Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT04527315

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Questionnaires

Study Details

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.

Conditions

Covid19

Study ID

NCT04527315

Start date

Jul 17, 2020

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID-19 ICU Patients

Control

Interventions

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

Primary outcome measure

  • Level of Inflammatory Markers [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Rany Condos, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-10-30.