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OpenTrials
Completed

NCT Number: NCT04371315

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

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

Completed

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Key information

Conditions

Corona Virus Infection Adult Children Cancer Coronaviridae Infections Coronavirus Infections Infections Neoplasms Nidovirales Infections Pediatric Cancer RNA Virus Infections Virus Diseases

Age range

Up to 24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Immunologic response to acute respiratory infection due to COVID-19 in children.

    Time frame: Baseline-day 60

    Immunological (Absolute lymphocyte/monocyte counts (mm3) response measures, will be summarized with mean, standard deviation, median and range.

  2. Immunologic response to acute respiratory infection due to COVID-19 in children.

    Time frame: Baseline-Day 60

    Immunological (Immunoglobulin level (mg/dL)) response measures, will be summarized with mean, standard deviation, median and range

  3. 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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 1, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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