Imagine taking a pill that – even if you’re not vaccinated and even if someone you share space with has COVID-19 – would protect you from the coronavirus.
As one of 43 sites around the country in a clinical trial, a Mesa center is a key player in what many are dreaming about: The hypothetical “COVID pill.”
Arizona Clinical Trials is looking for people who live with someone who has COVID-19 and want to be – potentially, at least – part of history.
In a modest south-central Mesa office surrounded by insurance, weight loss and arthritis treatment providers, Dr. Anita Kohli meets potential volunteers to discuss a trial she hopes will be groundbreaking.
“As an individual citizen, I’m rooting for it like you wouldn’t believe,” said the upbeat, energetic Kohli. “As a scientist, I am always cautious, just look at the data.”
But when she sets her “just the facts” professional microscope aside, for the moment, she steps back to view a big picture that is almost staggering.
“We hope for all of humanity this works,” she said. “We hope to develop a simpler drug that can be in every pharmacy in America. And the world.”
Last year, Kohli and Arizona Clinical Trials took part in a crucial trial that found Regeneron to be an effective treatment for COVID-19.
According to the New England Journal of Medicine, Regeneron’s “combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among high-risk persons with coronavirus disease 2019 (COVID-19).”
The Regeneron “cocktail,” according to the medical journal, “prevented symptomatic COVID-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.”
Though joyous over the positive clinical results that paved the way for FDA fast-tracking of Regeneron, Kohli and others have been frustrated over its limited use.
Then-President Donald Trump, after being diagnosed with COVID and having his oxygen levels drop to dangerous levels, received the Regeneron “cocktail” that he credited for his stunning bounce-back to good health.
Nine months later, according to a recent Washington Post story, “Monoclonal antibodies are free to patients and there have been almost no side effects…But Regeneron Pharmaceuticals, maker of the only authorized, free monoclonal antibodies, said it is reaching fewer than 30 percent of eligible patients, up from fewer than 5 percent a month ago.”
As the Post article notes, Regeneron is administered via infusions at hospitals, urgent-care centers and some other medical facilities.
That’s the problem, noted Kohli, a Delaware native who trained under Dr. Anthony Fauci – now the leading spokesman on COVID, as the director of the National Institute of Allergy and Infectious Diseases before moving to Gilbert six years ago.
“We’ve been running clinical trials for the treatment of COVID for around a year; we started July 1, 2020,” she said.
After three phases of monoclonal antibodies testing, she was pleased to see Regeneron’s path to being widely available. While she said the effectiveness of the drug is not challenged, “the biggest question is, ‘Is there a way to simplify treatment?’ Instead of intravenous therapy, if we could develop a pill.”
Enter the new trial for molnupiravir, launched two weeks ago.
Volunteers who live with someone with COVID will get doses of either the molnupiravir pill or a placebo, with results from both groups tabulated to see how effective molnupiravir is.
The trial lasts 29 days, with the first five days of four pills taken every 12 hours, followed by a tracking period to report symptoms.
The trial is only open to those who have not been vaccinated against COVID-19.
“We have not enrolled anyone yet,” Kohli said Monday.
While this trial excludes those who currently have COVID-19, Kohli noted Arizona Clinical Trials has several studies going on, including treatments for those with active COVID.
“People are looking for options and solutions,” she said. “We hope to help the community.”
“We have to use what we know works. Right now, we do have a great (COVID treatment) option, people should utilize it more.”
Regeneron’s approval was, in a small way, assisted by the trials Kohli and company did in Mesa.
The national effort behind that trial “shows how well we can push this field forward and really bring incredible, innovative and cutting edge (treatment) in a year.”
But, again, she is pained by the idea that the treatment is still relatively limited.
“Some of these deaths are absolutely avoidable,” she said.
Monoclonal antibody treatment is a narrow window: It works best when someone is sick with COVID, but not to the point where the patient is hospitalized with respiratory distress and other conditions caused by the disease.
Regeneron, she said, “reduces hospitalization and death (from COVID). We need to be more aggressive about treating people before they get that sick. We have to give it to people early in their disease.”
“I did not get COVID. We take a lot of precautions to keep our staff safe,” the doctor added. “I commend my team all the time. They worked with COVID from the very beginning; they worked side by side with people with COVID.”
For those who are not able to avoid COVID, Kohli said: “Call us early in your disease. We’re happy to talk through options.”
Arizona Clinical Trials is also known as Arizona Liver Health, and provides free scanning for fatty liver disease (which 1 in 3 Americans have).
For information, call 480-360-4000 or visit azclinicaltrials.com.