Pediatrics HOT COVID-19 Database in NY Tristate

NCT04445402 | Completed

• 1 other identifier: AAAT0268
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Immune System Disorder in Children; Immune System Disorder In Young Adults

Outcome Measures

Primary Outcomes (1)

• Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up

  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.

  One year

Secondary Outcomes (2)

• Change in PROMIS T-score

  Baseline, 3 Months, 6 Months

• Number of collected and analyzed stool samples

  Up to one year

Study Arms (5)

Heme/Non-Sickle Cell Disease

Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease

Heme/Sickle Cell Disease

Subjects with a diagnosis of Sickle Cell Disease

Neuro-Oncological Disease

Oncology diagnosis with involvement of the neurological system

Oncology/Non-Neuro-Oncological

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

Transplant patients

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

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children from birth to 21 years who have a hematologic, oncologic or stem cell transplant diagnosis and have been tested for COVID-19

You may qualify if:

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

You may not qualify if:

• Unwillingness to participate

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Optional stool specimens may be collected at three time points: 1) at diagnosis, 2) at resolution of COVID-19, 3) and at six months post-diagnosis.

MeSH Terms

Conditions

Neoplasms; Immune System Diseases; COVID-19; Hemoglobinopathies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Prakash Satwani, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: April 30, 2020
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

US (1)