Rho, a full-service contract research organization (CRO), has announced it is coordinating a new study, called Human Epidemiology and Response to SARS-CoV-2 (HEROS), to help determine the rate of the new coronavirus infection in children and their family members in the U.S. The study also aims to determine what percentage of children infected with SARS-CoV-2, the virus that causes COVID-19, develop symptoms of the disease, as well as whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not. HEROS is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“As the clinical research industry together strives to develop effective treatments to combat COVID-19, Rho is grateful to do its part in helping understand the effect the new virus has on children, especially those with asthma and allergies,” said Laura Helms Reece, CEO, Rho. “Our team brings vast experience with a broad range of respiratory indications-including asthma, allergies, and respiratory infections-to the HEROS study.”
The HEROS study team is rapidly enrolling 6,000 people from 2,000 U.S. families currently participating in NIH-funded pediatric research studies in 11 cities. Study participants will include both children identified as being in good health and children with asthma or other allergic conditions. The study team will prospectively observe these children and their families for six months to determine who gets infected with SARS-CoV-2, whether the virus is transmitted to other family members and which family members with the virus develop COVID-19 as a result. The HEROS study will be conducted as a virtual trial, allowing subjects to complete the study almost entirely from home, including the self-collection of nasal swabs, blood and stool samples.
Rho is participating under an administrative supplement to its Division of Allergy, Immunology, and Transplantation Statistical and Clinical Coordinating Center (DAIT SACCC) award (3UM2AI117870-06S1). The study is led by Tina V. Hartert, MD, MPH at the Vanderbilt University School of Medicine in Nashville. Samuel J. Arbes, Jr., DDS, MPH, Ph.D., who serves as the Asthma and Allergic Diseases Group Lead within the DAIT SACCC, will lead the research support at Rho.
As the DAIT SACCC, Rho is working closely with DAIT, Vanderbilt and other investigators to plan and execute the study design. Additionally, the CRO is providing operational management and oversight for all aspects of the study, including logistical support for biospecimen collection; collaboration with Vanderbilt to plan, implement, and monitor study data collection; timely reporting of safety events; and study data analysis and reporting.