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Ad Hoc Treatment Team Develops COVID Guidelines

September 20, 2022
by Mary Ann Littell

In March 2020, Maricar Malinis, MD, FACP, FIDSA, FAST, and a group of colleagues were called to an emergency meeting. COVID-19 was on the horizon, and no one knew what to expect. The anxiety was palpable. The date itself was inauspicious: Friday the 13th.

“People from infectious diseases and other disciplines came together in a series of meetings to discuss how to formulate a treatment strategy for COVID,” says Malinis, associate professor of medicine (infectious diseases) and surgery (transplant), and medical director, Transplant and Oncology Infectious Diseases, Section of Infectious Diseases. “Our training prepared us for this. Infectious diseases can easily spread, aided by globalization and climate change. A pandemic like this was bound to happen. But as a clinician, you pray that it never does.”

From these meetings, a multidisciplinary team took shape, a collaboration between Yale School of Medicine (YSM) and Yale New Haven Health (YNHHS). The YSM/YNHHS Ad Hoc Treatment Group includes specialists in infectious disease, pulmonary and critical care, allergy/immunology/rheumatology, hematology/oncology, OB/GYN, and pharmacy. The team, led by Malinis, is comprised of some 15 clinicians, researchers, and pharmacists. (That number has fluctuated, depending on team members’ availability.)

“The ad hoc team recognized the need to provide consistent treatment recommendations for COVID inpatients when we had little to no data to go on,” notes Jeffrey Topal, MD, associate clinical professor of medicine (infectious diseases). As the director for antimicrobial stewardship at Yale New Haven Hospital (YNHH), he was keenly aware that having a consistent message on COVID therapy would be critical in managing a rapidly rising number of cases.

A specialist in transplant infectious disease, Malinis manages a small subset of patients with highly specific needs. But now she found herself leading a project with potentially huge impact. Explaining her transition from transplant ID to COVID-19, she says, “Regardless of our niche or specialization, the approach we took was, ‘All hands-on deck.’ This was our way to assist our clinicians who were directly taking care of COVID-19 patients.”

As COVID patients began arriving at area hospitals, the ad hoc team met daily, even multiple times a day, via Zoom to do their research. “Evaluating information about potential treatments, we familiarized ourselves with new clinical data, reading the literature and analyzing studies,” says Charles Dela Cruz, MD, PhD, associate professor of medicine (pulmonary, critical care, and sleep medicine), and of microbial pathogenesis; and director, Center for Pulmonary Infection Research and Treatment. “We discussed the studies’ strengths, reviewed guidelines from the Centers for Disease Control and Prevention, National Institutes of Health, World Health Organization, and other institutions nationally and internationally.”

The treatment team tapped other sources of information, initiating conversations with colleagues and academic health centers across the country. “Our work at time of limited information involved interaction with other clinicians and scientists to gain understanding of the disease process,” says Malinis.

The team also learned from the experiences of Yale Medicine’s own hospitalists and ICU physicians. All this data and information was synthesized into the treatment algorithm. “Implementing COVID treatment guidelines early in the pandemic, with frequent updates to conform to best evidence, enabled the medical team to provide a standardized approach to COVID care,” notes Dela Cruz.

To date, the algorithm has gone through some 25 iterations, based on clinical data, local clinical experience, and expert opinion. The first wave of potential therapies—repurposed antiviral and anti-inflammatory medications—were quickly deemed ineffective. The algorithm was ultimately refined to a standard of care that includes remdesivir, dexamethasone, and tocilizumab.

Yale was among the early adopters of tocilizumab, a game-changer in COVID care. This medication has long been used to reduce hyperinflammation in cancer patients undergoing immunotherapy. The same sort of reaction, known as ‘cytokine storm,’ develops in many patients with severe COVID-19, causing respiratory failure, clotting, and other serious complications.

“When it became clear that COVID-19 could result in cytokine storm, we had to devise therapies that addressed this complication,” says Topal. Several members of the treatment team were familiar with the use of tocilizumab to quell life-threatening immune system reactions. They discussed adding it to the COVID treatment guidelines.

Team member Christina Price, MD, associate professor of medicine (allergy & immunology) and an expert in clinical immunology, and colleagues designed a protocol to administer tocilizumab to very ill COVID-19 patients at YNHHS. After seeing an improvement in these patients, they offered the drug to less severely ill COVID patients, with similar outcomes. The results of this study were published in the journal Chest (October 2020), with Price as lead author.

Serving as a bridge between the ad hoc committee and the hospital, Topal shared the treatment algorithm with YNHHS care providers. “We used the System Incident Management System (SIMS) communication model to disseminate the information to medical staff,” he explains. “We also provided in-services to staff, as well as expanded ID oversight, by repurposing our Antibiotic Stewardship Module in Epic to allow a team of providers to review patients quickly and thoroughly, providing patient-specific treatment recommendations.”

Topal created a COVID-19 admission order set to streamline laboratory testing and the administration of COVID therapeutics. The treatment algorithm was also translated into the first inpatient Care Signature Pathway to guide health care workers through clinical and therapeutic recommendations for COVID-19 care. Additionally, the YSM communications team posted the algorithm on the school’s website and on Twitter, along with timely updates.

Taking the guesswork out of treatment, the algorithm was well received by clinical staff, says Malinis. “Our hospitalists and other colleagues told us that the guidelines alleviated some of the anxiety about treating COVID.”

At a media briefing in held in March 2022, YNHH chief medical officer Thomas Balcezak, MD, MPH, noted that the YNHH COVID-19 mortality rate — at 8.2 percent — was not only significantly less than the national average of 24.6 percent, but also remained constant across different ethnicities and races.

“The success of this effort is attributable to every worker in our health system,” says Malinis. “They put their lives at risk, not knowing what they were dealing with. They truly are health care heroes.

“We are fortunate to be in a community who works and supports each other,” she adds. “I’m proud of the way we were able to support our front-line providers by providing a standard care approach to COVID-19. This allowed them to focus on bedside patient care rather than navigating through this alone during a period of limited data.”

Submitted by Julie Parry on September 20, 2022