COVID-19NCT05467930
CU-COMMITS: COVID-19 Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes of SARS-CoV-2
An observational study of COVID-19 and SARS CoV 2 Infection, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection
- What is being tested?
- Survey, Medical History Review and Sample Collection
- How many people
- 1,520 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort of predominantly Black and Latinx participants and their households who sought testing and care at CUIMC beginning in March 2020.
Who may be able to join
- 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
- age 18 years and older
- having an electronic medical record at NYP
Show all 10Show fewer
- 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.
Who cannot join
- Index cases less than 18 years of age.
- Not COVID-19 diagnosed
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, SARS CoV 2 Infection
- Being tested
- Survey, Medical History Review, Sample Collection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey completion by the participant to collect information about health and social experience
Medical History ReviewOther
Review of the participant's medical history at New York Presbyterian/Columbia University Irving Medical Center
Sample CollectionOther
Collection of nasal and blood samples
| Study group | Role | What they receive |
|---|---|---|
| Participant | Individuals who were positive for COVID-19 and visited CUIMC/ New York Presbyterian (NYP) Hospital Receives: Other: Survey; Other: Medical History Review; Other: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At least 9 months after COVID-19 Diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Jul 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Magdalena Sobieszczyk, MD, MPH, Principal investigator, Columbia UniversityDelivette Castor, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467930
- Sponsor's protocol ID
- AAAT6079
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05467930
- Acronym / sponsor ID
- AAAT6079
- Conditions
- COVID-19, SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,520 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Other: Survey, Other: Medical History Review, Other: Sample CollectionIndividuals who were positive for COVID-19 and visited CUIMC/ New York Presbyterian (NYP) Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of predominantly Black and Latinx participants and their households who sought testing and care at CUIMC beginning in March 2020.
Key inclusion criteria (10 listed)
- 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
- age 18 years and older
Key exclusion criteria (2 listed)
- Index cases less than 18 years of age.
- Not COVID-19 diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey completion by the participant to collect information about health and social experience | Other | Participant |
| Medical History ReviewReview of the participant's medical history at New York Presbyterian/Columbia University Irving Medical Center | Other | Participant |
| Sample CollectionCollection of nasal and blood samples | Other | Participant |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Sobieszczyk, MD, MPH principal investigator
Columbia University
Delivette Castor, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS CoV 2 Infection, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of long-term COVID-19 sequelae (time frame: At least 9 months after COVID-19 Diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.