COVID-19 Survivorship Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04527315 |
Recruitment Status :
Recruiting
First Posted : August 26, 2020
Last Update Posted : April 27, 2022
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Condition or disease | Intervention/treatment |
---|---|
Covid19 | Other: Questionnaires |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 350 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database |
Actual Study Start Date : | July 17, 2020 |
Estimated Primary Completion Date : | August 2025 |
Estimated Study Completion Date : | August 2025 |

Group/Cohort | Intervention/treatment |
---|---|
COVID-19 ICU Patients |
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 |
Control |
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 |
- Level of Inflammatory Markers [ Time Frame: Up to 12 months ]Inflammatory markers include D-dimer, ferritin, and CRP measurements
- Score on St. George's Shortness of Breath Questionnaire (SGSQ) [ Time Frame: Up to 12 months ]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.
- Score on Short Form Zarit Burden Interview (ZBI-12) [ Time Frame: Up to 12 months ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527315
Contact: Isabel Young | 929-455-5968 | isabel.young@nyulangone.org | |
Contact: Ashley Witzl | 212-263-1208 | Ashley.witzl@nyulangone.org |
United States, New York | |
NYU Langone Health | Recruiting |
New York, New York, United States, 10016 | |
Contact: Isabel Young 929-455-5968 isabel.young@nyulangone.org | |
Contact: Ashley Witzl 2122631208 Ashley.witzl@nyulangone.org | |
Principal Investigator: Rany Condos, MD |
Principal Investigator: | Rany Condos, MD | NYU Langone Health |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT04527315 |
Other Study ID Numbers: |
20-00909 |
First Posted: | August 26, 2020 Key Record Dates |
Last Update Posted: | April 27, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request. |
Supporting Materials: |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |