Many doses of the antibody drugs that treat mild to moderate COVID-19 are sitting unused around the country. There are logistical problems with providing these drugs and skepticism over whether or not they work. But two major health systems have had success in deploying these medications, and they are reporting hopeful results.
Monoclonal antibodies, manufactured by Regeneron and Eli Lilly, are available since just before Thanksgiving. The Food and Drug Administration authorized them for emergency use after studies suggested that they reduced the danger of hospitalization among people at elevated risk. That includes people over 65 and people with underlying health conditions like obesity.
The drugs are antibodies engineered to bind to the coronavirus so they can't enter human cells. President Trump received a dose of the Regeneron product before it had been authorized for emergency use and his administration bought quite 1,000,000 doses to distribute to hospitals around the country.
COVID-19 Spark Hopes.
But uptake has been spotty, partly due to the difficulties of administering it. People eligible for the drug have active infections, so it is vital to treat them without exposing other patients. And each treatment, by infusion, takes an hour, followed by a minimum of another hour of observation, which process requires staff time within the midst of an epidemic surge.
"When you add all this up, it's a logistical challenge to deliver this therapy to a lot of people,” says Dr. Howard Huang, at Houston Methodist Hospital. Nominally the hospital's medical director of lung transplantation, he has been a part of an attempt to beat those challenges. He says one strategy has been to open clinics around Houston. Doctors affiliated with the hospital are encouraged to spot and refer eligible patients for treatment.
"Now we're doing about 50 to 70 infusions each day," he says. There has been a push to treat people as quickly as possible after infection. "From the time they call in to being infused, it's always but two days."
That timing is vital because albeit patients are eligible for treatment within 10 days of their first COVID-19 symptoms, the drugs appear to be simpler early within the course of the disease.
And while medication sits unused in many locations across the country, Huang says that's not the case at his hospital.
"Right now, we're constrained more by the drug supply." The federal has allocated 32,000 doses of antibody medicine to the state of Texas so far, and it's up to state officials how to distribute them. Huang says Houston Methodist uses its allocation as fast because it gets it.
Many doctors nationwide aren't so hooked on these drugs, though. Treatment guidelines issued by the National Institutes of Health say there's no good evidence to understand whether or not they work. That's because the Food and Drug Administration relied on studies of just a couple of hundred patients to grant emergency authorization.
"These are very small numbers that, under normal conditions, nobody would ever publish during a journal just like the New England Journal of drugs," Huang says. "But yet this is headline news. Welcome to COVID time, right?"
But doctors are gaining experience. Houston Methodist has treated quite 1,100 patients as of Jan. 4, Huang says.
"We're seeing results that are like the clinical trials by Eli Lilly and Regeneron," he says. About 6% or 7% of patients who are treated find themselves within the hospital or ER. Based on the sooner studies, he suspects 15% of the foremost at-risk patients, if untreated, would have ended up within the ER or a single bed.
COVID-19 testing using RT-PCR Technology.
Doctors affiliated with the Mayo Clinic also are encouraged by their experience. As of Jan. 5, they had dosed quite 2,000 patients, in Minnesota, Wisconsin, Arizona, and Florida.
Dr. Raymund Razonable at Mayo says the clinic, headquartered in Rochester, Minn., had been involved in clinical trials of those antibodies so was attuned to their potential benefit. The staff started planning the way to administer it well before the drugs were available, he says. One strategy was to maneuver some medical practices out of their spaces so that they might be repurposed expressly as infusion centers for COVID-19 patients.
Razonable has done a preliminary analysis of the primary 1,018 patients, and he also finds less than expected hospitalization rates.
"More importantly there's some signal that it's also reducing death," he says, "But again, these are preliminary analyses. We have to form sure this is often all vetted by the referee. But this is what we're seeing. That's why we're happy."
Unlike a clinical test, this real-world experience doesn't have a randomized comparison group, so doctors can't say needless to say that these patients are faring better. The NIH treatment advisory committee, which is currently ambivalent about the worth of those drugs, will evaluate new data because it comes in, so it could revisit its recommendations when the Mayo results become available.
These encouraging findings could also be swaying doctors who weren't sure they wanted to refer their patients for treatment. Razonable says patients are also becoming less skeptical.
"Initially there have been more 'declines' than 'accepts,' but now we're seeing more 'accepts' than 'declines' " he says.
And albeit it takes tons of person-power to supply this treatment, Razonable and Huang believe they're reducing the general workload, by keeping patients out of the hospital. Moreover, the use of medical products is encouraged such as medical masks, disposable gloves, and protective coveralls to ensure the patients are safe even without hospitals.