Purpose

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

Eligibility

Eligible Ages
Under 24 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

St. Jude Children's Research Hospital
Memphis, Tennessee 38105
Contact:
Diego Hijano, MD
866-278-5833
referralinfo@stjude.org

More Details

NCT ID
NCT04371315
Status
Recruiting
Sponsor
St. Jude Children's Research Hospital

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.