Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT04448145

Conditions

COVID-19

Corona Virus Infection

SARS-CoV 2

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

COVID-19

Corona Virus Infection

SARS-CoV 2

Study ID

NCT04448145

Start date

Mar 26, 2020

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples [ Time Frame: Up to 96 weeks ]
  • Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples [ Time Frame: Up to 96 weeks ]
  • Duration of SARS-CoV-2 viral persistence in semen samples [ Time Frame: Up to 96 weeks ]
  • Duration of SARS-CoV-2 viral persistence in breast milk samples [ Time Frame: Up to 96 weeks ]
  • Prevalence of cell immune responses [ Time Frame: Up to 96 Weeks ]
  • Duration of COVID-19 Symptoms [ Time Frame: Up to 96 weeks ]
  • Prevalence of post-viral sequelae [ Time Frame: Up to 96 weeks ]
  • Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures [ Time Frame: Up to 96 weeks ]

Central Contacts and Locations

Central contacts

Michael Yin, MD, MS

212-305-7185mty4@cumc.columbia.edu

Lawrence Purpura, MD, MPH

212-305-2220lp2745@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Michael Yin, MD, MS

More Information

Sponsor

Columbia University

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Novel Coronavirus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-05.