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Recruiting NCT04527315

COVID-19 Survivorship Registry

— Observational Covid19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Covid19. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other 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 measures

  • Level of Inflammatory Markers [Time frame: Up to 12 months]
Secondary outcome measures (2)
  • Score on St. George's Shortness of Breath Questionnaire (SGSQ) [Time frame: Up to 12 months]
  • Score on Short Form Zarit Burden Interview (ZBI-12) [Time frame: Up to 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT04527315 · 20-00909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗