The Duke Clinical Research Institute (DCRI) has been named the Clinical Trials Data Coordinating Center for large-scale national research studies aimed at understanding and improving the treatment of long COVID.
As the data coordinating center, DCRI will partner with RTI International, the study’s Administrative Coordinating Center, to accelerate the clinical trial process, oversee the study’s program-wide infrastructure, establish a patient registry, and launch simultaneous prevention and therapeutic multi-intervention studies among adults and children.
The data coordinating center is part of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) initiative. In December 2020, Congress provided $1.15 billion in funding over four years for NIH to support research into the prolonged health consequences of SARS-CoV-2 infection.
RECOVER brings together patients, caregivers, clinicians, community leaders, and scientists from across the nation to understand, prevent, and treat long COVID. The initiative comprises multiple sub-awards to researchers at institutions across the country.
PASC (post-acute sequelae of SARS-CoV-2), or long COVID, refers to a wide range of physical and mental health symptoms that persist, recur or appear four or more weeks after the initial SARS-CoV-2 infection. Common symptoms include pain, headaches, fatigue, “brain fog,” shortness of breath, anxiety, depression, fever, chronic cough, and sleep problems, which can last months or longer.
The CDC indicates that 2.5% of people with COVID report lingering symptoms for three months or longer, but additional research is critical to better understand this relatively new illness.
The data coordinating center will align efforts across other existing COVID research projects such as the NIH-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) studies and the RECOVER Consortium. This will give people and research teams the opportunity to take part in long COVID studies and help advance science on the health effects of the disease.
“There is a lot we don’t know about long COVID, including how to precisely define it and why some people experience prolonged symptoms while others don’t,” said Kanecia Zimmerman, MD, principal investigator of the data coordinating center. “The RECOVER Initiative supports better understanding of the disease characteristics, prevention, and treatment.”
The DCRI has led or participated in more than 13 COVID-19-related awards since the onset of the pandemic in 2020. It has spearheaded projects that aim to reduce virus transmission in schools, maximize vaccine safety, expand testing access in underserved communities, and understand the impact of the pandemic on health care workers. The DCRI is also partnering with the NIH to lead trials testing repurposed medications for treating patients with mild or moderate COVID-19, and examining whether immune modulators can prevent overactive immune response in moderate and severe cases.
“From the onset of the pandemic, the DCRI has been at the forefront of COVID-19 research,” said Adrian Hernandez, MD, executive director of the DCRI. “We are excited to apply our expertise in leading large-scale research programs to find much needed answers to predict, prevent, and treat long COVID.”
In addition to Zimmerman, the data coordinating center will be led by DCRI faculty members Christina Barkauskas, MD, and Sean O’Brien, PhD.