CU-COMMITS: COVID-19 Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes of SARS-CoV-2

June 3, 2026 updated by: Columbia University

CU-COMMITS (Columbia University Addresses COVID-19 unMet MedIcal Needs to Transform liveS) Study: COVID-19 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1520

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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:

  1. age 18 years and older
  2. having an electronic medical record at NYP
  3. 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.
  4. Able to provide informed consent

Exclusion Criteria -

  1. Index cases less than 18 years of age.
  2. Not COVID-19 diagnosed

Inclusion Criteria - Objective 2 Participants:

  1. age 18 years and older
  2. having an electronic medical record at NYP
  3. 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
  4. Randomly selected: every 10th index case who was not hospitalized
  5. Able to provide informed consent AND
  6. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participant
Individuals who were positive for COVID-19 and visited CUIMC/ New York Presbyterian (NYP) Hospital
Other: Survey
Survey completion by the participant to collect information about health and social experience
Other: Medical History Review
Review of the participant's medical history at New York Presbyterian/Columbia University Irving Medical Center
Other: Sample Collection
Collection of nasal and blood samples

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Delivette Castor, PhD, Columbia University
  • Principal Investigator: Magdalena Sobieszczyk, MD, MPH, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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