COVID-19 Survivorship Registry

NCT04527315 | Recruiting

• 1 other identifier: 20-00909
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Level of Inflammatory Markers

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

  Up to 12 months

Secondary Outcomes (2)

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

  Up to 12 months

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

  Up to 12 months

Study Arms (2)

COVID-19 ICU Patients

Other: Questionnaires

Control

Other: Questionnaires

Interventions

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

COVID-19 ICU Patients; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a positive COVID-19 test, but were not hospitalized/admitted will also be identified and eligible to participate in the study. Age and sex matched controls will also be recruited from those with no clinical history of COVID-19.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be tested for cytokine levels, inflammatory markers and genetics.

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rany Condos, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Witzl

CONTACT

212-263-1208; PASCResearch@nyulangone.org

Daniel Walsh

CONTACT

929-573-0079; Daniel.walsh@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: July 17, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to covid-19survivorship@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)