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Recruiting

NCT Number: NCT04527315

COVID-19 Survivorship Registry

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Level of Inflammatory Markers

    Time frame: Up to 12 months

    Inflammatory markers include D-dimer, ferritin, and CRP measurements

Secondary outcomes

  1. Score on St. George's Shortness of Breath Questionnaire (SGSQ)

    Time frame: 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.

  2. Score on Short Form Zarit Burden Interview (ZBI-12)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Witzl

CONTACT

[email protected]

212-263-1208

Daniel Walsh

CONTACT

[email protected]

929-573-0079

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2020
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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