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COVID-19 Survivorship Registry

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04527315
Collaborator
(none)
350
Enrollment
1
Location
60.5
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
350 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database
Actual Study Start Date :
Jul 17, 2020
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Level of Inflammatory Markers [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Rany Condos, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04527315
Other Study ID Numbers:
  • 20-00909
First Posted:
Aug 26, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Apr 27, 2022