Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence

NCT04448145 | Recruiting

• 1 other identifier: AAAS9722
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Keywords

Novel Coronavirus

Outcome Measures

Primary Outcomes (8)

• Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples

  Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR naso/oropharyngeal test, as determined by the established cycle threshold cut-off on a validated real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

  Up to 96 weeks

• Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples

  Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR stool or rectal swab samples, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

  Up to 96 weeks

• Duration of SARS-CoV-2 viral persistence in semen samples

  Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR semen sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

  Up to 96 weeks

• Duration of SARS-CoV-2 viral persistence in breast milk samples

  Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR breast milk sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

  Up to 96 weeks

• Prevalence of cell immune responses

  Prevalence defined as the number of participants with B cell, cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer (NK), and natural killer T (NKT) cell immune responses. Plasma will be used for evaluation of neutralizing and binding antibody titers to SARS-CoV-2.

  Up to 96 Weeks

• Duration of COVID-19 Symptoms

  The duration, in weeks, of COVID-19 symptoms as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.

  Up to 96 weeks

• Prevalence of post-viral sequelae

  Prevalence defined as the number of participants that develop post-viral sequelae as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.

  Up to 96 weeks

• Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures

  Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.

  Up to 96 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants with RT-PCR positive for SARS-CoV-2 or diagnosed empirically based on known exposure and symptoms of fever, cough, and shortness of breath. Empirically diagnosed individuals who are negative at baseline by RT-PCR and serology Immunoglobulin M (IgM)/Immunoglobulin G (IgG) will be classified as uninfected and will not participate further, but may be replaced. Negative participants with no known prior COVID-19 diagnosis or COVID-19 vaccine.

You 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 may not qualify if:

• Age \<7
• Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (16)

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• 2. New York State Department of Health. https://coronavirus.health.ny.gov/countycounty-breakdown-positive-cases. Accessed March 23, 2020

  BACKGROUND

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  BACKGROUND

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  PMID: 32182409 BACKGROUND

Related Links

• Columbia University Study Link and Eligibility Questionnaire

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, Nasal Swab, Blood, Stool, Semen, Breastmilk

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Yin, MD, MS

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Yin, MD, MS

CONTACT

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

Lawrence Purpura, MD, MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: March 26, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)