From the frontlines of COVID-19 clinical trials

May 18, 2020

Providence News Team

Ever since that fateful January day earlier this year, when the first known coronavirus (COVID-19) patient was admitted to one of our hospitals in Everett, WA, the experts at Providence have been on the forefront of treating this newly discovered disease.

As we work our way through the initial stages of the COVID-19 pandemic, we’re expanding our efforts by designing and participating in leading-edge clinical research and studies to help develop a vaccine, find ways to treat it and learn more about it through antibody testing.

“We are operating some of the largest clinical trials in the country for drug therapies and antibody testing. We’re also doing genomics research to understand why the virus affects some people more than others.”

“We are operating some of the largest clinical trials in the country for drug therapies and antibody testing. We’re also doing genomics research to understand why the virus affects some people more than others,” said Rod Hochman, M.D., President and CEO of Providence in a recent blog.

Here’s a look at some of the highlights.

Using past cancer research to develop a vaccine to prevent COVID-19

This information was sourced from a Talk with a Doc episode with Dr. Rom Leidner, a medical oncologist, on April 22, 2020. Listen here.

Researchers at the Earl A. Chiles Research Institute at Providence’s Robert W. Franz Cancer Center in Oregon are taking the knowledge they’ve gained studying cancer immunotherapy and applying it to COVID-19. The team has applied to the Food and Drug Administration to conduct a vaccine trial that uses parts of the COVID-19 virus against itself.

“The virus is decorated with all these little red spikes. This is the protein that latches on to human cells, which makes it more difficult for the immune system to see. This is the target for the vaccine we’re pursuing,” said Medical Oncologist, Dr. Rom Leidner in a recent Talk with a Doc episode.

The plan calls for injecting volunteers with disabled DNA from parts of the virus. That makes the human immune system recognize and prepare for an attack. A second injection gives the immune system a boost to help it fight off the infection it can now see.

The trial will be open to adults in good health who have not been infected with COVID-19. Once approved by the FDA, the trial is expected to begin within 60 days.

In a standard research setting, this process would take months of planning and preparation. But the experts at Providence understand this is not a standard situation and they’ve reacted accordingly, developing a proposal in only 12 days. “We’ve broken all of our own records. It’s been really an inspiring thing to see,” said Dr. Leidner.

Contributions from generous donors are making the work possible. “One of the reasons we’re able to move so quickly is it’s all supported by philanthropy. We didn’t have to hesitate to start this process. And that’s been a key part of this,” said Dr. Leidner.

“All the years and decades of training have led up to this moment to do whatever we can to stop the virus. What we’re all concerned about is whether we’ll have an effective vaccine. There are so many different approaches going on right now, so we’ll have a lot of data to tell us what works.”

“We made a conscious decision that business as usual was not appropriate. We have started the manufacturing process in parallel, so the minute we have a green light from the FDA we are not delayed waiting weeks and weeks to make enough to start the trial,” said Dr. Leidner. “All the years and decades of training have led up to this moment to do whatever we can to stop the virus. What we’re all concerned about is whether we’ll have an effective vaccine. There are so many different approaches going on right now, so we’ll have a lot of data to tell us what works.”

Clinical trials test treatment options for safety and effectiveness

Information about Providence’s participation in clinical trials was sourced through the U.S. National Library of Medicine.

We understand that finding an effective, safe treatment for COVID-19 is critical.

Providence is participating in several ongoing studies of remdesivir, which was originally developed by the Gilead company to treat Ebola and aims to kill certain viruses and keep them from replicating themselves.

Our doctors have used remdesivir to treat COVID-19 symptoms, but further studies are needed to completely assess whether the treatment is both safe and effective on a larger scale.

On April 29, 2020, Gilead announced initial results from their Phase 3 remdesivir trial that evaluated 5-day and 10-day dosing durations for hospitalized patients with advanced manifestations of COVID-19. Learn more here.

We are currently participating in trials sponsored by the National Institute of Allergy and Infectious Diseases and Gilead Sciences to examine the drug’s effectiveness against COVID-19. Providence is also a part of several smaller studies looking at various treatment options, including arthritis medication, Kevzara and malaria treatment hydroxychloroquine.

Antibody testing key to learning how COVID-19 affects the body

This information was sourced from a Talk with a Doc episode with Dr. Rom Leidner, a medical oncologist, on April 22, 2020. Listen here.

Although you’ve probably heard about antibody testing in the news, you may not understand why it’s important. Antibody testing is a key component in understanding COVID-19 and developing effective strategies for prevention and treatment. It helps gauge how many people have been infected, how many were asymptomatic and how many were never diagnosed. Antibody testing is different than diagnostic testing, which determines whether COVID-19 is currently active in your body. Antibody testing examines your body’s immune response to the virus.

Antibody testing is different than diagnostic testing, which determines whether COVID-19 is currently active in your body. Antibody testing examines your body’s immune response to the virus.

The number of fake or unproven antibody tests on the market continues to rise. Since the pandemic began, multiple firms and manufacturers are claiming falsely that their tests are FDA approved or authorized. Providence is one of the few organizations working on a legitimate testing option seeking full FDA approval.

With record speed, experts at Providence designed and launched a voluntary study that examines hospital workers who are on the frontlines of treating the disease to better understand the body’s response to COVID-19. The study tracks caregivers at Providence with biweekly testing intended to identify people who have been infected with COVID-19 and then developed an immune response.

“As we know, there are many people who get coronavirus that don’t get many symptoms, or actually, don’t get any symptoms. Their immune system has a memory of [the infection] and that’s what we’re testing for in the antibodies. We’re not testing to see if you have the virus in your blood—that’s the swab test. We’re testing if your immune system has ever seen this virus,” said Dr. Leidner in a recent Talk with a Doc episode.

Researchers will use participants’ blood samples, which will be screened for antibodies. Testing will continue every two weeks for several months.

“There will be some percentage of health workers that have the antibody. These are the healthy workers. We’re seeking to learn how effective immune response works. What did their immune system do when they did get exposed? What does it look like when the immune system does get infected? These insights will help us understand what type of vaccine is needed to fight the virus,” said Dr. Leidner.

Examining the science behind the disease

This information was sourced from a Facebook Live event with Dr. Rod Hochman and Dr. Jim Heath, held Tuesday, April 21, 2020. Listen here.

Swedish Medical Center recently launched a unique study with the Institute for Systems Biology (ISB) and Merck that will follow patients who contracted COVID-19 to determine why different patients have vastly different reactions, ranging from no symptoms to death, after exposure to the virus.

Researchers will collect blood samples at three different stages of illness, starting with diagnosis. They intend to look closely at components of the patients’ DNA to learn how the virus evolves and what that means for prevention and treatment.

ISB President, Dr. Jim Heath, who is co-leading the study, spoke with Dr. Hochman in a recent Facebook Live about some of the science that goes into antibody research and the unique challenges caused by COVID-19.

“What a vaccine is intended to do, is to expose the patient’s immune system to an innocent form of the virus so that you learn about what that virus looks like without it having the potential to kill you. There are a lot of ways to do that.”

“One problem people are probably struggling with is: there are all of these drugs you hear about. Why is it so hard to figure out if they work? Normally, if you’re going to do a clinical trial you select your set of patients—let’s just make an analogy with a track meet—you put them all at the starting point, you shoot the gun and then hopefully the ones that got the drug cross the finish line faster, they perform better and that’s your trial. This is the exact opposite of that,” he explained. “We have people who are starting at all positions on the track. We don’t really know where. All we know is that they all cross the finish line at some point.”

Antibody testing can help develop a vaccine by showing your body’s response to the virus. “What a vaccine is intended to do, is to expose the patient’s immune system to an innocent form of the virus so that you learn about what that virus looks like without it having the potential to kill you. There are a lot of ways to do that,” said Dr. Heath.

“We have a lot of observations right now of some patients who have done really well and some haven’t. We don’t really have the quantitative evidence to really understand them. I think we’re getting to that,” he said.

Not only is antibody testing a vital part of treatment development, it’s also a key component of ensuring the public’s safety to end social distancing and quarantine requirements.

Hope for the future

This information was sourced from a Facebook Live event with Dr. Rod Hochman and Dr. Jim Heath held Tuesday, April 21, 2020. Listen here.

Not only is antibody testing a vital part of treatment development, it’s also a key component of ensuring the public’s safety to end social distancing and quarantine requirements, which further emphasizes the importance of our many research efforts.

"If we had the test now, we could identify people that could go back to work right now. And I think that’s really the heart of trying to get things started back in a safe way."

“Every municipality, state government, federal government is trying to figure out, ‘how do you open things up?’” said Dr. Hochman. The answer according to Dr. Heath? Testing.

“I strongly support this notion of testing. If we had the test now, we could identify people that could go back to work right now. And I think that’s really the heart of trying to get things started back in a safe way. I know people are frustrated. We’ve got to get back to our lives, right? But you also don’t want to take the virus home and infect your family. I think testing is central to us being able to go back and open up our economy,” said Dr. Heath. “The antibody testing is the missing ingredient right now.”

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