Adult Children, Cancer, Corona Virus Infection, Pediatric Cancer
Conditions
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.
Interventions
None listed
Sponsors
St. Jude Children's Research Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics and outcomes of acute respiratory infections due to COVID-19 in children. | Baseline-Day 60 | 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. |
| Clinical risk factors of acute respiratory infection due to COVID-19 in children. | Baseline-day 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunologic response to acute respiratory infection due to COVID-19 in children. | Baseline-day 60 | Immunological (Absolute lymphocyte/monocyte counts (mm3) response measures, will be summarized with mean, standard deviation, median and range. |
| Duration of viral shedding and evolution in children longitudinally. | Baseline-Day 60 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDiego Hijano, MD
St. Jude Children's Research Hospital
Outcome results
None listed