Title: A multi-center study to describe the epidemiology, clinical presentation, and outcomes of pediatric patients with Covid-19 across the United States.
Coordinating Center Mnemonic/Study Number: PIDTRAN-6_COVID-19
Coordinating Center: St. Jude Children’s Research Hospital, Department of Infectious Diseases, Memphis, TN
Principal Investigator: Gabriela Maron, MD
Coordinating Center Team:
Hailey Skonhovd, MPH – Project Coordinator
Jose Ferrolino, MD MPH – Data Manager/Analyst
Ronald Dallas, PhD – Coordinating Center Manager
Study Summary: As the novel coronavirus (Covid-19) pandemic continues to spread, understanding the epidemiology of the new virus will be crucial for developing effective prevention and treatment strategies. The COVID-19 clinical presentation is poorly defined in pediatric populations, as most of the reported known cases are adults. We aim to describe the epidemiology, clinical presentation and management, as well as the outcomes associated with COVID-19 among pediatric patients across the United States of America. To address these aims, we will conduct a secondary data use study among pediatric centers coordinated by the Pediatric Infectious Diseases Transplant Network (PIDTRAN) coordinating center housed at St. Jude. Deidentified data relating to risk factors, treatment, and outcomes among Covid-19 pediatric cases will be entered by sites into a REDCap database housed at St. Jude. No PHI will be entered in database or shared with the coordinating center.
Study Design: Observational, surveillance study utilizing secondary data originally collected for standard of care
Primary Objective: To describe the epidemiology, clinical presentation, risk factors, treatment and outcomes of pediatric patients with COVID-19 across the United States of America.
Secondary Objectives: (1) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in HCT pediatric patients with COVID-19. (2) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in pediatric immunocompromised patients with COVID-19. (3) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in the general pediatric population with COVID-19.
Eligibility: Pediatric patients (< 21 years old at the time of Covid-19 diagnosis) in the United States who are Covid-19 positive.
Data Collection Methods:
Confidentiality:
Risk Benefit Analysis: This secondary data use study will not confer any additional risks to patients entered in the study survey. The only risk to patients is breach of confidentiality. Sites will access patient records containing PHI to enter information into the study survey. To minimize this risk as much as possible, no PHI will be entered in the study survey and sites will not share any PHI with other sites or the coordinating center. There is no benefit to patients entered in the study survey; however, future patients diagnosed with Covid-19 may benefit from the information learned from this study.
Consent Waiver: This study meets Category 4 - §46.104(d)(4), which is secondary research for which consent is not required.
Dissemination of Results:
Access to the data:
IRB Exemption Categories:
Category 4 - §46.104(d)(4) - Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
St. Jude Children’s Research Hospital IRB Approval Date: March 25, 2020
Per the IRB approval letter: We have determined that the other sites providing clinical (NON-HIPAA identifiable) data to this project are NOT engaged in human subjects activities based on OHRP's October 16, 2008 “Guidance on Engagement of Institutions in Human Subjects Research”. Therefore, their role in the project does NOT need local IRB approval at their sites unless local policy dictates otherwise.
For further information, please contact: [email protected].
Coordinating Center Mnemonic/Study Number: PIDTRAN-6_COVID-19
Coordinating Center: St. Jude Children’s Research Hospital, Department of Infectious Diseases, Memphis, TN
Principal Investigator: Gabriela Maron, MD
Coordinating Center Team:
Hailey Skonhovd, MPH – Project Coordinator
Jose Ferrolino, MD MPH – Data Manager/Analyst
Ronald Dallas, PhD – Coordinating Center Manager
Study Summary: As the novel coronavirus (Covid-19) pandemic continues to spread, understanding the epidemiology of the new virus will be crucial for developing effective prevention and treatment strategies. The COVID-19 clinical presentation is poorly defined in pediatric populations, as most of the reported known cases are adults. We aim to describe the epidemiology, clinical presentation and management, as well as the outcomes associated with COVID-19 among pediatric patients across the United States of America. To address these aims, we will conduct a secondary data use study among pediatric centers coordinated by the Pediatric Infectious Diseases Transplant Network (PIDTRAN) coordinating center housed at St. Jude. Deidentified data relating to risk factors, treatment, and outcomes among Covid-19 pediatric cases will be entered by sites into a REDCap database housed at St. Jude. No PHI will be entered in database or shared with the coordinating center.
Study Design: Observational, surveillance study utilizing secondary data originally collected for standard of care
Primary Objective: To describe the epidemiology, clinical presentation, risk factors, treatment and outcomes of pediatric patients with COVID-19 across the United States of America.
Secondary Objectives: (1) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in HCT pediatric patients with COVID-19. (2) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in pediatric immunocompromised patients with COVID-19. (3) To describe the epidemiology, clinical presentation, risk factors, treatment, and outcomes in the general pediatric population with COVID-19.
Eligibility: Pediatric patients (< 21 years old at the time of Covid-19 diagnosis) in the United States who are Covid-19 positive.
Data Collection Methods:
- Sites will abstract information from patients’ medical records that was originally collected for clinical care.
- De-identified demographic, clinical and outcome data will be entered into a REDCap survey hosted by St. Jude Children’s Research. PHI will not be entered in the survey nor will it be shared with the coordinating center.
- Sites will not have access to other participating site data.
Confidentiality:
- No PHI will be entered into the REDCap survey. The survey will only contain de-identified data in accordance with HIPAA Safe Harbor De-Identification standards.
- The study survey is hosted at the secure St. Jude Children’s Research Hospital data center. The REDCap servers are guarded by multiple firewall and intrusion detection systems. All electronic connections are encrypted. Access to all study data is restricted to delegated study staff at the coordinating center.
- De-identified data summaries will be available on the study website. These summaries will not identify individual centers.
Risk Benefit Analysis: This secondary data use study will not confer any additional risks to patients entered in the study survey. The only risk to patients is breach of confidentiality. Sites will access patient records containing PHI to enter information into the study survey. To minimize this risk as much as possible, no PHI will be entered in the study survey and sites will not share any PHI with other sites or the coordinating center. There is no benefit to patients entered in the study survey; however, future patients diagnosed with Covid-19 may benefit from the information learned from this study.
Consent Waiver: This study meets Category 4 - §46.104(d)(4), which is secondary research for which consent is not required.
Dissemination of Results:
- Aggregate de-identified data will be summarized and reported to pediatric centers routinely via the study website and email.
- De-identified data will also be used for peer reviewed journal publications.
Access to the data:
- Access to the raw data is restricted to the coordinating center staff at St. Jude Children’s Research Hospital. The coordinating center will release aggregate de-identified data summary reports.
- Investigators wishing to request access to the data for research not related to this study should contact the coordinating center. A separate IRB application may be required.
IRB Exemption Categories:
Category 4 - §46.104(d)(4) - Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.
St. Jude Children’s Research Hospital IRB Approval Date: March 25, 2020
Per the IRB approval letter: We have determined that the other sites providing clinical (NON-HIPAA identifiable) data to this project are NOT engaged in human subjects activities based on OHRP's October 16, 2008 “Guidance on Engagement of Institutions in Human Subjects Research”. Therefore, their role in the project does NOT need local IRB approval at their sites unless local policy dictates otherwise.
For further information, please contact: [email protected].