The study, which will take place at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, is expected to provide significant insight into the effects of COVID-19 on children’s overall health, development and immune responses to infection, and overall quality of life in the three years following infection.
This research is part of the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative, which aims to better understand the long-term consequences of SARS-CoV-2 infection.
The study, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), will follow up to 1,000 children and young adults who have previously tested positive for COVID-19 for three years to assess the impact of COVID-19 on their physical and mental health.
The National Institutes of Health will follow up to 1,000 children and young adults who previously tested positive for COVID-19 for three years to assess the impact of COVID-19 on their physical and mental health.
Despite the fact that an increasing number of children are becoming eligible for a COVID-19 vaccine, the lack of vaccine-derived protection for the majority of children has made this age group particularly vulnerable to infection.
Furthermore, children can develop a slew of inflammatory symptoms known as Multisystem Inflammatory Syndrome in Children (MIS-C), which can affect multiple organs and lead to severe illness. Even if the child initially appeared to be asymptomatic for COVID, MIS-C can develop.
Participants will be subjected to a thorough physical examination as well as a thorough medical history. Baseline samples will be collected by study physicians, including blood, nasal swabs, stool, and urine.
A genetic analysis, which is optional, may be performed to identify potential genetic risk factors for severe COVID-19 outcomes. Participants will also have their hearts and other organs scanned.
Members of their households who do not have a history of COVID infection will be asked to join a control cohort as well. In total, up to 2,000 people may be enrolled in the study, including participants who have tested positive for COVID-19 and their household contacts.
Participants in the study will be enrolled with the permission of their parents or guardians. The NIH Clinical Center will recruit children aged 3 to 21 years, while Children’s National Hospital in Washington, DC will recruit children aged from birth to 21 years.
Children and young adults who enroll within 12 weeks of a COVID-19 infection or a positive COVID-19 test will be seen in a clinic at three and six months, and then every six months for the next three years.
Those who enroll more than 12 weeks after a positive COVID-19 test will be scheduled for six-month clinic visits for three years.
Any re-infections or adverse events associated with a previous COVID-19 infection will be documented. The researchers estimate that the study will take six years to complete.