Up to 2,000 children and young adults will be enrolled in a study by the Children’s National Hospital in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to investigate the long-term effects of COVID-19 and multisystem inflammatory syndrome in children (MIS- C) after these patients recover from COVID-19 infection.
This $ 40 million multi-year study will provide vital information about quality of life and social impact, in addition to a better understanding of the virus’ long-term physical effects, including heart and lung effects. Researchers hope to detail the role of genetics and the immune response to COVID19, called “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 by a subcontract with the NIH-funded Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, Inc.
“We are not aware of the unique long-term effects of COVID-19 or MIS-C on children, so this study will provide us with a critical missing piece of the puzzle,” said Roberta DeBiasi, MD, MS, director of Pediatric Infectious Diseases at Children’s National lead researcher for this study. “I hope that the lessons learned from these tremendous efforts will help us improve the treatment of COVID-19 and MIS-C in children and adolescents nationally and globally.”
Last year, more than 3.6 million children tested positive for SARS-CoV-2, and in the US, over 2,800 cases of MIS-C have been reported or have no symptoms, some develop serious illness and may require hospitalization, including life support . In rare cases, some children who have previously been infected or exposed to someone with SARS-CoV-2 have developed MIS-C, a serious condition that may be linked to the virus. MIS-C symptoms can include fever, abdominal pain, bloodshot eyes, difficulty breathing, rash, vomiting, diarrhea, and neck pain, and can result in shock with low blood pressure and inadequate heart function. Long-term COVID is a wide range of symptoms that can persist or occur weeks or even months after becoming infected with the virus that causes COVID-19.
The study will enroll at least 1,000 children and young adults under the age of 21 who have a confirmed history of symptomatic or asymptomatic SARS-CoV-2 or MIS-C infection. 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 an acute infection will attend study visits every six months for three years. The study will also include up to 1,000 household contacts 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 enrolled in this study should give us a really full understanding of how the virus can affect some patients long after the infection has cleared,” says Dr. DeBiasi.
The primary aim of the study is to determine the incidence and prevalence as well as risk factors for certain long-term illnesses in children with MIS-C or a previous SARS-CoV-2 infection. The study will also assess health-related quality of life and social impact for participants, and establish a bio-repository that can be used to examine the role of host genetics, immune response, and other possible factors that affect long-term outcomes.
Children’s National was one of the first US institutions to report that children can become seriously ill with SARS-CoV-2 infection, although it was previously reported that children were not seriously affected. In studies published in the Journal of Pediatrics in May 2020 and June 2021, researchers from Children’s National found that approximately 25% of symptomatic COVID patients treated at our facility required hospitalization. Of those admitted to the hospital, about 25% required life support and the remaining 75% required normal hospitalization. Of the patients with MIS-C, 52% were critically ill.
Study centers include inpatient and outpatient clinics at Children’s National Hospital in the Washington, DC area and the NIH Clinical Center in Bethesda, Maryland.
Anyone interested in participating should submit this form. You will then be contacted by a study team member to review the study details and determine if you are eligible to participate.
Up to 2,000 children and young adults will be enrolled in a study by the Children’s National Hospital in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to investigate the long-term effects of COVID-19 and multisystem inflammatory syndrome in children (MIS- C) after these patients recover from COVID-19 infection.
This $ 40 million multi-year study will provide vital information about quality of life and social impact, in addition to a better understanding of the virus’ long-term physical effects, including heart and lung effects. Researchers hope to detail the role of genetics and the immune response to COVID19, called “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 by a subcontract with the NIH-funded Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, Inc.
“We are not aware of the unique long-term effects of COVID-19 or MIS-C on children, so this study will provide us with a critical missing piece of the puzzle,” said Roberta DeBiasi, MD, MS, director of Pediatric Infectious Diseases at Children’s National lead researcher for this study. “I hope that the lessons learned from these tremendous efforts will help us improve the treatment of COVID-19 and MIS-C in children and adolescents nationally and globally.”
Last year, more than 3.6 million children tested positive for SARS-CoV-2, and in the US, over 2,800 cases of MIS-C have been reported or have no symptoms, some develop serious illness and may require hospitalization, including life support . In rare cases, some children who have previously been infected or exposed to someone with SARS-CoV-2 have developed MIS-C, a serious condition that may be linked to the virus. MIS-C symptoms can include fever, abdominal pain, bloodshot eyes, difficulty breathing, rash, vomiting, diarrhea, and neck pain, and can result in shock with low blood pressure and inadequate heart function. Long-term COVID is a wide range of symptoms that can persist or occur weeks or even months after becoming infected with the virus that causes COVID-19.
The study will enroll at least 1,000 children and young adults under the age of 21 who have a confirmed history of symptomatic or asymptomatic SARS-CoV-2 or MIS-C infection. 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 an acute infection will attend study visits every six months for three years. The study will also include up to 1,000 household contacts 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 enrolled in this study should give us a really full understanding of how the virus can affect some patients long after the infection has cleared,” says Dr. DeBiasi.
The primary aim of the study is to determine the incidence and prevalence as well as risk factors for certain long-term illnesses in children with MIS-C or a previous SARS-CoV-2 infection. The study will also assess health-related quality of life and social impact for participants, and establish a bio-repository that can be used to examine the role of host genetics, immune response, and other possible factors that affect long-term outcomes.
Children’s National was one of the first US institutions to report that children can become seriously ill with SARS-CoV-2 infection, although it was previously reported that children were not seriously affected. In studies published in the Journal of Pediatrics in May 2020 and June 2021, researchers from Children’s National found that approximately 25% of symptomatic COVID patients treated at our facility required hospitalization. Of the hospitalized patients, approximately 25% required life support and the remaining 75% required standard hospitalization. Of the patients with MIS-C, 52% were critically ill.
Study centers include inpatient and outpatient clinics at Children’s National Hospital in the Washington, DC area and the NIH Clinical Center in Bethesda, Maryland.
Anyone interested in participating should submit this form. You will then be contacted by a study team member to review the study details and determine if you are eligible to participate.
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You can find more information about the course.
Media contact: Beth Riggs | [email protected] | 202-476-4500
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