COVID-19 Survivorship Registry
ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Pace maker
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionVarious 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
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: COVID-19 ICU Patients1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
Level of Inflammatory Markers
Inflammatory markers include D-dimer, ferritin, and CRP measurements
Time frame
Up to 12 monthsSecondary outcomes
1
Score on St. George's Shortness of Breath Questionnaire (SGSQ)
Disease-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.
Time frame
Up to 12 months2
Score on Short Form Zarit Burden Interview (ZBI-12)
Short 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.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov