When Terry Mutter woke up with a headache and sore muscles, the amateur powerlifter attributed it to hard training.
However, that Wednesday night he had a fever of 101 degrees and was clearly ill. “It felt like I had been hit by a truck,” remembers Mutter, who lives near Seattle.
The next day he was diagnosed with COVID-19. On Saturday, the 58-year-old was enrolled in a clinical trial for the same antibody cocktail that President Donald Trump claimed had “cured” him of the coronavirus.
“I had heard it on the news,” said Mutter, who joined the Regeneron lab trial to test whether their combination of two artificial antibodies can neutralize the deadly virus.
Mutter learned about the study from his sister-in-law, who works at the Fred Hutchinson Cancer Research Center in Seattle, one of many trial sites across the country. He is one of hundreds of thousands of Americans, including the president, who took risks with experimental therapies to treat or prevent COVID-19.
But with nearly 8 million people infected and more than 217,000 deaths from COVID-19 in the country, many patients are unaware of these options or cannot access them. Others are wary of unproven treatments.
“I honestly think I would never have gotten a call if I hadn’t met someone who would tell me about the trial,” said Mutter, a retired Boeing executive.
The Clinicaltrials.gov website records more than 3,600 studies involving COVID-19 or SARS-CoV-2, the virus that causes the disease.
More than 430,000 people have volunteered through the COVID-19 Prevention Network. Thousands more have received therapies, such as the antiviral drug remdesivir, which has an emergency federal clearance.
Faced with a serious diagnosis of COVID-19, how do patients or their families know if they can, or should, aggressively seek these treatments? On the contrary, how can they decide whether or not to reject them if they are offered them?
Such medical decisions are never easy, and they are even more difficult during a pandemic, said Annette Totten, associate professor of medical informatics and clinical epidemiology at Oregon Health and Sciences University.
“The challenge is that the evidence is not good because everything with COVID is new,” said Totten, who specializes in medical decision making.
Consumers are understandably affected by conflicting information about possible treatments for LA COVID-19 from political leaders, including Trump, and the scientific community.
The drug hydroxychloroquine, touted by the president, received an emergency clearance from the Food and Drug Administration (FDA), only for the decision to be reversed several weeks later for fear that it would cause harm.
Convalescent plasma, which uses blood products from people recovered from COVID-19 to treat those who are still ill, was administered to more than 100,000 patients in an expanded access program and made available to all through another emergency authorization. , although scientists are not sure of its benefits.
Regeneron and the pharmaceutical company Eli Lilly have applied for emergency use authorization for their monoclonal antibody therapies, even as scientists say this could jeopardize enrollment in trials that will test whether or how well they work.
So far, about 2,500 people have signed up for Regeneron’s trials, and of those, about 2,000 are receiving the therapy, a company spokesperson said. Others have received the treatment through so-called compassionate use programs, although the company did not say how many.
The week of October 12, the National Institutes of Health halted Lilly’s antibody test after an independent monitoring board raised safety concerns.
“With all the information circulating in the media, it is difficult for patients to make good decisions, and for doctors to make those decisions,” said Dr. Benjamin Rome, internist and health policy researcher at the Portal de la Escuela de Harvard Medicine.
Still, people facing COVID-19 shouldn’t be afraid to ask if they have available treatment options, Rome added. “As a doctor, I don’t care when patients ask,” he said.
Patients and families need to understand what the implications of those treatments might be, Totten advised. The first phase 1 clinical trials focus primarily on safety, while the larger phase 2 and phase 3 trials determine efficacy. Any experimental treatment raises the possibility of serious side effects.
Ideally, health care providers would provide the information on treatments and risks without prior notice. But during a pandemic, and especially in a high-stress environment, they may not, Totten observed.
“It is important to be insistent,” he said. “And ask again. Sometimes you have to be willing to be a little aggressive, ”he suggested.
Patients and families should take notes or record conversations for later review. They should ask about financial compensation for participating. Many patients in COVID-19 trials are paid modest amounts for their time and travel.
And they should think about how any treatment fits into their broader system of values and goals, said Angie Fagerlin, a professor and chair of the department of population health sciences at the University of Utah.
THE ADVANCE OF SCIENCE
“What are the pros and cons?” Fagerlin wondered. One consideration may be the benefit to society at large, not just the patient, he said.
For Mutter, helping advance science was a big reason why he agreed to enroll in Regeneron’s essay.
“I was interested in advancing therapy, they need people,” he said. “At a time when there are so many things that we cannot control, this would be a way to find some kind of solution.”
This is what prompted Fred Hutch, who is participating in two Regeneron trials, one for the prevention of COVID-19 and one for the treatment of the disease.
“It was a six-hour visit,” he said. “It is two hours to receive the infusion. It’s a very slow IV drip. “
Mutter was the second person enrolled in Fred Hutch’s trial, said Dr. Shelly Karuna, co-principal investigator. The study is testing high and low doses of the monoclonal antibody cocktail against a placebo.
“I am struck by the profound altruism of the people we are evaluating,” he said.
Mutter is not sure how he contracted COVID-19. He and his family have been wary of masks and social distancing, and have criticized others for not.
“The irony now is that we were the ones who got sick,” said Mutter, whose wife, Gina Mutter, 54, also has COVID-19.
Mutter knows he has a 1 in 3 chance of receiving a placebo instead of one of two doses of active treatment, but he said he was willing to take that risk. His wife, also infected, did not sign up.
“I said, there are some risks involved. One of us can take the risk, not both of us, ”he said.
So far, Mutter has battled a persistent cough and fatigue. You can’t tell if your infusion has been helpful.
“There is just no way to know if I have the antibodies or not,” he said. “Did I get them and did that keep me out of the mess? Or did I have the placebo and my own immune system did its job?”