A Study to Expand Understanding of Coronavirus in U.S. Children (Enrolling by Invitation Only)

Overview

About this study

The purpose of this study is to evaluate the influenza vaccine effectiveness for preventing severe and life-threatening influenza-associated illness in children 6 months to 17 years of age.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Admission to the hospital at any point during illness.
  • ≤ 25 years of age (as of October 15, 2020 only patients < 21 years of age are eligible).
  • Hospitalization is associated with SARS-CoV-2 with either:
    • SARS-CoV-2 positive test (PCR or antibody) prior to, on admission or during hospitalization; OR
    • Strong clinical suspicion (with confirmed exposure) that complications are due to COVID-19 despite negative SARS-CoV-2 test.
  • (as of October 15, 2020) Symptoms or signs of disease thought to be due to COVID-19 or MIS-C OR an asymptomatic patient with BCH coordinating site approval.

Exclusion Criteria:

  • Never tested for SARS-CoV-2.
  • Hospitalization is associated with a non-COVID-related acute disorder that may result in significant changes in their immune response (e.g., burns, crush injury, major trauma) (exclusion criteria 3-6 added for patients enrolled October 15th, 2020 onwards).
  • Nosocomial SARS-CoV-2 infection.
  • Acquired immune compromise at baseline (HIV; on active chemotherapy; active cancer; on immune modulating therapy for rheumatologic, immune, or oncologic disorders or after transplantation to prevent rejection).
  • Limitations on life support due to poor prognosis.
  • End stage lung disease awaiting transplant or needing chronic mechanical ventilator support.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Emily Levy, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Emily Levy M.D.

(507) 255-8464

Levy.Emily@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20502644

Mayo Clinic Footer