NEW YORK — The US National Institutes of Health said on Monday that it has launched a clinical study aimed at understanding the effects of SARS-CoV-2 in children.
According to the NIH, the study — called Human Epidemiology and Response to SARS-CoV-2, or HEROS — is focused on determining what percentage of children infected with the virus develop symptoms of COVID-19. It will also examine whether rates of SARS-CoV-2 infection differ between healthy children and ones with asthma or other allergic conditions.
The NIH noted that preliminary data suggest that having an allergic condition may reduce susceptibility to SARS-CoV-2 infection and severe COVID-19. Meanwhile, a recent National Institutes of Allergy and Infectious Diseases-funded study found that respiratory allergy, asthma and controlled allergen exposure were associated with significantly reduced expression of ACE2, a gene that encodes a receptor used by SARS-CoV-2 to infect cells, in airway cells.
As such, HEROS will also help further clarify whether reduced ACE2 gene expression in airway cells of children with allergic diseases correlates with a lower rate of SARS-CoV-2 infection and COVID-19, the NIH said.
HEROS will enroll up to 6,000 people from 2,000 US families that are already participating in NIH-funded pediatric research, including both healthy children and those with asthma or other allergic conditions. Participants will be prospectively followed for six months to determine who gets infected with SARS-CoV-2, whether the virus is transmitted to other family members, and which infected individuals develop COVID-19 symptoms.
In the study, caregivers will collect nasal swabs and blood samples from study participants, as well as stool samples from those with suspected COVID-19. The blood samples will be analyzed for antibodies against SARS-CoV-2, while the swabs will undergo PCR- and next-generation sequencing-based testing.
The caregivers will also fill out online questionnaires regarding participants' current symptoms, social distancing practices, recent activities outside the home, and recent exposure to people who are sick.
"So far, data on the extent of SARS-CoV-2 infection in the US population have been limited to people who physically interact with the healthcare system: those who are tested, especially those who test positive, and those with severe disease," Vanderbilt University's Tina Hartert, who is leading the study, said in a statement. "These data provide real-time guidance in a setting of limited test availability, but they don't enable us to understand the full extent of SARS-CoV-2 infection in the entire population. The HEROS study will help fill this knowledge gap and inform public health interventions."
The new initiative follows a study announced by the NIH last month to determine how many adults may be infected with the coronavirus.