Pediatrics HOT COVID-19 Database in NY Tristate

NCT ID: NCT04445402

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2022-09-12

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer Immune System Disorder COVID-19 Hemoglobinopathies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Heme/Non-Sickle Cell Disease

Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease

No interventions assigned to this group

Heme/Sickle Cell Disease

Subjects with a diagnosis of Sickle Cell Disease

No interventions assigned to this group

Neuro-Oncological Disease

Oncology diagnosis with involvement of the neurological system

No interventions assigned to this group

Oncology/Non-Neuro-Oncological

Subjects with any oncology diagnosis except those that involve the neurological system.

No interventions assigned to this group

Transplant patients

Subjects who have received or are intending to have a stem cell transplant for treatment of disease.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prakash Satwani, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAT0268

Identifier Type: -

Identifier Source: org_study_id

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