A treatment called REGEN-COV has been recently administered as an infusion or injection in an outpatient setting at the hospital, intended to reduce the risk of death in COVID-19 patients.
While there are no hospitalized patients currently receiving the therapy at Habersham Medical Center, CEO Tyler Williams said the treatment has been used in the hospital and has proven to be effective.
According to hospital officials, REGEN-COV reduced the risk of individuals with a known exposure to COVID-19 from developing a symptomatic COVID-19 infection by 92 percent in the phase three clinical trial.
Furthermore, it prevented symptomatic and asymptomatic infections overall by 66 percent. Finally, individuals with symptomatic infections resolved two weeks quicker than individuals who did not receive the injection.
Studies on the treatment explain how it works.
According to the website precisionvaccinations.com, “Regeneron’s REGEN-COV Monoclonal Antibody Cocktail (Ronapreve) combines monoclonal antibodies casirivimab and imdevimab, explicitly designed to block the infectivity of SARS-CoV-2, the coronavirus that causes COVID-19. This was the first antibody therapy to demonstrate an anti-viral effect in patients hospitalized with COVID-19.”
“Regeneron’s core technologies allow for the rapid and efficient generation of these protective anti-viral antibodies outside of the body, derived from genetically humanized mice or convalescent humans,” the study adds. “The resulting antibodies correspond to the most potent anti-viral antibodies that could be elicited by a vaccine or through exposure to a pathogen. The REGEN-COV antibodies can be delivered to people via injection, providing ‘passive immunity’ and immediately protecting the disease. However, they must be re-administered to remain effective over time. These antibodies can also treat an existing infection, unlike vaccines, which can only be used preventatively.”
Asked about the treatment, Vice President of Culture and Wellness Executive of HMC Kesha Clinkscale cited the New England Journal of Medicine, which states: “Symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5 percent) and in 59 of 752 participants in the placebo group (7.8 percent) (relative risk reduction [1 minus the relative risk], 81.4 percent; P<0.001).
In weeks 2-4, two of the 753 participants in the REGEN-COV group (0.3 percent) and 27 of 752 participants in the placebo group (3.6 percent) had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6 percent). REGEN-COV also prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4 percent).
Among symptomatic infected participants, the median time to resolution of symptoms was 2 weeks shorter with REGEN-COV than with placebo (1.2 weeks and 3.2 weeks, respectively), and the duration of a high viral load (>104 copies per milliliter) was shorter (0.4 weeks and 1.3 weeks, respectively). No dose-limiting toxic effects of REGEN-COV were noted.”
According to Clinkscale, REGEN-COV, produced by the company Regeneron and distributed to hospitals through various suppliers, the available supply of the life-saving treatment fluctuates.
“As with any new drug or therapeutic that treats a COVID-19 infection, supplies can vary depending on how actively the Coronavirus is spreading in an area,” Clinkscale said. “At times when the Coronavirus is spreading very rapidly and there are a large number of patients with a COVID-19 infection, supplies can be limited. Currently, it is very difficult for hospitals to get a resupply of REGEN-COV.”
REGEN-COV is only approved for patients that have mild to moderate symptoms therefore only for outpatients. It is also administered to Emergency Room (ER) patients who qualify.
“The FDA has specific guidelines as to who is eligible to receive the REGEN-COV antibody therapy,” Clinkscale added. “This treatment must be ordered by a physician, therefore, the physician must make sure the patient meets the specifications set forth in the FDA usage guidelines. Habersham Medical Center works with patients and physician offices to get this treatment scheduled as an outpatient visit. We are not having to prioritize who receives the drug as long as the patient falls within the FDA guidelines as it is our intent not to over-schedule the supplies that we have on hand. We are also actively working to order more.”