Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Overview

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19.

Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future.

Primary Objective

- To determine the clinical characteristics and outcomes of Covid-19 in children.

- To characterize the clinical risk factors of Covid-19 in children..

Secondary Objectives

- To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children.

- To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2021

Detailed Description

Nasal swabs will be collected from positive patient participants on Day 0. Timing of follow-up swabs will be guided by standard of care procedures.

Whole blood will be collected at Days 0. Follow-up blood sampling will be guided by standard of care procedures. Samples will be stored at -80oC.

Nasal swabs and whole blood will only be obtained at the same time standard of care procedures are performed. If a patient is not getting a blood draw, no sample will be collected.

Arms, Groups and Cohorts

  • Positive COVID-19
    • Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected Monthly follow-up until Covid-19 is negative: Respiratory and Whole Blood Samples Collected
  • Negative COVID-19
    • Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected

Clinical Trial Outcome Measures

Primary Measures

  • Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.
    • Time Frame: Baseline-Day 60
    • Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.
  • Clinical risk factors of acute respiratory infection due to COVID-19 in children.
    • Time Frame: Baseline-day 60
    • Pearson or Spearman’s correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.

Secondary Measures

  • Immunologic response to acute respiratory infection due to COVID-19 in children.
    • Time Frame: Baseline-day 60
    • Immunological (Absolute lymphocyte/monocyte counts (mm3) and Immunoglobin level (mg/dL) response measures, will be summarized with mean, standard deviation, median and range.
  • Duration of viral shedding and evolution in children longitudinally.
    • Time Frame: Baseline-Day 60
    • The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.

Participating in This Clinical Trial

Patient Participant Inclusion Criteria:

  • Less than 24 years old at the time of enrollment on study.
  • St. Jude patients with laboratory confirmed Covid-19.

Exclusion Criteria

  • NA

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Jude Children’s Research Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Diego Hijano, MD, Principal Investigator, St. Jude Children’s Research Hospital
  • Overall Contact(s)
    • Diego Hijano, MD, 866-278-5833, referrainfo@stjude.org

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