Clinical trial NCT04371315: Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
Official title: Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corona Virus Infection
Pediatric Cancer
Adult Children
Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 400
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

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

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.

Eligibility 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

Primary outcomes:
measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.
timeFrame: Baseline-Day 60
measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children.
timeFrame: Baseline-day 60
Secondary outcomes:
measure: Immunologic response to acute respiratory infection due to COVID-19 in children.
timeFrame: Baseline-day 60
measure: Immunologic response to acute respiratory infection due to COVID-19 in children.
timeFrame: Baseline-Day 60
measure: Duration of viral shedding and evolution in children longitudinally.
timeFrame: Baseline-Day 60
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Diego Hijano, MD
role: PRINCIPAL_INVESTIGATOR
References: