Post-COVID study to enroll more than 900 in Northeast Ohio

Case Western Reserve University (CWRU) and its hospital partners, University Hospitals, the MetroHealth System, and the Louis Stokes Cleveland VA Medical Center, have received federal funding for a study that seeks to understand why some people have prolonged symptoms (referred to as long COVID) or develop new or returning symptoms after the acute phase of SARS-CoV-2 infection. 

The Northeast Ohio study, called “NEO-CURE,” is part of the National Institutes of Health (NIH) “Researching COVID to Enhance Recovery” (RECOVER) Initiative.

Grace McComsey, MD

Case Western Reserve University is the only Ohio site in the RECOVER Initiative’s implementation phase. The university and its clinical partners are projected to receive $17 million from NIH during up to four years of patient follow-up. 

The most common lingering symptoms include pain, headaches, fatigue, “brain fog,” shortness of breath, anxiety, depression, fever, chronic cough and sleep problems.

“How frequent is it? How long does it last? What makes it better? This study will answer a myriad of questions about the post-acute sequalae of SARS-CoV-2 infection (called PASC),” said NEO-CURE Contact Principal Investigator Grace McComsey, MD, an infectious diseases specialist and professor of medicine and pediatrics at CWRU, and also the Vice President of Research at University Hospitals of Cleveland.  

“We will reach out to community partners, all over the region, urban and rural, to recruit survivors, especially in the Latinx and African American communities that have been so heavily and disproportionately impacted by COVID-19,” Dr. McComsey said. “Having the community involved is essential to support future development of new therapies that will be effective in the people and communities we serve here in Northeast Ohio; we need to have our local experience with COVID represented in this national study,” Dr. Nora G. Singer (Professor and co-director CWRU CoV2 research taskforce, Director Rheumatology, MetroHealth) said.  

What happens during the study?

The NEO-CURE team will administer questionnaires to participants on a quarterly basis to document how they are feeling. Participants will also be asked to volunteer to have blood draws and collection of other biologic fluids. These specimens will be important in determining what are the risk factors or predictors of “long hauler syndrome” or PASC. Additionally, we want to know the range of long-term consequences of COVID, even in individuals who have seemingly recovered from symptoms. 

“Deep phenotyping will be done on a subset of participants, those who experience persisted or new symptoms evolved after COVID infection” said Dr. McComsey. “These tests would allow us to characterize the extent of damage to any organ systems caused by the virus.” Some of the long hauler symptoms resemble those seen in patients with autoimmune disease.  As such, studying the effects of COVID in patients with immune suppression due to medications, autoimmune diseases, cancer, primary immunodeficiency, HIV, as well as those who are disabled prior to COVID, will be of great importance in understanding how the body fights acute SARS CoV-2 and the long-term effects of COVID. Other aspects of health will be measured such as social determinants of health, metabolic and endocrine function, and subtle cardiac injury that may only be evident by specialized imaging.

The NIH RECOVER Initiative cohort studies, funded by the NIH at nearly $470 million, are an important step in addressing a long-term public health problem. The U.S. Centers for Disease Control and Prevention data tracker in September reported that the nation had reached 40 million cases of COVID-19 since the pandemic began. Millions of other cases undoubtedly have gone untested and unreported. “If there are 100 million people who have had COVID-19 nationwide, even if 5% get these complications, that’s a huge health care crisis,” Dr. McComsey said. “These people had very active lives before COVID and some of them are now disabled, living with many symptoms and a fear of getting worse. We are excited to be part of this NIH initiative and help understand and treat this major healthcare issue.”