Clinical trial NCT04527315: COVID-19 Survivorship Registry
Official title: Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Level of Inflammatory Markers
timeFrame: Up to 12 months
Secondary outcomes:
measure: Score on St. George's Shortness of Breath Questionnaire (SGSQ)
timeFrame: Up to 12 months
measure: Score on Short Form Zarit Burden Interview (ZBI-12)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Rany Condos, MD
role: PRINCIPAL_INVESTIGATOR
References: