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

St. Jude Children's Research Hospital

Status: Enrolling

Conditions: Corona Virus Infection; Cancer; Pediatric Cancer; Adult Children

Study type: Observational

Funder types: Other

Identifiers

NCT04371315

COVID-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 2 patient groups

Positive COVID-19

Description:

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

Description:

Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected