The University of Arkansas for Medical Sciences (UAMS) received the greenlight from the U.S. Food and Drug Administration (FDA) as the expanded access treatment program sponsor for the use of convalescent plasma in Arkansas as an experimental treatment for SARS-CoV-2, the virus behind the COVID-19 pandemic. UAMS Medical Center can now use this investigational treatment now without the need to request FDA approval for each and every patient. Moreover, other providers can access the COVID-19 Convalescent Plasma Treatment Program now thanks to the Expanded Access afforded to UAMS.
COVID-19 in Arkansas
With about 3.2 million living in Arkansas, as of this writing the state has 3,694 COVID-19 cases along with 88 deaths. From the numbers, the state is one of the least hit by the pandemic. Over 2,000 of the state’s residents have recovered from the virus.
The Partnership Ensures Arkansans with COVID-19 Access
Thanks to a substantial partnership involving not only UAMs but also the UAMS Transfusion Medicine Services (Blood Bank), UAMS Office of Research Regulatory Affairs in the Division of Research & Innovation, UAMS Translational Research Institute, the Arkansas Department of Health and blood collectors such as the Arkansas Blood Institute not to mention the FDA, a more comprehensive access to convalescent plasma is now available for COVID-19 patients.
Put another way, Tina S. Ipe, MD, MPH, associate professor and director of UAMS Transfusion Medicine Services and project leader for the statewide convalescent plasma effort commented on the study and importantly, the extensive partnership: “This ensures that convalescent plasma collected in Arkansas will benefit Arkansas patients.” Dr. Ipe continued “If we had simply participated in an established nationwide program, much of what was donated here would have gone to hotspots elsewhere. The creation of this program gives us the chance to explore this potential treatment in Arkansas, for Arkansans.”
Faster FDA Authorization in UAMS’ History
As TrialSite News has observed around America (and beyond) research centers have figured out how to accelerate clinical trials ramp up, in some cases shattering records. UAMS is no different: Vice chancellor Shuk-Mei Ho, PhD, reports that the program—including the study—were “possible because of the hard work of many people who were able to get this approval in record time.” Dr. Ho continued, “Creating partnerships, writing protocols and getting FDA and IRB (Institutional Review Board) approval can usually take several months to half a year. Instead our partners got this done in weeks, and the FDA approval came within days of submission. It’s unheard of.” As reported by local news KARK, UAMS shattered records with FDA authorization for this program.
Unprecedented State-wide Collaboration
In addition to shattering FDA authorization and site activation records, UAMS collaborative efforts established unprecedented statewide clinical research-as-care-options for Arkansas residents. This study protocol was designed to open up the research endeavor as to afford access to a wide array of health care providers throughout Arkansas. Now these providers wouldn’t have to go to the FDA for approval each and every time they sought to access convalescent plasma for severely ill COVID-19 patients. Now the entire process is streamlined so that all the providers need to go is go through UAMS as a sort of central clearinghouse for study access. UAMS Chancellor Cam Patterson, MD, MBA highlighted the change to research since COVID-19: “There are currently no approved treatments for COVID-19, so there is a sense or urgency as scientists, public health officials, regulatory staff and others—people who typically stay behind-the-scenes—are hard at work giving our front-line health care workers every tool they might be able to use to help as many patients as possible during these unprecedented times.”
Those seeking to donate plasma must be totally recovered for at least two weeks plus they have possessed laboratory-confirmed COVID-19, meet blond donor eligibility criteria and provide informed consent. The inclusion criteria can be reviewed here or speak with a local doctor.
Donation Centers in Arkansas
Tina S. Ipe, MD, MPH, associate professor and director of UAMS Transfusion Medicine Services and project leader for the statewide convalescent plasma
Call to Action: If you are eligible to donate, consider contacting one of the donation center. Health care providers interested in using COVID-19 convalescent plasma through the expanded access program should contact Dr. Ipe at the following: [email protected]