As another surge of COVID-19 infections began to develop in Northeast and Central Wisconsin in the fall of 2021, ThedaCare went into action to help community members diagnosed with the virus through Monoclonal antibody treatments.
Monoclonal antibodies (mAbs) can help prevent or reduce hospitalization, reduce viral loads and lessen the severity of COVID-19 symptoms. The Federal Drug Administration (FDA) gave emergency use authorization (EUA) to mAbs for the treatment of COVID-19 patients at high risk of developing a serious infection.
“Monoclonal antibodies are effective when given early in the course of infection,” said Montgomery Elmer, MD, Interim Medical Director of Primary Care for ThedaCare. “The current treatments available need to be administered within seven days of the onset of symptoms, so getting diagnosed early is important.”
Monoclonal antibodies are artificially produced proteins created to attack specific disease cells, thereby increasing a person’s immunity to the disease. According to the National Institute of Health, the first approved use of mAbs was in 1986 to prevent kidney transplant rejection. The FDA currently approves about 30 mAbs for various clinical uses.
After the FDA issued the EUA for mAb treatments for COVID-19, Dr. Mark Cockley, ThedaCare’s Chief Clinical Officer, challenged the ThedaCare staff to develop a protocol to provide the treatment. Dr. Elmer recalled Dr. Cockley saying, “We need to do this. Let us know what barriers you run into; then let’s figure out how to make these treatments happen.”
As the late summer surge of COVID-19 infections began, ThedaCare appointed a steering committee to ramp up treatments. They went to work to set up the initial mAb treatment program.
“The dedication from team members throughout the system, and support from our leadership team, were key factors in the success of providing mAb treatments to our communities,” said Hollar, who organized the administration of treatments at multiple ThedaCare facilities. “We followed the science and the data for mAb treatments. We had shown that we were helping prevent serious illness that would require hospitalization for some patients. We were also seeing those patients recover more quickly. Those were clear benefits from offering these treatments to community members.”
Hollar said it was also important to offer the treatments in various locations, making it accessible for more people.
“We understand that for some patients, transportation can be a barrier,” she said. “To avoid patients traveling long distances when they were not feeling well, we knew we needed to meet patients where they were testing positive, and treat them there.”
ThedaCare offers monoclonal antibody treatments to patients that have been evaluated by a health care provider and determined to meet qualifications. ThedaCare is not accepting home test results as qualifying for treatment. Currently, Sotrovimab is the only mAb treatment effective against the Omicron variant, and it is only given intravenously. After either treatment, the patient must remain at the medical facility for one hour for observation of possible side effects.
As of Feb. 2, ThedaCare had administered nearly 4,700 mAb treatments.
Dr. Elmer noted the timing to administer mAb treatments is important.
“It is critical that patients with risk factors for severe disease, immunocompromised patients, those who are unvaccinated or those who are not fully vaccinated with chronic conditions such as diabetes, obesity, high blood pressure, COPD, etc. be tested as soon as possible, within the first seven days of symptom onset,” said Dr. Elmer. “We understand for the best possible outcomes, those first seven days after symptoms appear, are a critical time to help reduce the risk of hospitalization and lesson the severity of symptoms through this treatment.”
Ruben Garza, a former patient of Dr. Elmer, received a mAb treatment in October 2021. He developed a fever and scratchy throat while at work one day. His fever quickly shot up to between 102-103 degrees, and he battled the fever for two days. Garza recalled on the second day, he developed aches and pains and his wife, a pharmacy technician, suggested he get tested for COVID-19. It came back negative.
But Garza couldn’t break his fever and missed two more days of work.
“On Saturday, I went to an urgent care clinic thinking maybe I had strep throat, but the strep test was negative so the doctor decided to retest for COVID, and that result was positive,” he said. “They reviewed my medical history and said because of my asthma, I was a candidate for the monoclonal antibody treatment. They explained it to me and my wife, and gave us some information to review.”
Garza had not been vaccinated against COVID-19 and said he had had reservations about the mAb treatment.
“My wife asked her pharmacy colleagues to review the information, and they said it was a good choice to receive the treatment,” said Garza. “Then when I found out Dr. Elmer was leading the mAb program, that also helped me feel comfortable with my decision to receive the treatment.”
Garza received the mAb infusion the following Monday, which was seven days after his symptoms began. By Wednesday, his fever started to break, and by Friday, he recalled feeling much better.
“I still had some shortness of breath, which was likely due to my asthma issues,” he said. “My sense of taste came back about a week after the infusion. But my sense of smell didn’t return until mid-November.”
Garza noted that after 90 days had passed following his mAb treatment, he would be vaccinated against COVID-19.
“We do want people to understand that mAb treatments cannot be used in lieu of the vaccine because the vaccine is believed to provide longer protection than the mAbs,” said Dr. Elmer. “Getting vaccinated is still the most important step toward preventing COVID-19. We also recommend precautions such as wearing masks, practicing social distancing and avoiding large indoor gatherings when COVID numbers are high in your area.”
Hollar noted that ThedaCare looks ahead to the future, continuing to offer these treatments to those diagnosed with COVID.
“We are grateful for the team members who helped create this program when our communities needed it most,” she said. “I believe it is a testament to the dedication and commitment they have to providing accessible care, helping patients get back to living their unique, best lives.”
