MAGNIFICENT SEVEN
In order to initiate an expanded access treatment, a protocol must first be writ- ten, submitted for review, and approved by the USAMRDC Headquarters Institu- tional Review Board (IRB), as well as the FDA. An investigational new drug appli- cation must be filed and approved by the FDA, and then have a number assigned to it. To obtain the product, FHP also must have an agreement in place with the prod- uct manufacturer.
“In our case, the product managers of remdesivir were initially under the Joint Program Executive Office for Chemi- cal, Biological, Radiological and Nuclear Defense,” said Army Lt. Col. Sandi Parri- ott, director of FHP. “Tey had it in their portfolio for the Ebola virus.”
In discussions with FHP about using remdesivir to treat a different disease, the initial product managers brought up the idea of the treatment against COVID-19. FHP worked with the product managers
and the Gilead Life Sciences to put into place a cooperative research and develop- ment agreement (CRADA) with Gilead for COVID-19. Te CRADA allowed a cross- reference between Gilead’s FDA-issued number for remdesivir that allowed the Army surgeon general’s sponsorship and use of the product under an FDA-approved FHP treatment protocol to DOD person- nel worldwide. Gilead provided the 2,200 doses at no cost to the government.
FHP was in talks with Gilead for about three weeks
in February 2020. The
CRADA was signed on March 5, received FDA approval on March 17, and the prod- uct was received from Gilead on the same day. FHP received Institutional Review Board approval on March 18, shipped the product to their first site, and treated their first patient on March 26.
Parriott said remdesivir was chosen as a treatment option because it was shown to have activity against the coronavirus in
animal models and in vitro assays. Also, it was the most advanced product iden- tified during market research. It already had a developed safety profile, because it had been used in the Ebola treatment trials in the Democratic Republic of Congo in 2019.
“We knew it was safe, based on the safety profile. We were aware of potential tempo- rary side effects, but it was the most advanced product that was available for a disease we didn’t expect, or have any treat- ment for,” said Parriott.
Patients who are being treated with remde- sivir receive an intravenous injection once a day for five to 10 days, which is deter- mined by the severity of symptoms. During treatment, the physician follows up with the patient to ensure there are no safety issues, providing updates to FHP on clinical progress, laboratory test results, and any potential issues that may be related to the investigational drug. Follow-ups for the patients treated with remdesivir continue for up to 29 days post- treatment. FHP’s main goal is to provide an additional treatment option for patients while providing safety and outcome data to the FDA and the product manufacturer.
CONVALESCENT PLASMA EXPANDED ACCESS PROTOCOL FHP provided an additional expanded access protocol for COVID-19 conva- lescent plasma, which is used to treat COVID-19 patients with plasma taken from patients who have recovered from the virus. As of November 2020, 65 patients had been treated with convales- cent plasma.
THE TREATMENT
Remdesivir is a broad-spectrum antiviral drug used to treat COVID-19 patients. (Photo by Tech. Sgt. Enjoli Saunders, U.S. Air National Guard)
Convalescent plasma is plasma taken from patients who have already been infected with and recovered from COVID-19. Te plasma contains antibodies that can
54 Army AL&T Magazine Winter 2021
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