectious Disease. Dr. Mehta reports, “We are extremely happy that the work of this team contributed not only to the advancement of scientific knowledge, but also to helping many of our patients recover more quickly and return home to their families.”
What is the NIAID-sponsored Infectious Disease Clinical Research Consortium?
This group organized under NIAID (which falls under the National Institute of Health) leads the nation’s Vaccine Trials and Evaluation Units (VTEU) which overall enrolled a quarter of all patients in the study. TrialSite News has profiled the VTEUs.
David S. Stephens, MD, professor and chair of the Department of Medicine, Emory University School of Medicine and vice president for research of Emory’s Woodruff Health Sciences Center describes, “The NIAID has created a critical infrastructure to move quickly and engage key leaders in the academic medical community to fight COVID-19 and this successful trials shows the positive results of that effort.” Dr. Stephens is a co-principal investigator in the overall IDRC.
What was the involvement of the National Emerging Special Pathogen Training and Education Center?
This frankly is a sort of “Dream Team” in that they enrolled a quarter of the patients of the entire international study. The National Emerging Special Pathogen Training and Education Center is made up of faculty and staff from Emory University, the University of Nebraska Medical Center/Nebraska Medicine and the New York Health and Hospitals Corporation, Bellevue Hospital Center. All three of these health care institutions have safety and successfully treated patients with Ebola and have worked diligently to share their knowledge with other health care facilities and public health jurisdictions.
Anything Else going on?
Of course, there are a number of clinical trials ongoing, and the timing of the Emory press release was interesting. It came a day after the release of a news release of the study in China that couldn’t recruit enough patients nor generate positive results. TrialSite News observations in California countered as the research is revealing more and more cases where remdesivir does in many cases seem to make a difference. Of course, this was based on anecdotal and other observational data. Now with the Emory news release touting the NIAID findings, it would appear there is a growing consensus among the federal government and major academic medical centers that remdesivir in fact should become the standard of care. This of course benefits the drug’s commercial sponsor, Gilead.
Comment on Bias & NIAID’s Historical Response
TrialSite News gets lots of emails on this topic. As we report on alternative studies (e.g. Ivermectin, etc.) there are concerns that key government, academia and medical system decision makers might lean toward particular investigational drugs over others. The answer of course is yes. There is bias in any system and situation. The medical and scientific community (and the vendors including drug companies) represent human ecosystems that involve many networks and influences. Those companies with track records in fighting infectious disease; with relationships in academia and in government for example can possess considerable clout. This is just a way of life in any society throughout time. On the other hand, there was very little time to respond to this pandemic and NIAID and the various participating research networks had to—and continue to—make decisions quickly as lots of lives are at stake. With little time some top, credible candidates must be considered.
NIAID has had to respond to a pandemic in a rapid, systematic and methodical manner. TrialSite News reported on many instances of this effort ongoing. Regardless of underlying influence and bias, the NIAID must be commended for how they have responded to this crisis. They have moved swiftly and efficiently—participating sites mobilized and commenced activation and startup in record time. Although there have been many instances where federal agencies could be critiqued, overall the mobilization of the research apparatus was frankly a notable point in U.S. history for those that care.
Aneesh Mehta, MD, Associate Professor, Department of Medicine, Division of Infectious Diseases
Nadine Rouphael, MD, Associate Professor, Department of Medicine, Division of Infectious Diseases