National Children’s Hospital and NIAID launch large study



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Washington DC, July 20, 2021 (GLOBE NEWSWIRE) – Up to 2,000 children and young adults will be enrolled in a study at Children’s National Hospital in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID) that will examine the long- effects term of COVID-19 and pediatric multisystem inflammatory syndrome (MIS-C) after these patients have recovered from COVID-19 infection.

This multi-year, $ 40 million study will provide important information on quality of life and social impact, in addition to a better understanding of the long-term physical impact of the virus, including effects on the heart and patients. lungs. Researchers hope to detail the role of genetics and immune response to COVID19, known as “long COVID” and MIS-C, including the duration of immune responses from SARS-CoV-2, the virus that causes COVID-19 . It is fully funded through a subcontract with the Frederick National Laboratory for Cancer Research, funded by NIH and operated by Leidos Biomedical Research, Inc.

“We don’t know the unique long-term impact of COVID-19 or MIS-C on children, so this study will provide us with a critical missing piece of the puzzle,” says Roberta DeBiasi, MD, MS, head of the pediatric infectious disease division at Children’s National and principal investigator for this study. “I hope the lessons from this huge effort will help us improve the treatment of both COVID-19 and MIS-C in the pediatric population both nationally and globally. “

In the past year, more than 3.6 million children have tested positive for SARS-CoV-2 and more than 2,800 cases of MIS-C have been reported in the United States. or no symptoms, some develop serious illness and may require hospitalization, including life-sustaining measures. In rare cases, some children who have previously been infected or exposed to someone with SARS-CoV-2 have developed MIS-C, a serious illness that can be associated with the virus. Symptoms of MIS-C may include fever, abdominal pain, bloodshot eyes, difficulty breathing, rash, vomiting, diarrhea, and neck pain, and may progress to shock with severe pain. low blood pressure and poor heart function. The long COVID is a wide range of symptoms that can last or appear weeks or even months after becoming infected with the virus that causes COVID-19.

The study is designed to recruit at least 1,000 children and young adults under the age of 21 who have a confirmed history of symptomatic or asymptomatic infection with SARS-CoV-2 or MIS-C. Participants who enroll within 12 weeks of an acute infection will attend study visits every three months for the first six months, and then every six months for three years. Participants who enroll more than 12 weeks after acute infection will participate in study visits every six months for three years. The study will also recruit up to 1,000 family contacts to serve as a control group, and up to 2,000 parents or guardians (one parent per participant) will complete targeted questionnaires.

“The large number of patients who will be enrolled in this study should provide us with a truly comprehensive understanding of how the virus may continue to affect some patients long after the infection is gone,” said Dr DeBiasi.

The main objective of the study is to determine the incidence, prevalence and risk factors of certain long-term medical conditions in children with MIS-C or a previous infection with SARS-CoV-2. The study will also assess the health-related quality of life and social impacts for participants and establish a bioreference that can be used to study the roles of host genetics, immune response, and other possible influencing factors. long-term results.

Children’s National was one of the first US institutions to report that children can get very sick from SARS-CoV-2 infection, despite early reports that children have not been seriously affected. In studies published in the Pediatric Journal in May from 2020 and June from 2021, Children’s National researchers found that approximately 25% of symptomatic COVID patients who sought care at our facility required hospitalization. Of those hospitalized, about 25% required resuscitation measures and the remaining 75% required standard hospitalization. Of the patients with MIS-C, 52% were critically ill.

Study sites include the inpatient and outpatient clinics at Children’s National Hospital in the Washington, DC area, and the NIH Clinical Center in Bethesda, Maryland.

Those interested in participating should submit this form. You will then be contacted by a member of the study team to review the details of the study and determine if you are eligible to participate.

You can find more information about the study.

Media contact: Beth Riggs | [email protected] | 202-476-4500


        
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