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

NCT05467930 | Recruiting

• 1 other identifier: AAAT6079
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (2)

• Characterization of long-term COVID-19 sequelae

  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

  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

Study Arms (1)

Participant

Individuals who were positive for COVID-19 and visited CUIMC/ New York Presbyterian (NYP) Hospital

Other: Survey; Other: Medical History Review; Other: Sample Collection

Interventions

Survey OTHER

Survey completion by the participant to collect information about health and social experience

Participant

Medical History Review OTHER

Review of the participant's medical history at New York Presbyterian/Columbia University Irving Medical Center

Participant

Sample Collection OTHER

Collection of nasal and blood samples

Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood for local antibody test NYP/CUIMC * Research Lab: plasma and serum for storage * Midturbinate nasal swab for real-time PCR

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires; Specimen Handling

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Magdalena Sobieszczyk, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Delivette Castor, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Sobieszczyk, MD, MPH

CONTACT

(845) 372-5023; covid19idresearch@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: July 1, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)