COVID-19 Survivorship Registry

Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Sasha Basdeo; Phone Number: 929-455-5968; Email: sasha.basdeo@nyulangone.org
• Study Contact Backup: Name: Shruthy Shankar; Phone Number: 212-263-1212; Email: shruthy.shankar@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Rany Condos, MD
      • Contact: Sasha Basdeo; Phone Number: 929-455-5968; Email: sasha.basdeo@nyulangone.org
      • Contact: Shruthy Shankar; Phone Number: 212-263-1212; Email: shruthy.shankar@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Inflammatory Markers	Inflammatory markers include D-dimer, ferritin, and CRP measurements	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on St. George's Shortness of Breath Questionnaire (SGSQ)	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.	Up to 12 months
Score on Short Form Zarit Burden Interview (ZBI-12)	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.	Up to 12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-00909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No