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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Michael Yin, MD, MS
mty4@cumc.columbia.edu
212-305-7185
Backup
Lawrence Purpura, MD, MPH
lp2745@cumc.columbia.edu
212-305-2220
Time Frame
Start Date: 2020-03-26
Estimated Completion Date: 2025-10
Participants
Target number of participants: 800
Treatments
COVID-19 Positive
Participants who have been diagnosed with COVID-19 or experienced symptoms of COVID-19.
COVID-19 Negative
Participants who have never tested positive for COVID-19.
Related Therapeutic Areas
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov