Turning on lifesaving trials at Madigan Army Medical Center

Janell Cain, a clinical research coordinator at Madigan with the Infectious Disease Clinical Research Program, records the informed consent forms signed by a patient receiving treatment for COVID-19 in the intensive care unit from Madigan’s Virtual Critical Care Center on April 14. Communicating with the patient and nurses via the video equipment, Cain gains the necessary consent to enroll a patient in a study of remdesivir as a COVID-19 treatment without expending personal protective equipment, or exposing anyone to the patient unnecessarily. The IDCRP is a Department of Defense-wide research consortium headquartered at the Uniformed Services University for the Health Sciences in Bethesda, Md. (Lt. Col. (Dr.) Christopher Colombo)

MADIGAN ARMY MEDICAL CENTER, Joint Base Lewis-McChord, Wash. – Madigan Army Medical Center, on Joint Base Lewis-McChord, Wash., has been a hotbed for biomedical research for years, highlighted by patented innovations and award winning presentations at national and international scientific meetings.

In response to the COVID-19 global pandemic, Madigan is currently supporting nine research protocols designed to address gaps in knowledge including clinical characteristics of the COVID-19 illness, the impact of nutrition on COVID-19 risk, and the clinical value of convalescent plasma, in which a patient with severe disease is given plasma from someone who has recovered from COVID-19 and therefore has antibodies to it in their blood, to name a few.

Possibly the most notable clinical trial for COVID-19 treatment involves remdesivir, an investigational, broad-spectrum antiviral drug that has shown some promise, in animal trials, in both Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.

The trial is sponsored by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, and is the first clinical trial in the U.S. to evaluate an experimental treatment for COVID-19.

When the trial began in February, Dr. Anthony Fauci, the director of NIAID and a member of the U.S. Coronavirus Task Force said, “We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes. A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Madigan is one of 68 international trial sites among 47 in the U.S. and 21 in Europe and Asia. The first enrollee was at the University of Nebraska Medical Center/Nebraska Medicine, in February; he had been on a cruise ship that saw a number of infections.

The initiation of the trial can is described here: https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-treat-covid-19-begins.

Within two months of initiation, the clinical trial of remdesivir has produced encouraging results.

In a statement issued on April 29, the NIAID reported, “Preliminary results indicate that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0 percent for the group receiving remdesivir versus 11.6 percent for the placebo group (p=0.059).”

This trial is managed at Madigan by the Infectious Disease Clinical Research Program, a Department of Defense-wide research consortium headquartered at the Uniformed Services University for the Health Sciences in Bethesda, Md. The IDCRP conducts clinical research that focuses on reducing the impact of infectious diseases relevant to the DoD.

For more information about the IDCRP, visit: https://www.idcrp.org/about-us.

The IDCRP has a broad research portfolio, including an ongoing study looking at the efficacy of different formulations of the flu vaccine. When COVID-19 emerged, the IDCRP pivoted to get this research up and running in a very short period of time. As an established IDCRP site, Madigan was identified as one of the military treatment facilities eligible for participation in the NIAID trial.

“Because they are so active and such a squared-away group, they were able to help get this trial off the ground,” said Lt. Col. (Dr.) Christopher Colombo, principal investigator for the COVID-19 trial and the director of Virtual Health and Telecritical Care at Madigan.

Madigan has strong and adaptive biomedical research capabilities that are facilitated by its Department of Clinical Investigation.

“The Department of Clinical Investigation, Dr. Rick Burney (DCI’s chief) and Dr. (Silvija) Salai (the human subject protection administrator), have been fantastic in supporting and expediting this and balancing making sure that everything is still done dress-right-dress according to regulatory, safety and scientific integrity filings, but it is going quite a bit faster than usual, because of the situation that we're in,” noted Lt. Col. Colombo.

Madigan is one of five DoD sites that has enrolled patients in the study so far and is already ramping up for its next phase. Investigators stress that these are early days of evaluation for this trial. Given the high transmissibility and global spread of this virus, research has moved quickly.

“It's a placebo controlled trial, so the patients are randomized. We don't know who's getting what. They either get placebo or remdesivir,” Lt. Col. Colombo said.

NIH requirements for inclusion in the trial comprise the need for hospitalization for documented COVID-19 infection and either an abnormal chest x-ray or the requirement for supplemental oxygen or mechanical ventilation. Trial participation is limited to adults.

Participants in the treatment group get 200 milligrams (mg) of remdesivir injected on the first day they are in the study and 100 mg each day of their hospitalization, up to 10 days total. Those in the placebo group receive the same amount of what looks like remdesivir but contains only inactive ingredients.

This means the trial is administered to patients currently being treated in the hospital, though some have since improved and gone home. They return to the hospital periodically for monitoring.

Dr. Rhonda Colombo, an infectious diseases physician who works in support of the IDCRP at Madigan, praised the contributions of patients who volunteered to participate in this and other ongoing clinical research trials.

“Without willing and engaged study participants, clinical research is not possible. At Madigan, we are incredibly fortunate to be part of a community that values clinical research. Our research team is humbled by the generosity and commitment of the people who volunteer to participate in our studies,” said Dr. Colombo.

With drug safety and long-term effects always in mind, the team is not yet ready to draw conclusions, but is optimistic about the data so far.

Susan Chambers, the clinical operations manager for the IDCRP at Madigan echoed that appreciation for the high value that Madigan, and the JBLM community place on research, noting that it is the providers and nurses on the inpatient units who directly support research within their care of patients.

“We are incredibly proud to have the opportunity to offer access to cutting-edge research for our Active Duty personnel and DoD beneficiaries. Our success would not be possible without the support of Madigan Commander Col. Thomas Bundt and the committed inpatient clinical care teams at Madigan,” said Chambers.

On Friday, May 1, the U.S. Food and Drug Administration gave remdesivir emergency use authorization to treat COVID-19.

The NIAID expects to share additional data soon, as well as next steps.

“We managed to get meaningful research turned on, very quickly. Other sites in the Department of Defense, are kind of looking at Madigan like you guys are knocking it out of the park, keep going,” said Lt. Col. Colombo. “I think it's something that's cool in terms of how we're responding to COVID in a positive way and making some good come of this.”

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