Mayo Clinic scientists find themselves at the front lines in the global fight against Covid-19

In the early 1940s, with the world at war, Mayo Clinic made the decision to defer most of its ongoing research activities to instead focus on the war effort. The work included conducting investigations into treatments that could be used in battle; hosting 3-month training courses for hundreds of medical officers; and, later, fielding medical units in the Pacific Theater.

But it was the work done in a newly-formed aero-medical unit that would go on to produce the greatest legacy. Research into what caused pilots to black-out while accelerating at high altitudes led Mayo scientists to develop the G-suit, along with an in-flight oxygen mask. Both creations were used in the war and later credited for helping the Allies claim victory.

Today, Mayo finds itself in a similar position, with a nation looking to the Rochester-based institution for life-saving answers and innovations.

This time the enemy is invisible — knowing no borders, carrying no guns or grenades — though the dire situation warrants a response rivaling what took place here during World War II. As of this report, Covid-19, the disease caused by the novel coronavirus, has claimed the lives of at least 188,000 people around the globe. In the U.S., the death toll has surpassed 40,000.

At Mayo and other medical organizations, the pandemic has led to considerable challenges as hospitals put off elective procedures to free up personnel, space and resources for patients battling Covid-19. As a result, many essential health care workers are being asked to make sacrifices, both in terms of their wallets and their health.

But much like it did 80 years ago, Mayo, as an institution, has responded aggressively to the government’s call for a rapid response to defeat the coronavirus. In a matter of weeks, Mayo has mobilized its entire operation to take on the virus, while making critical investments in research, and participating in leadership roles at the local, state and federal levels.

The Clinic is now conducting at least seven clinical trials into potential treatment options; leading a national trial into the use of convalescent plasma to treat patients hospitalized with Covid-19; leveraging artificial intelligence to predict virus hot spots; studying health disparities among various populations; exploring paths toward a vaccine; and processing thousands of samples a day using serological and molecular tests.

“I don’t think it’s an exaggeration to say that if you can think of it, somebody [at Mayo] is doing it,” said Dr. Andrew Badley, an infectious disease specialist and chair of Mayo’s Covid-19 Research Task Force.

An ‘unheard of’ sense of urgency

In the clinical trial space, Mayo is pursuing two broad categories of treatments: one class of drugs that would modify the immune response and/or inflammation when a patient is infected, potentially helping prevent them from getting sicker, and another set aimed at stopping the virus from being replicated, known as antivirals.

BioSig Technologies, a Connecticut-based company with an office in Rochester, is among the companies partnering with Mayo to accelerate investigations into antivirals. The company announced it would soon be partnering with Mayo on a Phase II FDA clinical trial into Vicromax. The drug, according to BioSig CEO Ken Londoner, has demonstrated to decrease viral production of Covid-19 by over 98 percent in lab testing.

In an interview this week, Londoner said his goal now is to get the first set of data by June, with Stage III trials potentially beginning in July. From there, if the data affirms the drug’s effectiveness, the company will look to begin ramping up production to get the treatment into patients as quickly as possible. Already, in anticipation of FDA approval, Londoner said BioSig has begun lining up a chemical supply and manufacturing capacity.

“The quicker we can move along, and I am not saying we have the only solution, but everybody knows therapeutics come before vaccines — so to get a therapeutic treatment out broadly to communities in the fall would at least allow our people to start coming out of the cocooning phase in their homes, and depending on the efficacy of the drug, they may be able to get back to more of a normal lifestyle,” said BioSig CEO Ken Londoner.

Dr. Andrew Badley, an infectious disease specialist and chair of Mayo’s Covid-19 Research Task Force, is the physician leading the trials into Vicromax, along with other potential treatments. He said it is premature to make conclusions on which drugs work and which ones don’t, noting that “clinical trials are done for a reason.”

However, his optimism is driven by the pace at which things are now moving. Before the outbreak, he said, there were hurdles to collaboration between biopharma and research centers like Mayo. Now, given the critical need to develop therapies, those hurdles have largely been broken down.

“Now, conversations begin within hours, rather than weeks or months,” said Badley. “And there is a lot of back and forth, and teams are working together, and different centers are offering their unique areas of expertise to create a synergy of activities — all toward the shared goal of getting on top of this disease.”

Londoner said collaborations like the one BioSig has with Mayo will be crucial to getting new Covid-19 drugs to market. He described the sense of urgency being acted upon at Mayo and elsewhere as unprecedented.

“We have been [working with] Mayo since 2014, and Mayo’s a phenomenal place … but I have never seen Mayo move like the way they are now,” said Londoner. “And I was actually told, ‘don’t get used to this.’ Because it’s sort of the right place, right time … It’s just unheard of, but totally necessary.”

Putting country first

For Mayo, the work being done now has ramifications well beyond Rochester. With the country at a standstill, Mayo has become one of the foremost institutions the federal government is calling on for guidance — a point underscored by Thursday’s news that Vice President Mike Pence, head of the nation’s coronavirus task force, will visit town next week to learn more about the Clinic’s testing and research efforts.

In recent weeks, the most powerful testimony to Mayo’s commitment to public service — which dates back to the days of W.W. Mayo — has been the institution’s role in leading the Convalescent Plasma Expanded Access Program, a national initiative to treat patients with cases of Covid-19.

So far, despite financial setbacks of its own, the Clinic has invested at least one million dollars — a number anticipated to continue growing — into the program, which involves 1,633 hospitals and acute care facilities.

“[Mayo CEO Dr. Gianrico Farrugia] and our leadership team are so committed to making this a possibility for the United States that they have said, ‘we’ll do this as our contribution to the country, regardless’,” said Dr. Scott Wright, a Mayo Clinic cardiologist and clinical researcher.

In addition to bridge therapies — like the antibody-rich convalescent plasma treatment, which as of Monday had been administered to 750 U.S. patients — scientists at Mayo are also conducting investigations into what would be the Holy Grail in the fight against Covid-19 — a vaccine.

Badley said Mayo researchers are now working on a number of attempts to create a vaccine for the virus, though none are at the state of being ready to go into humans. Additionally, Mayo has been in discussions with other companies, such as Massachusetts-based Moderna, that are proposing vaccines of their own. Moderna’s vaccine is already being tested in humans, with the goal of reaching a limited volume of people by the fall.

Short of a major breakthrough, however, experts generally agree a vaccine will not be ready for widespread distribution for at least a year. In the meantime, states such as Minnesota are looking at ways to bulk up testing, which would allow for more careful monitoring of the outbreak.

Just this week, Gov. Tim Walz announced plans to coordinate with Mayo and the University of Minnesota to establish a capacity for delivering 20,000 molecular and 15,000 serology tests a day. The testing program would be the most advanced in the nation, potentially providing a model for others areas looking to navigate through the pandemic.

Sean Baker is a Rochester journalist and the founder of Med City Beat.

Cover photo licensed through Getty