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COVID-19 Survivorship Registry

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ClinicalTrials.gov Identifier: NCT04527315
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.

Condition or disease Intervention/treatment
Covid19 Other: Questionnaires

Detailed Description:
The objectives for this study include providing structural and function information about lung and heart using chest imaging, MRI, Echo, Spirometry, and blood markers in order to assess severity of cardiopulmonary injury and short- and long-term sequelae of COVID-19 infection as well as assess indicators of mental health and quality of life.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database
Actual Study Start Date : July 17, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
COVID-19 ICU Patients Other: Questionnaires
Various questionnaires will be used to assess short and long-term impacts of depression, anxiety, and other indicators of overall mental health and quality of life
Control Other: Questionnaires
Various questionnaires will be used to assess short and long-term impacts of depression, anxiety, and other indicators of overall mental health and quality of life


Outcome Measures
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Primary Outcome Measures :
  1. Level of Inflammatory Markers [ Time Frame: Up to 12 months ]
    Inflammatory markers include D-dimer, ferritin, and CRP measurements


Secondary Outcome Measures :
  1. Score on St. George's Shortness of Breath Questionnaire (SGSQ) [ Time Frame: Up to 12 months ]
    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

  2. Score on Short Form Zarit Burden Interview (ZBI-12) [ Time Frame: Up to 12 months ]
    Short form ZBI-12 validated as screening tool in advanced illness including dementia and cancer. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48). The higher the score, the higher the burden.


Biospecimen Retention:   Samples With DNA
Blood will be tested for cytokine levels, inflammatory markers and genetics.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had a positive COVID-19 test, but were not hospitalized/admitted will also be identified and eligible to participate in the study. Age and sex matched controls will also be recruited from those with no clinical history of COVID-19.
Criteria

Inclusion Criteria:

  • have tested positive for SARS-CoV-2 and discharged from the ICU or,
  • have tested positive for SARS-CoV-2 and have been discharged from hospital or,
  • have tested positive for SARS-CoV-2 but was NOT hospitalized
  • ages 18 and over, and
  • competent and willing to sign informed consent and comply to all aspects of the protocol

CONTROL Inclusion Criteria

  • No clinical history of COVID-19,
  • No active clinical symptoms indicative of possible COVID-19,
  • Ages 18 and over,
  • competent and willing to sign informed consent and comply to all aspects of the protocol

Exclusion Criteria:

• Participants cannot sign consent

Any individual who meets any of the following criteria will be excluded from participation to the MRI or x-ray portion of the study:

  • Participants who are pregnant or currently trying to get pregnant
  • Participants unable to comply with any portion of the protocol (i.e. removing metals prior to entering the MRI scan room) or who have contraindications to MRI scanning (i.e., non-MRI-conditional pacemakers/defibrillators, pregnancy, ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
  • Persistent symptoms related to COVID-19 (in which case the patient may be re-screened later) As is done for all patients undergoing clinical MRI in our department, each patient will be screened for contraindications to MRI with a routine questionnaire prior to scanning.

CONTROL Exclusion Criteria

Patients with any of the following are excluded from as controls:

  • Pace maker
  • Poorly controlled diabetes
  • Poorly controlled Restrictive lung disease
  • Heart failure
  • Parkinson's Disease
  • Hypertension
  • Any diagnosis or history of autonomic neuropathy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04527315


Contacts
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Contact: Raveena Vakil 212-263-8119 Raveena.vakil@nyulangone.org
Contact: Ashley Witzl 212-263-1208 Ashley.witzl@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ellen Hada    646-501-0022    Covid-19survivorship@nyulangone.org   
Contact: Ashley Witzl    2122631208    Ashley.witzl@nyulangone.org   
Principal Investigator: Rany Condos, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Rany Condos, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04527315    
Other Study ID Numbers: 20-00909
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to covid-19survivorship@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No