More than 20 trials targeting the diagnosis, treatment and long-term health of patients with COVID-19 have been launched by the Division of Pulmonology, Allergy and Critical Care Medicine since the coronavirus first presented at Duke Health early in 2020.

Ranging from clinical analyses of treatment techniques and long-term effects of the virus to retrospective assessments of the use of bronchoscopy and tracheostomy to test for infection, the trials also include investigations of provider burnout and reviews of crisis management coaching for faculty and trainee wellness.

“Our clinical trials have been designed with broad goals to cover a wide spectrum of clinical and biological objectives, including several that focus on the health of our providers,” says Patty J. Lee, MD, pulmonology division chief. “Because our division has a front-line role in treating the respiratory effects of the pandemic with a history of top-notch programs, we are well positioned for these studies.”

Lee helped secure U.S. Department of Defense and philanthropic funding from The Marcus Foundation for two studies that focus on building resiliency while decreasing burnout among providers, as well as stress-related immune effects of the pandemic on providers. Nearly 400 physicians, nurses, house staff and trainees will participate in the trials. Medical research is a major focus of The Marcus Foundation. Founded in 1998, the organization fulfills the vision of Bernie Marcus, co-founder of The Home Depot.

Pulmonology division providers are leading trials to treat COVID-19 patients admitted to Duke Health hospital inpatient wards and ICUs. The trials also include patients referred to the outpatient pulmonary clinics with persistent respiratory symptoms post-COVID.

The new pulmonology trials offer clinicians novel cutting edge therapies to help patients, Que says. “From the perspective of the patient, the possibility of sharing their data and/or clinical samples allows them to help others who have become infected with COVID,” says Loretta G. Que, MD, director of the Duke Pulmonary Clinical Research Unit. Dr. Que coordinates the division’s participation in clinical trials sponsored by industry as well as the National Institutes of Health.

Coral Giovacchini, MD, a critical care specialist and interventional pulmonologist, leads an analysis of asthma and shortness-of-breath symptoms among patients who have had the coronavirus.

“We are seeing a lot of lingering shortness of breath, cough and post-viral reactive airway disease which can present similar to asthma,” Giovacchini says. “We have previously seen these symptoms among patients recovering from other more typical viral illnesses such as severe influenza, but the COVID-related effects tend to last longer for some patients.” As is standard for many post-coronavirus studies, initial follow-ups will be scheduled 6 to 8 weeks after discharge followed by quarterly office visits during the next year.

Because of the spike in COVID-19 cases late in 2020 and early 2021, the disease burden has become a significant factor, Giovacchini says. “Both acute infections and the aftermath of the infections are having a significant impact on both patient lives and the health system,” she says.

“To make sure we are returning people to health and helping them to better navigate the healthcare system as impacted by this virus, we need to learn as much as we can about the disease process and the most effective treatments for patients and their families.”

The trials also include collaborative approaches between pulmonology and cardiology with the same goal of assessing long-term effects on the heart and cardiovascular system. Here is a partial list of the trials:

• Biomarkers of lung injury in COVID-19-associated Acute Respiratory Distress Syndrome (ARDS)  

• Bronchoalveolar lavage in COVID-19 patients with respiratory failure

• Addressing psychological distress symptoms among serious illness survivors of a viral pandemic with a completely self-directed, symptom-responsive mobile mindfulness intervention.

• Prone position and respiratory outcomes in non-intubated COVID-19 patients

• Quantitative viral loads in COVID-19 infection

• Whole exome sequencing in COVID-19

• T-cell telomeres and COVID-19 severity

• Resilience in the time of COVID-19--an ethnographic study of ICU workers

• Biomarkers of lung injury and recovery in ICU patients with COVID-19

• Targeting the health care provider in burnout crisis during the COVID-19 pandemic

• Data-driven approaches to provider resilience and burnout

• Biomarkers of lung and vascular injury in COVID-19 autopsies

• Effectiveness of crisis management coaching on faculty and trainee wellness during COVID-19

• Biomarkers of lung and vascular injury in COVID-19 autopsies

• Retrospective: Bronchoscopy to assess for COVID-19 respiratory infection

• Retrospective: Tracheostomy in COVID-19 patients with respiratory failure

• Functional and genetic characterization of red blood cells in critically ill patients with COVID-19

• Duke pulmonary clinical biorepository: Post COVID-19

• COVID-19: Community and stakeholder perspectives on race disparities

• Effect of COVID-19-driven clinical care changes in lung transplant recipients

• Characterizing the long-term cardiopulmonary effects of COVID-19 with hyperpolarized xenon and cardiac MRI