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Pediatrics HOT COVID-19 Database in NY Tristate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04445402
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Information provided by (Responsible Party):
Prakash Satwani, 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.

Condition or disease
Pediatric Cancer Immune System Disorder COVID-19 Hemoglobinopathies

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Retrospective and Prospective Database of COVID-19 Prevalence and Clinical Course in Pediatric and Young Adult Hematology/ Oncology/Stem Cell Therapy Patients in the New York Tri-State Area.
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

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
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.

Primary Outcome Measures :
  1. Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up [ Time Frame: 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 :
  1. Change in PROMIS T-score [ Time Frame: 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.

  2. Number of collected and analyzed stool samples [ Time Frame: 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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04445402

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Contact: Prakash Satwani, MD 212-305-0223
Contact: Jean Sosna, MS RN 212-305-2050

Show Show 17 study locations
Sponsors and Collaborators
Columbia University
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Principal Investigator: Prakash Satwani, MD Columbia University Irving Medical Center
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Responsible Party: Prakash Satwani, Associate Professor of Pediatrics at the Columbia University Medical Center, Columbia University Identifier: NCT04445402    
Other Study ID Numbers: AAAT0268
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prakash Satwani, Columbia University:
Immune System Disorder in Children
Immune System Disorder In Young Adults
Additional relevant MeSH terms:
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Immune System Diseases
Hematologic Diseases
Genetic Diseases, Inborn