- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05467930
CU-COMMITS: COVID-Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes of SARS-CoV-2
July 19, 2022 updated by: Columbia University
CU-COMMITS (Columbia University Addresses COVID-19 unMet MedIcal Needs to Transform liveS) Study: COVID-Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes of SARS-CoV-2
The purpose of this study is to describe the long-term health effects of COVID-19 in a population of mostly Black and Latinx individuals and their households who were diagnosed with COVID-19 at Columbia University Irving Medical Center.
In New York, the upper Manhattan and south Bronx communities neighboring Columbia University Irving Medical Center (CUIMC) have been two of the most impacted communities of the COVID-19 pandemic.
These neighborhoods are predominantly non-Hispanic black or African American and Latinx.
This study will invite people who tested positive for COVID-19 and/or were treated at Columbia University Irving Medical Center to: 1) take a survey to ask about current symptoms and any health problems and 2) ask permission to review COVID-related health history including COVID-19 testing results (from the medical record) since infection to learn about health effects after COVID-19 infection; 3) invite anyone in their household to take a survey; and 4) for up to 500 patients who were hospitalized for COVID, give the option of doing a nasal swab to test for SARS-CoV-2 virus and blood test to check for antibody up to 12 months after diagnosis, to compare how results are different 12 months after infection.
The goal is to learn about how the severity of person's infection in 2020 influences long term health effects and how others in their household are impacted by COVID-19.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to describe long-term outcomes of COVID-19 in a predominantly Black and Latinx community.
The investigators propose to recruit patients who were diagnosed with and/or treated for COVID-19 at CUIMC.
The investigators seek to characterize the long-term outcomes of the patients and their households.
The catchment community and patient population accessing CUIMC is predominantly Black and Latinx.
The investigators will approach individuals who were treated for COVID at CUIMC in order to: administer an online questionnaire to collect information about presence of long-term sequalae or complications after initial infection (mental health, cardiovascular, pulmonary, neurological, as well as impact on activities of daily of living); with participant's permission, obtain data from the electronic medical record about initial testing results, inflammatory markers, post-diagnosis events such as re-admissions, clinic visits, and treatments for cardiovascular, pulmonary, neurological complications related to COVID; the investigators will also invite interested household members to complete out a on-line questionnaire with an option to review their electronic medical record for information related to COVID-19 testing and diagnosis.
For a subset of individuals who were admitted to the hospital at the time of initial diagnosis the investigators will invite them to submit a follow-up nasal swab (for polymerase chain reaction (PCR) and sequencing) and blood sample (to measure antibodies) to assess for re-infection and change in the molecular epidemiology of the SARS-CoV-2.
The investigators hypothesize that the baseline clinical, serological and molecular responses to COVID-19 will be characterized by demographic markers such as age, sex, racial and ethnic identity of families and households.
Furthermore, the investigators hypothesize that baseline inflammatory and virologic phenotype of the individual (as defined by levels of plasma inflammatory markers and SARS-COV-2 viral load in nasopharyngeal swabs) will have an impact on clinical outcomes and overall status following infection and the investigators will examine the role of these factors in the cohort.
The investigators will partner with community based organizations and community stakeholders, to dissemination information about this study and to communicate results back to the communities.
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Magda Sobieszczyk, MD
- Phone Number: (845) 372-5023
- Email: covid19idresearch@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Contact:
- Tae Kim
- Phone Number: 845-372-5023
- Email: covid19idresearch@cumc.columbia.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cohort of predominantly Black and Latinx participants and their households who sought testing and care at CUIMC beginning in March 2020.
Description
Inclusion Criteria - Objective 1 Participants:
- age 18 years and older
- having an electronic medical record at NYP
- laboratory confirmed COVID-19 infection diagnosed at NYP/CUIMC after March 1, 2020 or were diagnosed at least 9 months prior to administration of the online questionnaire on long-term outcomes and sequelae.
- Able to provide informed consent
Exclusion Criteria -
- Index cases less than 18 years of age.
- Not COVID-19 diagnosed
Inclusion Criteria - Objective 2 Participants:
- age 18 years and older
- having an electronic medical record at NYP
- Hospitalized at NYP/CUIMC after March 1 2020, or at least 9 months prior to administration of the online questionnaire on long-term outcomes and sequelae
- Randomly selected: every 10th index case who was not hospitalized
- Able to provide informed consent AND
- Are willing to provide a nasal swab, blood sample in addition to completing the questionnaire.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participant
Individuals who were positive for COVID-19 and visited CUIMC/ New York Presbyterian (NYP) Hospital
|
Survey completion by the participant to collect information about health and social experience
Review of the participant's medical history at New York Presbyterian/Columbia University Irving Medical Center
Collection of nasal and blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of long-term COVID-19 sequelae
Time Frame: At least 9 months after COVID-19 Diagnosis
|
Sequelae will be defined through several sources; 1) as the prevalence and persistence of symptoms of COVID-19 at least three weeks after the onset of COVID symptom, as medically attended visits and 2) self-reported presence of symptoms from the electronic questionnaire conducted at 9-18 months after infection.
Sequelae from the electronic questionnaire will be defined several ways; 1) as a binary variable (yes/no), 2) as a linear variable measuring severity of symptoms across multiple organ systems, and 3) >2 symptoms self-reported.
|
At least 9 months after COVID-19 Diagnosis
|
Presence of antibody response and molecular characteristics of SARS-CoV-2
Time Frame: At least 9 months after COVID-19 Diagnosis
|
Presence of antibody responses and molecular characteristics of the virus as collected by blood samples and nasal swabs in a subset of patients (N=500).
|
At least 9 months after COVID-19 Diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Delivette Castor, PhD, Columbia University
- Principal Investigator: Magda Sobieszczyk, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
July 19, 2022
First Submitted That Met QC Criteria
July 19, 2022
First Posted (Actual)
July 21, 2022
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT6079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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