Corona Virus InfectionNCT04371315
Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
An observational study of Corona Virus Infection and Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Corona Virus Infection, Pediatric Cancer, Adult Children
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2020to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
None listed.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read more
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
Read the 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.
- Conditions
- Corona Virus Infection, Pediatric Cancer, Adult Children, Cancer
- Medical subject headings
- Coronavirus Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline-day 60
Secondary outcomes (3)
Immunologic response to acute respiratory infection due to COVID-19 in children.
Immunological (Absolute lymphocyte/monocyte counts (mm3) response measures, will be summarized with mean, standard deviation, median and range.
Measured: Baseline-day 60
Immunologic response to acute respiratory infection due to COVID-19 in children.
Immunological (Immunoglobulin level (mg/dL)) response measures, will be summarized with mean, standard deviation, median and range
Measured: Baseline-Day 60
Duration of viral shedding and evolution in children longitudinally.
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.
Measured: Baseline-Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start27 Apr 2020
- Primary completion2 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Hijano, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371315
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2020
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
- ClinicalTrials.gov ID
- NCT04371315
- Acronym / sponsor ID
- COVID-19
- Conditions
- Corona Virus Infection, Pediatric Cancer, Adult Children, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.
Time frame: 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.
Time frame: 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.
3 secondary outcomes
Immunologic response to acute respiratory infection due to COVID-19 in children.
Time frame: Baseline-day 60
Immunologic response to acute respiratory infection due to COVID-19 in children.
Time frame: Baseline-Day 60
Duration of viral shedding and evolution in children longitudinally.
Time frame: Baseline-Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St.JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Hijano, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics and outcomes of acute respiratory infections due to COVID-19 in children. (time frame: Baseline-Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.