What this study is
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.
Study details
- Official title
- Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases
- Sponsor
- Columbia University
- Conditions
- COVID-19 · Corona Virus Infection · SARS-CoV 2
- Enrolling
- 800 people
- Starts
- 2020-03-26
- Est. completion
- 2027-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Age <7
- Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openColumbia University Medical Center
New York, New York, United States
- Michael Yin, MD, MS · Principal investigator
- Lawrence Purpura, MD, MPH · Sub-investigator
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAS9722
Principal investigator
Michael Yin, MD, MS
Associate Professor of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.