Pediatrics HOT COVID-19 Database in NY Tristate

Completed

• Conditions: COVID-19; Pediatric Cancer; Immune System Disorder; Hemoglobinopathies

• Registration Number: NCT04445402
• Lead Sponsor: Columbia University

Brief Summary

New York City (NYC) has become the epicenter of the worldwide pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). By collecting and summarizing the experience with other major health care providers in the tristate (New York (NY), New Jersey (NJ) and Connecticut (CT)) are, the investigators are uniquely positioned to inform the rest of the country about what to expect and how to manage children and young adults with hematological, oncological or stem cell transplant diagnoses during the pandemic.

Detailed Description

The subjects are all pediatric hematology, oncology or stem cell transplant (HOT) children and young adults who are tested for SARS-CoV-2. The investigators will collect data including demographics, clinical characteristics, clinical courses, outcomes from the medical record.

Other information about finances, mental health, and nutrition will be ascertained by questionnaires. The subjects will be asked to allow the researchers to abstract information from their medical record, participate in an interview or telephone call (their choice) to answer questionnaires, and to provide a stool sample at three time points.

The creation of an integrated database of COVID-19 pediatric and young adult patients will better inform the pediatric hematology, oncology, and stem cell transplant community about this disease specifically related to patients undergoing HOT therapy and provide valuable evidence to develop standardized and clinically appropriate approaches to their care.

Study Timeline

• Study Start: 2020-04-30
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Hematologic, Oncologic or Stem Cell Transplant Diagnosis
• Tested for COVID-19
• Age up to 21 years of age

Exclusion Criteria

• Unwillingness to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up	One year	To measure the success of the data registry in how many patients agreed to participate and completed the one year follow up. A confirmed case of COVID-19 is defined as a positive result on a reverse-transcriptase- polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab, or a serum antibody test. Only laboratory-confirmed cases will be described as positive.

Secondary Outcome Measures

Name	Time	Method
Number of collected and analyzed stool samples	Up to one year	To examine if the pandemic has effects on the patients' nutrition and microbiome. Each patient is given an opportunity to provide stool samples in addition to survey response.
Change in PROMIS T-score	Baseline, 3 Months, 6 Months	To analyze effect of COVID-19 on patients and their families mental health. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States