Back to Top Skip to main content Skip to sub-navigation

Defending the Homeland: Turning on lifesaving trials at Madigan Army Medical Center

Image of soldier in front of a laptop 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)

Recommended Content:

Coronavirus

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.”

Disclaimer: Re-published content may be edited for length and clarity.  Read original post.

You also may be interested in...

It’s Not Over Yet: Some COVID Safety Precautions Remain Necessary

Article
7/22/2021
a crowd of people

Returning to society when fully vaccinated is great but keep that mask handy

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus

How COVID-19 fast-tracked innovation in the Military Health System

Article
7/20/2021
Military personnel receiving the COVID-19 test

As the COVID-19 pandemic disrupted every aspect of healthcare delivery, the Military Health System responded with new and innovative ways to fight the disease and deliver safe, quality care to patients.

Recommended Content:

Health Innovation Month | Innovation | COVID-19 Vaccine Toolkit | Coronavirus

COVID vaccinations rise -- but so do concerns of the Delta variant

Article
7/1/2021
Military personnel wearing a face mask preparing a COVID-19 vaccine

MHS expected to reach 70% COVID-10 vaccination rate in July.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | COVID-19 Vaccine Efforts

New COVID-19 Delta Variant: What You Need to Know to Stay Safe

Article
6/28/2021
Military personnel receiving the COVID-19 vaccine

COVID-19 Delta variant spreading rapidly; it’s time to get vaccinated

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | COVID-19 Vaccine Efforts | COVID-19 Delta Variant

Army’s 773rd administers mobile COVID-19 testing during DEF21

Article
6/4/2021
Three military personnel, wearing masks and lab coats, pose for a picture in an Albanian lab.

Approximately 800 Army Reserve soldiers from the U.S. and Europe participated in DEFENDER-Europe 21.

Recommended Content:

Health Readiness | Coronavirus | COVID-19 Vaccine Toolkit | Readiness Capabilities

Mental Health Panel Discusses Impact of COVID-19

Article
6/3/2021
Military personnel wearing face mask speaking on a panel

Walter Reed Bethesda hosts mental health panel to discuss the impacts of COVID-19.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | Psychological Fitness

Based on data, MHS experts encourage vaccines for adolescents

Article
6/1/2021
Sister and brother smiling at each other

With the Pfizer vaccine approved for youth ages 12 to 15, MHS adolescents are lining up to get the COVID-19 vaccine.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | COVID-19 Vaccine Efforts | Children's Health | Vaccine Eligibility

“Shots in arms” – OPT planned & coordinated to meet COVID-19 mission

Article
5/28/2021
Military personnel sitting around a table talking

The Department of Defense’s COVID-19 Operational Planning Team has been the quiet force behind the DOD’s vaccination effort since November.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus

Adolescents ages 12 and older eligible for COVID-19 vaccinations

Article
5/27/2021
Son of military personnel receiving his COVID-19 vaccine

Pfizer vaccine now authorized for children 12 and older.

Recommended Content:

Children's Health | COVID-19 Vaccine Toolkit | Coronavirus

COVID-19 Town Hall with RADM Anne M. Swap

Article
5/24/2021
MHS and Military OneSource NCR COVID-19 Town Hall with Rear Admiral Anne M. Swap, Director, National Capital Medical Directorate, Wednesday, May 26 at 11:50 a.m. ET

The purpose of this event is to inform National Capital Region (NCR) beneficiaries of DHA’s efforts with battling coronavirus (COVID-19) and encourage them to not delay care.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | COVID-19 Vaccine Efforts | MHS and Military OneSource To Your Health

Adirim, Place laud DHA response to COVID-19 in briefing

Article
5/21/2021
Defense Health Agency Director Lt. Gen. (Dr.) Ronald J. Place speaking at a press conference

Dr. Terry Adirim, acting assistant secretary of defense for health affairs, and Army Lt. Gen. (Dr.) Ronald J. Place, director of the Defense Health Agency, provided a COVID-19 update during a Pentagon press briefing.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus

Sailors continue to receive COVID-19 vaccine

Article
5/20/2021
Military personnel wearing a face mask receiving the COVID-19 vaccine

Sailors continue to voluntarily receive one of the three available COVID-19 vaccines.

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus | COVID-19 Vaccine Efforts

MHS quickly adapted to improve patient experience during pandemic

Article
5/19/2021
Military health personnel waiting for the next phone call on the COVID-19 advice line

MHS adapted technology to boost patient experience during pandemic

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus

DHA Director visits MCAGCC to hear from the ‘Boots on the Ground’

Article
5/19/2021
Military personnel wearing face masks walking

DHA Director visits Marine Corps Air Ground Combat Center Twentynine Palms.

Recommended Content:

MHS GENESIS | Military Health System Transformation | Coronavirus | COVID-19 Vaccine Toolkit

Palliative care provides comfort to COVID-19 patients, families

Article
5/17/2021
Military health personnel taking care of a patient

Medical Center team develops palliative care toolkit for COVID-19 patients

Recommended Content:

COVID-19 Vaccine Toolkit | Coronavirus
<< < 1 2 3 4 5  ... > >> 
Showing results 1 - 15 Page 1 of 25

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

Some documents are presented in Portable Document Format (PDF). A PDF reader is required for viewing. Download a PDF Reader or learn more about PDFs.