COVID-19 Survivorship Registry

Recruiting

• Conditions: Covid19
• Interventions: Other: Questionnaires

• Registration Number: NCT04527315
• Lead Sponsor: NYU Langone Health

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-17
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Questionnaires	-
COVID-19 ICU Patients	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
Level of Inflammatory Markers	Up to 12 months	Inflammatory markers include D-dimer, ferritin, and CRP measurements

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States