COVID-19 Survivorship Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 ICU Patients<br> | Other: Questionnaires<br>* 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<br>|
| Control<br> | Other: Questionnaires<br>* 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<br>|

What is the study measuring?
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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 |