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

NCT04371315 | Completed

• 1 other identifier: COVID-19
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Cancer; Adult Children; Corona Virus Infection; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

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

  Baseline-day 60

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

  Baseline-Day 60

• Duration of viral shedding and evolution in children longitudinally.

  Baseline-Day 60

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Coronavirus Infections; Neoplasms

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Diego Hijano, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 1, 2020
• Study Start: April 27, 2020
• Primary Completion: February 2, 2026
• Study Completion: March 3, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)