COVID-19 Survivorship Registry

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527315
• Other study ID #: 20-00909
• Status: Recruiting
• Start date: July 17, 2020
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Sasha Basdeo
• Phone: 929-455-5968
• Email: sasha.basdeo[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Inflammatory Markers	Inflammatory markers include D-dimer, ferritin, and CRP measurements	Up to 12 months
Secondary	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
Secondary	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