Clinical trial NCT05467930: CU-COMMITS: COVID-19 Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes of SARS-CoV-2
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
SARS CoV 2 Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-07-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of long-term COVID-19 sequelae
timeFrame: At least 9 months after COVID-19 Diagnosis
measure: Presence of antibody response and molecular characteristics of SARS-CoV-2
timeFrame: At least 9 months after COVID-19 Diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Magdalena Sobieszczyk, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Delivette Castor, PhD
role: PRINCIPAL_INVESTIGATOR
References: