Registry for COVID-19 survivors to assess lung and heart health

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

This study is trying to see how COVID-19 affects the lungs and heart in people who have recovered from the virus, while also looking at their mental health and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT04527315 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the cardiopulmonary effects of COVID-19 by conducting a longitudinal assessment of patients who have recently tested positive for the virus. Participants will undergo various imaging techniques, including chest imaging, MRI, and echocardiograms, along with spirometry and blood tests to measure the severity of lung and heart injury. Additionally, the study will assess mental health indicators and quality of life outcomes in these patients. The goal is to better understand both the short- and long-term consequences of COVID-19 infection on respiratory and cardiovascular health.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and over who have tested positive for SARS-CoV-2, regardless of hospitalization status.

Not a fit: Patients who have not had COVID-19 or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term health impacts of COVID-19, guiding better patient care and management strategies.

How similar studies have performed: Other studies have shown success in assessing the long-term effects of COVID-19, making this approach both relevant and necessary.

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

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Rany Condos, MD — NYU Langone Health
• Study coordinator: Ashley Witzl

Conditions Covid19