Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05467930 |
| Other study ID # |
AAAT6079 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
May 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Columbia University |
| Contact |
Magda Sobieszczyk, MD |
| Phone |
(845) 372-5023 |
| Email |
covid19idresearch[@]cumc.columbia.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
