IMPROVING THE FIGHT
The intent of drug treatment is minimized hospitalization, critical care treatment and survival of COVID-19 patients.
On June 19, 2020, USAMMDA and the U.S. Army Medi- cal Research Acquisition Activity (USAMRAA), subordinate commands of the U.S. Army Medical Research and Develop- ment Command, awarded Ophirex, Inc., a $9.9 million contract to manufacture two versions of the drug—a tablet and an inject- able version—to be tested in clinical trials starting this year. Te tablet, to be taken orally, is intended to treat moderate or recov- ering cases. Te injectable version can be infused into patients with more severe symptoms.
“Tis drug doesn’t kill SARS-CoV-2. Instead, it is anticipated to stop what the virus does to the body—the symptoms of COVID- 19 that are killing people and keeping them in the hospital,” said Dr. Lindsey Garver, product manager for this effort within the WPAC Project Management Office. “Since it’s already been studied for other purposes, we know a lot about its safety profile and can move very quickly to implementation and, hopefully, saving lives.”
Varespladib is currently being evaluated as a treatment for venom- ous snakebites. It was previously tested against sepsis and acute coronary syndromes—trials that showed it to be safe and well- tolerated in patients, though not particularly effective in those conditions.
Regulatory progression of BioFire Defense’s COVID-19 test and Sample Type Expansion
Te U.S. Food and Drug Administration (FDA) authorized the BioFire Defense COVID-19 test for emergency use on March 23, 2020. Te test provides a “detected” or “not detected” report about 50 minutes after a sample, collected via a nasopharyn- geal swab in transport medium, is loaded for analysis. Te test is performed on the BioFire FilmArray instrument, which is already present in many Department of Defense facilities.
“We are capitalizing on the work done by our colleagues at JPEO-CBRND [Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense] earlier this year, when they partnered with BioFire Defense to start the develop- ment of the COVID-19 test,” said Dr. Clifford Snyder, product manager for this effort within the WPAC PMO. “Tis test detects
48 Army AL&T Magazine Winter 2021 TEST CREATION
Tests currently in development by InBios International will be able to identify people infected with SARS-CoV-2. Each of these tests will provide results within 15 to 30 minutes of sample collection. (Image courtesy of InBios International)
SARS-CoV-2 nucleic acid with a high degree of specificity and sensitivity. Te virus can’t hide from this test.”
Te FDA’s emergency use authorization allows this test to be used, however, the 510(k) route to FDA clearance, which involves the acquisition of additional performance data, will provide addi- tional confidence in the accuracy of test results and support use of the test even after the COVID-19 emergency expires. Te WPAC group worked closely with USAMRAA to finalize BioFire Defense’s commitment to perform the required studies. On June 4, 2020, a $3.1 million contract was awarded to BioFire Defense, with completion expected by June 2021.
WPAC has also initiated work on expansion of the range of sample types for the COVID-19 test, in order to address chal- lenges associated with obtaining nasopharyngeal swab specimens, possible shortages of swabs and viral transport medium, and to examine whether the testing of additional sample types might
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