COMPLEX MISSION, CLEAR RESULTS
available globally 24 hours a day. Despite the fact that Force Health Protection’s operational mission prohibits research (it merely reports back safety and real-world outcome data to Gilead, the FDA and other interested parties), she can’t help but marvel at the speed of the entire process. Te CRADA with Gilead was signed the first week of March and evolved at a lightning-quick pace. According to Parriott, Gilead sent the first shipment of remdesivir on March 17, with FDA approval of the protocol coming down the same day. Force Health Protection enrolled the first military site in the proto- col just three days later, on March 20 (at Landstuhl Regional Medical Center in Germany), with clinicians treating the first patient on March 26.
“From cooperative agreement to first patient treatment was 21 days,” said Parri- ott. “Tat’s very fast. In our immediate history, it’s definitely a record.”
Parriott further notes—in another nod to USAMMDA’s close relationship with JPM CBRN Medical—that Force Health Protection’s reputation helped drive the effort from the get-go.
“[CBRND] knew that FHP would be the quickest way to get the product out and be able to treat potential DOD members, especially [outside of the continental United States],” she said. “Tis shows the value of having a division like ours that can bring a product that has a lot of promise ahead of the licensure … and have value.”
Te results, so far at least, have been prom- ising. Under the expanded-access protocol, FHP had treated a total of 40 patients with remdesivir as of Aug. 25, with 36 of those (or 90 percent) now considered fully recovered after completing all protocol requirements. Of those original 40, two
32 Army AL&T Magazine Winter 2021
“The ability for us to rapidly use the
CRADA authority to [process] remdesivir has saved lives. That’s not hyperbole. It’s literally saved lives.”
patients were still being actively treated under the protocol.
Still, given the entirety of these results, there can be no doubt that remdesivir holds special promise in the fight against COVID-19. So much so, in fact, that even the behind-the-scenes efforts— from the moment the antenna went up at JPM CBRN Medical to the moment USAMMDA and Gilead sat down with Jeremiah Kelly’s team to hammer out a CRADA and then beyond—are scoring (virtual) high-fives from major players themselves.
“I’m not sure anyone has a full appre- ciation of the tremendous work that is happening all across this command,” said Kelly. “We’re not in the business of toot- ing our own horn, but it’s phenomenal to see what [the command] is doing.”
Parriott can’t help but agree. So far, she points out, the information from the remdesivir clinical trial shows the treat- ment reduces hospitalization time and, also, the antiviral load of the patient, both of which have allowed for quicker recov- ery times. Te FDA noted such ongoing clinical trial efforts in a statement handed down on October 22 announcing its approval of remdesivir as a treatment for COVID-19 in cases requiring hospitaliza- tion. For Parriott, watching an effort like this one—and from such a close vantage point, too—allows for a perspective that reaches far beyond the walls of her office
and, to an extent, even beyond the reach of the command.
“This shows the value of having a
command like ours that can bring a prod- uct that has a lot of promise ahead of the licensure and have value,” said Parriott. “We actually feel like we’re saving lives.”
For more information on the emer- gency-use authorization by the FDA for remdesivir, go to
https://www.fda.gov/ media/137564/download. To read the remdesivir fact sheet, go to https://www.
fda.gov/media/137565/download. For more information on USAMRDC, go to
https://mrdc.amedd.army.mil/. For more information on JPEO-CBRND, go to
https://www.jpeocbrnd.osd.mil/.
RAMIN A. KHALILI is a writer for eLittle Communications Group providing support services to USAMRDC. Before assuming his current role, he spent five years as the knowledge manager for USAMRDC’s Combat Casualty Care Research Program. During his previous work as a broadcast journalist, he earned an Associated Press Award for his work in Phoenix, Arizona, before serving as Chief NASA correspondent for CBS in Orlando, Florida. He holds a B.A. in communications from Penn State University. He is a frequent contributor to Army AL&T and his last article for the magazine, "Dialing up Critical Care," appeared in the Fall 2020 issue.
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