There’s a race underway to find meaningful therapies that reduce the threat posed by the pandemic, because evidence-based treatment would make the disease caused by the novel coronavirus more survivable and less of a risk to society.
While the FDA has taken some emergency steps to remove some red tape to getting started, testing the science behind medicines and vaccines will take time.
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“This is a terrible disease. We want the answers as quickly as yesterday. But you cannot get good answers without doing good studies. And good studies do take some time,” said Dr. Glen Solomon, chairman of the department of internal medicine at Wright State University’s Boonshoft School of Medicine.
Solomon, who is not part of the Soliris study, said the clinical trial process the researchers are going through is the right approach and it’s important to be careful about hype behind drugs before research behind different therapies is further along.
There’s no treatment for COVID-19 yet proven effective in a clinical trial.
However, several dozen possible vaccines are under development, and dozens of trials are underway to investigate whether any experimental or existing medications can be re-purposed to treat COVID-19 patients.
One of those drugs is Soliris, the drug administered to De Vos, who was hospitalized in March with COVID-19 at Premier Health’s Upper Valley Medical Center.
Soliris, made by Boston-based Alexion Pharmaceuticals, has been FDA-approved since 2007 for treatment of immune response problems associated with several rare conditions.
The experiment going on now is to see whether Soliris’ properties mean that it can be re-purposed to save patients who get so sick from COVID-19 that their own immune response to the coronavirus gets disproportionate and causes sometimes fatal damage to their body.
“So we’re talking about a relatively small group of people in the COVID population. But within this group, you have an 86 to 97% mortality rate,” said Dr. Thomas Pitts, director of neurology at Hudson Medical in New York, also with Premier Health’s tele-neurology program.
The idea of re-using Soliris for this purpose comes from Pitts, who already uses Soliris to respond to this problematic immune response with other diseases.
The drug is not available at your regular retail pharmacy, since according to the drug information its risk of infection places it in a risk management program where only a health care provider can administer it. Under the typical circumstances that the drug is designed for (not the experimental COVID-19 therapy being tested), GoodRx estimates the annual cost for Soliris for a course of therapy at $678,392. In this trial, Alexion has provided the medication and the patient and facility do not have to bear the cost of the medication.
De Vos is now recovering and was discharged from the hospital last week. She said when she came to after being intubated for 16 days “people started coming to see me and they were so excited to see me and I had no idea why.”
“And then I started hearing what happened and realizing the extent of everything I went through, and realized that I did receive that miracle life of a lifetime,” she said. She still has PT and OT to work on recovery and has some short term memory loss.
Patients had been so far signed up for the study on a case-by-case basis. The study of the drug is what’s called a proof of concept study, which is now closed to other patients while results are pending. The FDA found the results successful enough to approve an expanded access trial that will be a rolled out protocol at specific institutions.