Can you get the same experimental treatment as Trump if you get coronavirus? At least you can ask

By JoNel Aleccia - NBC News

Terry Mutter woke up with a headache and aching muscles.

Since he likes to lift weights, he attributed it to hard training.

But at night he had a fever of 101 degrees Fahrenheit and was clearly ill.

remembers Mutter, who lives near Seattle, Washington. 

The next day, Thursday, he was diagnosed with COVID-19.

On Saturday, the 58-year-old was already enrolled in a clinical trial to receive the same antibody cocktail that President Donald Trump said had been his "cure" for the coronavirus.

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"I had heard a little bit about this on the news," said Mutter, who joined drugmaker Regeneron's study to test whether their combination of two artificial antibodies can neutralize the deadly virus.

"I think they probably treated him with everything they had," he added.

Mutter learned about the study from his sister-in-law, who works at the Fred Hutchinson Cancer Research Center in Seattle, one of the nation's testing medical institutes.

Now the man is among hundreds of thousands of Americans, including the president, who took risks with experimental therapies to treat or prevent COVID-19.

But with nearly eight million people infected and more than 217,000 deaths attributed to the coronavirus in the United States,

many patients are unaware of these options or cannot access them.

Others are wary of unproven treatments ranging from medications to vaccines.

"I honestly don't know if I would have gotten a call if I hadn't met someone who said, 'Hey, here's this study,'" said Mutter, a retired executive at Boeing.

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The clinicaltrials.gov website, which reviews that research, has reported

.

More than 430,000 people have volunteered for those studies through the COVID-19 Prevention Network.

Thousands more have received therapies, such as the antiviral drug remdesivir, under emergency federal authorization.   

Faced with a serious coronavirus diagnosis, how do patients or their families know if they can, or should, seek these treatments?

And how can they decide whether to turn them down when they are offered?

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These medical decisions are never easy, and they are even more difficult during a pandemic, said Annette Totten, a professor at Oregon Health and Science University.

"The challenge is that the evidence is not good because everything related to COVID is new,"

said Totten, who specializes in medical decision-making processes.

"I think it's hard to ignore all the noise," he added. 

Consumers are understandably affected by conflicting information about possible COVID treatments from political leaders, including Trump, and the scientific community.

The antimalarial drug hydroxychloroquine, touted by the president, received an emergency authorization from the Federal Food and Drug Administration, but was revoked several weeks later for fear that it could cause harm.

Convalescent plasma, which uses blood products from people recovered from COVID-19 to treat those who are still sick, has been administered to more than 100,000 patients in a wide 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 applied for an emergency use authorization for their monoclonal antibody therapies, although scientists say that approval could jeopardize enrollment in randomized controlled trials that will test whether or how well they work.

So far, about 2,500 people have signed up for Regeneron's trials, and about 2,000 of them are receiving the therapy, a company spokesperson said.

Others have received the treatment through compassionate use programs, although the company did not say how many.

This week, the National Institutes of Health halted Lilly's antibody assay after an independent monitoring board raised safety concerns.

"With all the information swarming in the media, it is difficult for patients, and physicians, to make good decisions," said Benjamin Rome, general internist and health policy researcher at Harvard Medical School's Portal program.

"You should not think that what you hear on the news is the right treatment for you," he added.

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Despite this, people with COVID-19 should not be afraid to question whether they have available treatment options, Rome said.

"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 on safety, while the phase 2 and 3 trials determine efficacy.

Any experimental treatment raises the possibility of serious side effects.

In an ideal situation, healthcare providers provide that information about the risks of treatments without warning.

But during a pandemic, especially in a high-stress environment, that may not happen, Totten said.

“It is important to be insistent,” he said,

.

Patients and families should take notes or record conversations that can be analyzed later.

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.

“What are the pros and cons?” Fagerlin said, “what would their decision be if they repent?

Not doing something and getting sicker?

Or do something and have a really negative reaction?

One consideration may be the benefit to society at large, not just you, he said.

For Mutter, helping the advancement of science was a great reason for agreeing to enroll in Regeneron's essay.

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"What interested me the most is that for science to advance you need people," he

said.

"At a time when there are so many things that we cannot control, this would be a way to get some kind of solution."

That decision led him to the Fred Hutchinson Center, which is collaborating on two Regeneron tests, one for the prevention of COVID-19 and the other for the treatment of the disease.

“It was a six-hour visit,” he said, “it's two hours to get the infusion.

It's a very slow IV drip. "

Mutter was the second person enrolled in the trial, said Shelly Karuna, a co-lead investigator on the project.

The study is testing high and low doses of the monoclonal antibody cocktail, compared to a placebo.

"I am amazed at 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 careful about masks and social distancing, and they have criticized those who have not followed the rules.

"The irony is that we were the ones who got sick,"

said Mutter, whose wife, Gina Mutter, 54, is also ill.

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 did not sign up for the test.

“This carries some risks.

I will sacrifice for the team, but I don't think we should both do that, ”he said.

So far, Mutter suffers from a cough and persistent fatigue.

You can't tell if your infusion has been helpful, or if it's a cure.

"

said, "did I have them and did that keep me out of harm's way or did they give me the placebo and my own immune system did its job?"