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COVID-19 Survivorship Registry

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04527315
Enrollment
1500
Registered
2020-08-26
Start date
2020-07-17
Completion date
2027-12-31
Last updated
2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

OTHERQuestionnaires

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of Inflammatory MarkersUp to 12 monthsInflammatory markers include D-dimer, ferritin, and CRP measurements

Secondary

MeasureTime frameDescription
Score on St. George's Shortness of Breath Questionnaire (SGSQ)Up to 12 monthsDisease-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 monthsShort 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.

Countries

United States

Contacts

Primary ContactAshley Witzl
PASCResearch@nyulangone.org212-263-1208
Backup ContactDaniel Walsh
Daniel.walsh@nyulangone.org929-573-0079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026