The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is notknown how long after someone gets sick with COVID-19 and recovers that they can stillinfect other people. It is also not known how quickly people make antibodies against thevirus, which help clear infection from the body. The investigators will enroll 300 peoplewho had COVID-19 based on lab testing or confirmed exposure to participate. An additional25 participants who have never tested positive for COVID and have not had the vaccinewill be enrolled as negative controls. Participants will complete a survey at enrollment.The investigators will also collect blood, nose swab, saliva, stool, semen, and breastmilk to test for the virus. The investigators will ask participants to complete a surveyand give specimens up to 12 times over 24 months. This information will be used to studyhow long the virus can live in different parts of the body, antibody development, andpost-infectious complications. The investigators hope that this information will allowmedical and public health providers to make recommendations to better care for patientsin the convalescent phase of COVID-19 infection.
This is an observational prospective cohort study of confirmed cases of COVID-19
recruited from communities surrounding New York City. 325 participants will be recruited
from NewYork-Presbyterian (NYP)-Columbia hospital, the community using flyers and
snowball sampling, and by contacting participants who are already participating in a
Columbia University Irving Medical Center (CUIMC) COVID-19 related study and have given
consent to be contacted about participation in related research studies. Candidates will
be eligible to participate if they have received a laboratory confirmed diagnosis of
COVID-19 or were symptomatic and had a known contact with a confirmed case of COVID-19,
and are over the age of 7. Participants who were diagnosed empirically due to symptoms
and exposure yet test negative by Reverse transcription polymerase chain reaction
(RT-PCR) and serology at baseline will not be considered infected with SARS-CoV-2 and may
be excluded. Participants will be consented prior to participation in any study
activities and will be prospectively followed for 96 weeks. At baseline, an enrollment
survey will be administered that includes demographics, comorbidities, and
characteristics of their COVID-19 illness (e.g., exposure, symptom onset, symptom
duration, severity of symptoms) and will provide blood and host reservoir site samples.
Participants will be followed for a 24 month period after symptom onset, with a maximum
of 12 visits.
Inclusion Criteria:
- Laboratory confirmed SARS-CoV-2 using currently available laboratory testing
techniques (e.g.,RT-PCR, Immunoglobulin M (IgM) /IgG) or clinical history compatible
with a COVID-19 like illness(fever, cough, shortness of breath).
- Negative participants with no known prior COVID-19 diagnosis or COVID vaccine
- At least 7 years of age
- Participants are eligible to provide semen and breast milk samples if they are 18
years of age or older
Exclusion Criteria:
- Age <7
- Intercurrent conditions that in the opinion of the investigator would confound the
findings of the study.
Columbia University Medical Center
New York, New York, United States
Michael Yin, MD, MS
212-305-7185
mty4@cumc.columbia.edu
Lawrence Purpura, MD, MPH
212-305-2220
lp2745@cumc.columbia.edu
Michael Yin, MD, MS, Principal Investigator
Associate Professor of Medicine