EL CENTRO — El Centro Regional Medical Center and the US Department of Health and Human Services (HHS) announced newer therapeutic treatments in a recent press conference aimed at helping high risk patients who have tested positive for COVID-19 at ECRMC.
Monoclonal antibody therapeutic treatments were first administered December 30 at ECRMC, making ECRMC the first in a pilot program to prevent hospitalization and the severity of illness in high-risk patients such as seniors 65 or older, immuno-compromised residents, and residents 55 years of age or older with major pulmonary diseases, high blood pressure, and other pre-existing health factors and co-morbidities, said Dr. Michael Anderson, consultant and senior advisor to the assistant secretary of Preparedness and Response through the HHS.
“Like many hospitals across the Country, (ECRMC) is caring for an extremely high number of patients who have developed severe cases of COVID-19,” Dr. Robert Kadlec, the HHS assistant secretary for Preparedness and Response, said in a press release.
“At this infusion center, a federal medical team will be on hand to provide therapeutic treatments that can keep people from becoming so sick that they need to be hospitalized,” he said, “which will help reduce the stress on the hospital, particularly the ICU, and help save lives.”
Anderson said while vaccines “are life-saving, and very important,” the COVID vaccines take months to “really have an impact on a city, region, and on the Country,” which is why the HHS and ECRMC are attempting to utilize the monoclonal antibody therapies “over the next several weeks.”
“Monoclonal antibodies are a therapy that attack and neutralize the COVID virus in patients,” he said. “In high-risk patients, we believe, that these therapies will decrease their need for hospitalization, and of course most important, help them get healthier faster.”
Both products can be used to treat adults and pediatric patients (12 years of age or older weighing at least 40 kilograms/88 pounds) who have positive test results and who are at high risk for progressing to severity, according to the press release.
Only high-risk patients who meet the criteria and are referred either by their physician or the ECRMC emergency room after testing positive for COVID-19, will be admitted to the Infusion Center, according to the release, as the therapies may not work for all COVID patients, Anderson said.
According to the release, “high risk” is defined as adults having met at least one of the following criteria: body mass index (BMI) of 35 or greater, chronic kidney disease, diabetes, immunosuppressive disease, currently receiving immunosuppressive treatment, or being 65 years of age or older. The FDA defines high risk differently for children.
Anderson said the treatments may not work on all COVID-19 positive patients and “we do not have enough evidence as to whether or not these therapies would be effective against that variant (found in the United Kingdom, New York, and Colorado) because it’s so rare.”
The Infusion Center — a military-looking alternative site tent which sits outside of ECRMC — will see these groups of patients within 10 days of their COVID-19 positive test and developing symptoms, Anderson said, to have these monoclonal antibody therapies administered intravenously.
Patients at the Infusion Center will receive one of two therapeutics. The treatments were authorized by the US Food and Drug Administration (FDA) and are either from Eli Lilly and Company, which uses the antibody bamlanivimab, or from Regeneron, which combines two monoclonal antibodies casirivimab and imdevimab. Both Eli Lilly and Regeneron treatments have been authorized for emergency use in the US since November, according to the release.
The medicines will be administered through an IV infusion treatment, which, when coupled with medical observation for up to an hour, will take approximately two-and-a-half hours in total.
“So, you'll come in, you'll be greeted, you'll have your blood pressure taken, your temperature taken, some screening questions,” said Gina Smith, nurse and team leader for the National Disaster Medical System, explaining the process.
“You'll be escorted over to one of our cots, and an IV will be put in your arm. You'll receive the IV fluid medication over one hour and then the medication will stop,” she said.
“We'll leave that little IV in while we observe you for an hour, which can be in a chair or relaxing in the cot, and then after an hour we'll talk with you (to) see how you're feeling, and if you're feeling good, you'll be sent home,” Smith said.
“Then the final thing before you leave (is) we'll take out that IV line, put a bandage on it, and then remind you if you have any symptoms or your symptoms worsen to contact your physician or come to the emergency department if you're unable to reach your physician.”
The extra hour of medical observation is a precaution to monitor potential side effects or potential allergic reactions, Smith and Anderson said, as some have been reported across the US but to a small margin, according to Anderson.
“They appear very safe,” he said. “Side effects are very rare; I think reported in less than 2 percent of patients. The most severe type of reaction — a severe allergic reaction — I think has only been reported less than five times (nationally) by my read.”
“(The observation is) a precaution that we take and that's why we have nurses, paramedics, and a safety officer all inside there, focusing on the care of the patient in all directions,” Smith said.
“Our hope is that we will prevent individuals from having to be hospitalized, therefore decompressing the hospitals once they receive these antibiotics so we can keep people out of the hospital and help take care of their symptoms at the beginning,” she said.
Anderson said the FDA has allowed the monoclonal treatments to be used “from time of onset of symptoms, to 10 days, so that’s why Dr. Edward said at the beginning: ‘We want to get people in early.’”
“Look, everything that we're going to have to do we're gonna have to do in terms of partnerships with everybody,” ECRMC CEO Dr. Adolphe Edward said during the press conference.
“We're happy and glad that the Department of Health and Human Services have actually stepped up to the leadership, and I know under the direction of Dr. Kadlec, Dr. Anderson and Gina, this is going to be a success,” he said.
“It's gonna help us fight the battle here in a community that has been decimated…adding a tool in our toolbox we call therapies to include the Infusion Center is going to be a win-win for the community,” Dr. Edward said. “We're so happy to join hands with the Department of HHS to actually provide that to our community.”
As of December 30, ECRMC had 165 patients in-house, 113 being COVID positive, Edward said.
Smith said the Infusion Tent has a 28-to-30 patient-per-day capacity and it will be open regularly from 9 a.m. to 7 p.m. at ECRMC.