The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 300 people who had COVID-19 based on lab testing or confirmed exposure to participate. An additional 25 participants who have never tested positive for COVID and have not had the vaccine will be enrolled as negative controls. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 12 times over 24 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in 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