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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04371315
• Other study ID #: COVID-19
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: St. Jude Children's Research Hospital
• Contact: Diego Hijano, MD
• Phone: 866-278-5833
• Email: referrainfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Children
• Cancer
• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infections
• Pediatric Cancer

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.	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.	Baseline-Day 60
Primary	Clinical risk factors of acute respiratory infection due to COVID-19 in children.	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.	Baseline-day 60
Secondary	Immunologic response to acute respiratory infection due to COVID-19 in children.	Immunological (Absolute lymphocyte/monocyte counts (mm3) response measures, will be summarized with mean, standard deviation, median and range.	Baseline-day 60
Secondary	Immunologic response to acute respiratory infection due to COVID-19 in children.	Immunological (Immunoglobulin level (mg/dL)) response measures, will be summarized with mean, standard deviation, median and range	Baseline-Day 60
Secondary	Duration of viral shedding and evolution in children longitudinally.	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.	Baseline-Day 60

External Links

•   Clinical Trials Open at St.Jude
•   St. Jude Children's Research Hospital