A medical staff administers a free Covid-19 test at a state-run testing site in the parking lot of the University of Texas El Paso campus amid coronavirus disease (COVID-19) in El Paso, Texas, November 23, 2020.
Ivan Pierre Aguirre | Reuters
Al Weiss walked into New York City’s Mount Sinai hospital earlier this month for a colonoscopy and went out with a Covid-19 diagnosis.
But within days, the 74-year-old Weiss said he was given Eli Lilly‘s Covid-19 monoclonal antibody therapy as part of a clinical trial investigating potential side effects of the drug infusion. Within 72 hours, his mild symptoms, including fatigue and 101-degree fever, subsided, and “I was Superman,” Weiss said in a phone interview.
“I definitely think it was beneficial,” he said. “It was better than sliced bread.”
Monoclonal antibody treatments such as the one Weiss took and another produced by Regeneron it was given to the president Donald Trump have shown promising signs of fighting the disease if given early in the infection. But the drugs are not widely used by the public. A shortage of staff able to administer the drugs to be given via IV drip, combined with delays in the Covid-19 test has limited their use, hospital administrators and public health specialists said.
There is “a level of uncertainty” about the value of antibody treatments, said Marta Wosinska, deputy director at the Duke-Margolis Center for Health Policy, speaking last week at an event hosted by the National Academies of Sciences, Engineering and Medicine . The only available data on the treatments come from small clinical trials.
Infectious Diseases Society of America has recommended against routine use of Eli Lilly’s treatment of bamlanivimab with reference to lack of data. And the National Institutes of Health, citing “insufficient data,” said the drug “should not be considered a standard of care.”
Wosinska said this is a problem because they are not easy treatments to administer. Hospitals need to dedicate an infusion center and staff so that Covid patients effectively dispense the drugs and keep them separate from cancer and dialysis patients. But there is “concern from providers about whether it is really worthwhile to set up a whole new system for the delivery of these drugs,” Wosinska said.
Many hospitals across the country are already under extreme stress, she noted, and given the lack of data, it is difficult for hospitals to justify investing in treatment. Still, the drugs have shown a great level of lift when applied to “the right patient at the right time in the right place,” she added.
One of the biggest difficulties with antibody treatments is that they seem to have the greatest benefit when given early to patients, Wosinska said.
“We need to infuse this drug within seven days of the symptoms, but patients generally do not seek care until they are quite ill,” she said. “We’ve told patients that if you’re not really sick, do not come to ER. Stay home, take care of yourself, isolate yourself. And here we will actually catch patients really early.”
And there are logistical delays that keep patients from a quick infusion. Before people consider getting the treatment, they have to apply for Covid test and get the results back, which can take a day or longer, depending on where the sample is collected.
Michael Ganio, senior director of pharmaceutical practice and quality at the American Society of Health-System Pharmacists, said test delays limit “the window to infusion.”
“The first challenge is that the sites that infuse the drug may not be the same site that performs Covid testing,” he said at the National Academies event, adding that rural people in particular may struggle to walk away from a test center for an infusion center. “The other thing is the challenges of test capacity and test time.”
Michael Wargo, Vice President of Emergency Preparedness at HCA Healthcaresaid he is working to integrate test centers more closely with hospital systems so that people eligible to receive antibody treatments can be notified shortly after diagnosis.
“We need to develop these inclusion criteria at the test point,” he said. “Once they go in and they are screened for risk for Covid, let’s screen them for the inclusion criteria. Let’s build it and even collaborate with the big lab systems like e.g. Quest Diagnostics. “
In addition to testing, Wargo reiterated that transport to infusion centers is one of the biggest barriers to the use of antibody treatments. He said the HCA was experimenting with a number of initiatives to expand access, including “reversing the process of blood donation.”
Patients eligible for the treatments would be extremely contagious, so it is not ideal to ask them to travel by public transport to an infusion center. Wargo said the HCA has considered collaborating with organizations like the U.S. Red Cross to convert their blood donation cars into mobile infusion centers.
Other hospital systems are looking at the possibility of conducting home infusions, says Dr. Mark Jarrett, Quality Manager at Northwell Health. However, he added that home infusions are extremely labor intensive and many hospitals just do not have the free hands right now.
“This is the perfect storm for staffing problems,” he said. “We have a wave of illness in the hospitals … We now need lots of staff for vaccination … The infusion staff themselves come from the nursing pool and that is therefore a problem.”
“This is a resource we need to get our patients. It will ease the burden on the hospitals, but the devil is in the details,” he added.
Awareness of the treatments is another issue, Jarrett said. Many people do not know that if they are at high risk and early in symptom onset, this is probably an option for them, he said.
“We are investigating the issue of public advertising,” he said. “We were very hesitant to do that at first because we were afraid we would exceed our supply. At this point, we really think we might be able to make it.”
However, he noted that some people are reluctant to get the treatment because it is only approved by the Food and Drug Administration in an emergency and there is not a lot of data that can guarantee its safety and effectiveness.
Dr. Marcus Plescia, chief physician at the Association of State and Territorial Health Officials, reiterated Jarrett’s concern about the lack of awareness. He added that the public health community has been so focused on the Covid-19 vaccines that little has been done to educate the public about monoclonal antibody treatments.
“Public health is not really capable right now of being a champion of much more than a vaccine. It’s a huge task and this is where their attention is,” he said. “But I think the problem is that the antibody treatments have just gone off the radar screens.”