Pediatrics HOT COVID-19 Database in NY Tristate

Columbia University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04445402

AAAT0268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

77 participants in 5 patient groups

Heme/Non-Sickle Cell Disease

Description:

Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease

Heme/Sickle Cell Disease

Description:

Subjects with a diagnosis of Sickle Cell Disease

Neuro-Oncological Disease

Description:

Oncology diagnosis with involvement of the neurological system

Oncology/Non-Neuro-Oncological

Description:

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

Transplant patients

Description:

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