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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371315
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

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

Condition or disease
Corona Virus Infection Pediatric Cancer Adult Children Cancer

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants who meet eligibility criteria and consent to enrollment on the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371315


Contacts
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Contact: Diego Hijano, MD 866-278-5833 referrainfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Diego Hijano, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Diego Hijano, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Diego Hijano, MD St. Jude Children's Research Hospital
Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT04371315    
Other Study ID Numbers: COVID-19
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases