This study led by the UNC Institute for Global Health & Infectious Diseases, will enroll 7,500 COVID-positive individuals to answer some of the biggest questions about COVID-19. Investigators explain the study in this video.
Over two years into the COVID-19 pandemic and researchers still are looking to answer some of most COVID-19 burning questions such as how common is long COVID, how well previous infection and vaccinations protect against re-infection with new variants of the virus, and what factors are associated with COVID rebound. A new North Carolina study called VISION, funded by the N.C. Collaboratory, will enroll 7,500 adults recently diagnosed with COVID-19 to understand the different factors that impact individual risk for key clinical outcomes including recovery from acute illness, symptom rebound, re-infection, and long COVID.
“There’s still a lot we don’t know about COVID-19,” said David Wohl, MD, UNC Professor of Infectious Diseases and co-lead of the study. “If the past is any indication of the future, we are going to be dealing with COVID-19 for a long time and that means people will continue to get infected and then re-infected. The more that we learn now, the better prepared we will be in the future.”
As the largest observational study of its kind in North Carolina, VISION will answer critical questions by following people over time. All of the 7,500 people who join the study will regularly complete online surveys about their health and 750 of them will also be seen in person for blood and nasal swab tests.
For the people, by the people
Funded by the state legislature for the people of North Carolina, VISION participants will complete the online surveys for up to 72 weeks.
Participants must be 18 years and older who live in North Carolina, who have tested positive for COVID-19 within the past seven days or have a rebound in COVID-19 symptoms within seven days of completing a COVID-19 treatment. They also must be outpatients and able to answer surveys online in English or Spanish.
A subset of these participants can volunteer to provide respiratory samples, as well as blood samples, so that researchers can assess changes in the level of SARS-CoV-2 and in immune system responses over time. Another subset of individuals who received treatment with oral COVID-19 medications will be asked to provide nose swabs and blood and urine samples, as researchers look for host genetic changes over time.
Leading in COVID research throughout the pandemic
VISION is the newest COVID study utilizing the centralized infrastructure of the UNC Institute for Global Health & Infectious Diseases to produce high quality research. This infrastructure has already allowed UNC to be a site for important clinical research, including the Moderna and Novavax vaccine trials and COVID therapeutic trials.
Wohl, Billy Fischer, MD, Myron Cohen, MD, and Joseph Eron, MD, led early studies on monoclonal antibodies sponsored by the NIH. Over 20,000 people have received a monoclonal antibody infusion to treat COVID-19 at UNC Health.
For researchers, most concerning is that they have had to evaluate vaccines and therapeutics, capturing safety and efficacy against specific variants, in moments of time, because new variants have appeared. VISION will address the growing need to understand the impact of prior infection and vaccination on the protection of individuals against COVID.
“There has been a pivot from focusing on care for hospitalized patients to what we can do for people who are outpatients to prevent their progression to severe disease. And what has quickly become clear is that access to therapeutics, just like access to vaccinations, is a major weapon in the fight against this virus. As the virus has continued to shift and change, we need to understand how well our vaccines and treatments keep up,” said Fischer, the Director of Emerging Pathogens at the UNC Institute of Global Health & Infectious Diseases, principal investigator of VISION, and Associate Professor of Pulmonary Diseases and Critical Care Medicine.
Both Fischer and Wohl point out how little is also known about long COVID, although by some estimates 1 in 5 persons with symptomatic COVID-19 may experience lingering effects of the infection.
“The VISION study will be important in understanding how the virus behaves differently in different patient populations,” Fischer said. “It will also allow us to understand the immune response to the virus, especially as new variants emerge, and the influence of prior vaccination, prior infection and therapeutics on the things that matter most – how people feel.”