A medical worker administers a free Covid-19 test at a state drive-through test site in the parking lot of the University of Texas, El Paso campus on November 23, in El Paso, Texas amid the coronavirus disease (COVID-19) outbreak , 2020.
Ivan Pierre Aguirre | Reuters
Al Weiss, 74, entered New York’s Mt. Sinai Hospital earlier this month for a colonoscopy and went out with a diagnosis of Covid-19.
Within days, he said, he was receiving treatment with Covid-19 monoclonal antibodies from Eli Lilly as part of a clinical study investigating possible side effects of drug infusion. Within 72 hours, his mild symptoms, including fatigue and a 101-degree fever, subsided and “I was Superman,” Weiss said in a telephone interview.
“I firmly believe it was an advantage,” he said. “It was better than sliced bread.”
Monoclonal antibody treatments such as those made by Weiss and one made by Regeneron that were given to President Donald Trump have shown promising signs of fighting the disease when given early in infection. But the drugs are not widely used by the general public. A lack of staff to deliver the drugs that need to be administered via IVs, as well as delays in Covid-19 tests, have limited their use, according to hospital administrators and public health professionals.
Marta Wosinska, deputy director of the Duke Margolis Center for Health Policy, said at an event held by the National Academies of Science, Engineering and Medicine last week that the value of antibody treatments has “a certain level of uncertainty”. The only available data on treatments are from small clinical trials.
The Infectious Diseases Society of America has recommended bamlanivimab against the routine use of Eli Lilly’s treatment in the absence of data. And the National Institutes of Health cited “insufficient data” saying the drug “should not be considered a standard of care”.
Wosinska said this was a problem because treatment was not easy. Hospitals need to set up an infusion center and staff only for Covid-19 patients to effectively distribute the drugs and separate them from cancer and dialysis patients. But there is “discomfort from providers as to whether it is really worth setting up a whole new system for the delivery of these drugs,” said Wosinska.
Many hospitals across the country are already facing extreme stress and the lack of data makes it difficult for hospitals to justify an investment in treatment. Still, the drugs show promise when given “to the right patient, at the right time, in the right place,” she added.
One of the main difficulties with antibody treatments is that they seem to have the greatest benefit when given early to patients, Wosinska said.
“We have to infuse this drug within seven days of symptoms appearing, but patients generally don’t seek treatment until they are quite ill,” she said. “We have told patients that if you are not really sick, don’t come to the emergency room. Stay home, take care of yourself, isolate. And here we really want to register patients very early.”
And there are logistical delays that keep patients from getting a quick infusion as well. Before anyone even considers receiving treatment, they must do a Covid-19 test and get the results back. This can take a day or more depending on where the sample is taken.
Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health System Pharmacists, said delays in testing limit the “window to the infusion”.
“The first challenge is that the locations where the drug is infused may not be the same place where Covid tests are done,” he said at the National Academies event, adding that people in particular are in rural communities may have difficulty moving from a testing center to an infusion center. “The other thing is the challenges with test capacity and test lead time.”
Michael Wargo, vice president of emergency preparedness at HCA Healthcare, said he is working on integrating testing centers more closely with hospital systems so that individuals eligible for treatment with antibodies can be notified shortly after diagnosis.
“We need to develop these inclusion criteria at the time of testing,” he said. “When they go in and are checked for risk for Covid, we check them for inclusion criteria. Let’s build that and even work with big lab systems like Quest Diagnostics.”
In addition to testing, Wargo reiterated that shipping to infusion centers is one of the major obstacles to using the antibody treatments. He said HCA is experimenting with a number of initiatives to expand access, including “reversing the process of donating blood”.
Patients eligible for the treatments would be extremely contagious, so asking them to take public transport to an IV center is not ideal. According to Wargo, HCA has considered working with organizations like the American Red Cross to convert their blood donation vehicles into mobile infusion centers.
Other hospital systems are exploring the possibility of home IVs, said Mark Jarrett, chief quality officer at Northwell Health. However, he added that home infusions are extremely labor intensive and many hospitals just don’t have their hands free right now.
“This is the perfect personnel storm,” he said. “We have a wave of illnesses in the hospitals … we now need a lot of staff for the vaccination … infusion staff themselves come from the nursing pool, so that’s a problem.”
“This is a resource that we need to reach our patients. It will take the burden off the hospitals, but the devil is in the details,” he added.
Awareness of the treatments is another problem, Jarrett said. Lots of people don’t know this is likely an option for them if they are at high risk and start showing symptoms early, he said.
“We are dealing with the issue of public advertising,” he said. “We were very reluctant to do this at the beginning because we feared we might exceed our offer. At this point we really believe we can adjust to it.”
However, he noted that some people are reluctant to receive treatment because it has only been approved by the Food and Drug Administration in an emergency and there isn’t much data to vouch for its safety and effectiveness.
Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, reiterated Jarrett’s concern about the lack of awareness. He added that public health has been so focused on the Covid-19 vaccines that not much effort has been made to educate the public about monoclonal antibody treatments.
“Public health is not really in a position right now to advocate anything other than a vaccine. It is a big endeavor and that is where their attention is,” he said. “But I think the problem is that antibody treatments have just disappeared from the radar screens.”