CCMC offers COVID-19 antibody therapies
PARKERSBURG – WVU Medicine Camden Clark Medical Center is now offering the two leading monoclonal antibody therapies in the treatment of COVID-19.
The U.S. Food and Drug Administration issued an emergency use authorization for the investigational monoclonal antibody therapies Bamlanivimab and Casirivimab/Imdevimab. These are in addition to the vaccines that have begun to be administered nationwide.
Dr. Walter Kerschl, vice president and Camden Clark’s chief medical officer, said the therapies have been out several months. President Donald Trump received one of the therapies in October after testing positive for COVID-19.
“There have not been full trials, but there has been a lot of data and a lot of testing that goes into this,” Kerschl said of the treatment’s emergency status.
“We got word that we were getting a shipment of this and we now have greater than 60 dosages.”
Once getting word the medications were coming, the hospital began putting together a plan that would, hopefully, produce a seamless process where eligible patients, recommended by their physicians, could receive the intravenous treatment through an infusion clinic at the hospital.
“We have done six in the last five weeks,” Kerschl said. “We have three we have done this (past) week.
“I think it is starting to pick up in terms of identifying patients that are appropriate for the infusion.”
The therapy is for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab and Casirivimab/Imdevimab is authorized for patients who tested positive who are 12 years of age and older weighing about 88 pounds, and who are at high risk for progressing to severe COVID-19 or hospitalization, according to information provided by Camden Clark. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
COVID-19 monoclonal antibody (mAb) therapies are neutralizing antibodies and can provide passive immunity to COVID-19. When given early after contracting COVID-19, ideally within the first few days of symptom onset, mAbs block entry of the virus into human cells by binding to the receptor binding domain on the spike protein of the virus.
In studies to date, mAb therapy has shown a possible benefit in reducing progression to severe disease and potentially the need for hospitalizations in high-risk patients, according to the information provided by Camden Clark.
In the beginning, Kerschl said the qualifications were very tight at first where patients had to be over 65 years old, have a positive COVID-19 test within eight days and having certain conditions.
“We were trying to identify the sickest of our population that could progress to hospitalization,” he said, adding that the whole premise behind this is to keep people out of the hospital.
“That is what we are trying to do.”
Now, if someone has a positive diagnosis of COVID with one mild or moderate symptom, 65 years old and above someone can qualify for the medication within 10 days of being tested, Kerschl said.
“I think the take-home message is that our older population which has a greater chance of being hospitalized, they qualify if they become positive with COVID and we want to get them in and infused,” he said.
People can also qualify if they are someone under 65 with a condition like diabetes, morbid obesity, immunosuppression or others if they are 18 years old or above.
There are also requirements for patients who are 12-17-years old, which include a positive COVID test and at least one mild/moderate symptom, including but not limited to loss of taste, loss of smell, headache, fever, fatigue and others as well as sickle cell disease, heart disease, neurodevelopmental disorders, asthma and more.
It all starts with the patient being checked by their doctor.
“If a patient thinks they are positive, they need to call their primary care office,” Kerschl said. “The office can then refer them to the clinic at Camden Clark, either over the telephone or through the electronic medical record, if they are on the Camden Clark system.”
A nurse practitioner makes sure the patient qualifies and meets the necessary criteria. They then schedule everything and set up an appointment.
The patient is then notified of their appointment and given instructions of where to go at the medical center, an alternative entrance which avoids the main entrances to the hospital. The patient will be escorted to the clinic.
They meet the nurse who is doing the infusion, get set up and registered. The IV is placed in them. The infusion lasts one hour, Kerschl said.
After that, the patient is monitored for an additional hour with health personnel looking for any side effects, including nausea, dizziness or diarrhea which Kerschl said were usually mild and occurs in the 3-4 percent range of patients.
“We always monitor them for any kind of allergic reaction to the medication,” he said.
Afterwards, the patient will be put in a wheelchair and escorted back to where their vehicle will be able to pick them up.
Afterward, there is cleaning and sterilizing done before the next patient comes in.
They keep track of how effective the treatment was for each patient watching for allergic reactions and so on to be reported to the FDA if needed as well as being kept track of by the hospital.
Right now, nothing is required to be reported back to the drug companies, Kerschl said.
Kelsie Gabbart, 71, received the treatment at Camden Clark on Dec. 15 and says he is now doing “great” as a result.
He was diagnosed with COVID and received the treatment after being recommended by his primary care doctor. He had an appointment set up and was told how to report in at the hospital and received the therapy. He was the first person in the area to receive the treatment at Camden Clark.
“I got along good with it,” he said.
He said medical personnel were regularly checking his vitals every 15 minutes for his first hour. An hour is spent administering the I.V. where medical personnel were continuing to check vitals. He was continually checked for another hour after getting the therapy. Since his blood pressure went up a little, they kept him an extra half-hour for monitoring.
“I never got sick from it,” Gabbart said. “I was really surprised by it.
“I figured I would have a lot of side effects from it, but I had nothing like that.”
Before being diagnosed he had a cough, watery eyes and a runny nose. He suffers from arthritis and said he had one day when that was really hurting.
“I felt like I had the flu,” Gabbart said. “They said the dip was to help prevent me from getting sicker.
“It boosted me right up. It helped me a lot.”
Pharmacist Michael L. Miller, was also diagnosed last month with COVID-19.
“One of the hardest parts of finding out you are COVID positive is accepting that fact,” he said. “I was so surprised by the positive test I could not think correctly.
“I quickly sent my physician. Dr. (Bairava) Kuppuswamy, a note on My WVU Chart and a nurse almost immediately replied that I needed to leave work ASAP, go home then call the office and set up a virtual appointment.”
He did the virtual appointment and worked with his doctor to get things set up for the therapy.
“As a pharmacist, I was aware of Bamlanivimab and that the FDA was allowing the infusion under an emergency use authorization — which means it was not yet an FDA approved therapy,” Miller said.
His doctor worked quickly and realized that being over 55 with comorbidities (a disease or medical condition that is simultaneously present with another or others in a patient) would make him a candidate for the infusion.
He heard back from the hospital and had an appointment set up for the following day and received the treatment on Dec. 17.
“I was advised this was about a three-hour process from start to finish,” Miller said.
He arrived at the hospital and was escorted to the clinic by security and a nurse. After arriving in his room in the COVID unit, a nurse practitioner came in and started the process.
“She was the nicest, kindest and most professional nurse she could have been,” Miller said.
“She stayed by my side for the entire three hours and kept me well informed of everything going on — I can honestly say I was scared to death as I had no idea how I might react to the therapy.”
Once complete he was escorted back out to his vehicle.
“At that point I did not feel any different even though I had read about patients who almost immediately showed signs of improvement,” Miller said. “The next day was Friday and I can say that day did not go well either, it seemed nothing changed.”
He spoke to a representative of the Mid-Ohio Valley Health Department and they explained the quarantine process.
“I found out if I did not get worse, my last day in quarantine would be Dec. 25,” Miller said. “The next day was Saturday. Amazingly when I woke up my cough and sinuses had improved, the total body aches and chills improved and I felt I was getting better.
“Over the next week all of my symptoms improved, except for loss of smell (which eventually returned) and being tired which continues. I have nothing to compare to the way I felt but the miraculous turnaround was amazing to me.”
Miller was thankful to Kuppuswamy and his entire staff for their quick response. He was able to leave quarantine on Dec. 25 and return to work on Dec. 28.
“Words cannot describe how lucky I felt to put this behind me,” he said. “I do want to let people know that it is important to contact your Primary Care Physician immediately if you test positive for COVID.
“To be able to go from feeling miserable and scared to improving that quickly is incredible. It is an amazing therapy. I was lucky as a dear friend of mine passed recently from the same disease which is tragic.”
He is recommending people get vaccinated.
“Having gone through the disease process it is not something anyone would want or wish on someone,” Miller said. “Again, I am thankful for Dr. Kuppuswamy, his staff and the staff and pharmacy at Camden Clark for getting me the monoclonal antibody therapy and helping me heal so quickly.”
Hospital officials are now wanting to get the word out about the monoclonal antibody therapies.
“We have been educating all of our doctors,” Kerschl said, adding he has been sending out regular briefings to their doctors.
They are also having regular meetings, making refinements and other improvements in the process.
“Many hospitals across the country are suffering from over-capacity,” Kerschl said. “We have to do something.”
Even with treatments and vaccines, doctors are still urging people to wear masks, social distance from other people, wash their hands continually, don’t have big parties and more.
“If we can do that over the next 100 days it is going to help,” Kerschl said. “It will make it so we are not stressing out all of our frontline providers, our doctors, our nurses, our techs that is going to help. This therapy will also help because if we can identify and keep people out of the hospital that will be great.”
Camden Clark is still working on its vaccination efforts for hospital personnel. Their health professionals within the center are expected to have been given the vaccine within the next couple of weeks.
“We are excited,” Kerschl said.
As far as people getting the vaccine in relation to this therapy, doctors know that the infusion can affect the vaccines ability to create an immune response.
“Therefore it is recommended to have enough time in between these two treatments, maybe up to three months,” Kerschl said. “If you become COVID positive and participate in the infusion therapy, you reduce your risk of severe progression of the virus and the need to be hospitalized.”
Again, Kerschl advises patients to check with their primary physician to see if they qualify for the monoclonal antibody therapy.
Other hospitals in the area are also doing the therapy. Memorial Health System has the therapy available at its Belpre Campus.
Kerschl said doctors want to be sure this treatment can get to those who need it, if that is Camden Clark or elsewhere.
“If you qualify, we want to see you and get this medication in you,” he said. “There is a specific timeframe of 10 days from the time you were tested.
“Time is of the essence.”