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Determinants of SARS-COV2 (COVID-19) Persistence After Convalescence

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ClinicalTrials.gov Identifier: NCT04448145
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Columbia University

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 250 people who had COVID-19 based on lab testing to participate. 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 8 times over 6 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.

Condition or disease
COVID-19 Corona Virus Infection SARS-CoV 2

Detailed Description:
This is an observational prospective cohort study of confirmed cases of COVID-19 recruited from communities surrounding New York City. 250 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 24 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 6 month period after symptom onset, with a maximum of 8 visits.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
COVID-19
Participants who have been diagnosed with COVID-19 or experienced symptoms of COVID-19 for more than 7 days.



Primary Outcome Measures :
  1. Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples [ Time Frame: Up to 24 weeks ]
    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.

  2. Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples [ Time Frame: Up to 24 weeks ]
    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.

  3. Duration of SARS-CoV-2 viral persistence in semen samples [ Time Frame: Up to 24 weeks ]
    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.

  4. Duration of SARS-CoV-2 viral persistence in breast milk samples [ Time Frame: Up to 24 weeks ]
    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.

  5. Prevalence of cell immune responses [ Time Frame: Up to 24 Weeks ]
    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.

  6. Duration of COVID-19 Symptoms [ Time Frame: Up to 24 weeks ]
    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.

  7. Prevalence of post-viral sequelae [ Time Frame: Up to 24 weeks ]
    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.

  8. Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures [ Time Frame: Up to 24 weeks ]
    Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.


Biospecimen Retention:   Samples With DNA
Saliva, Nasal Swab, Blood, Stool, Semen, Breastmilk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448145


Contacts
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Contact: Michael Yin, MD, MS 212-305-7185 mty4@cumc.columbia.edu
Contact: Lawrence Purpura, MD, MPH 212-305-2220 lp2745@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Michael Yin, MD, MS         
Sub-Investigator: Lawrence Purpura, MD, MPH         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Michael Yin, MD, MS Associate Professor of Medicine
Additional Information:
Publications:
2. New York State Department of Health. https://coronavirus.health.ny.gov/countycounty-breakdown-positive-cases. Accessed March 23, 2020
3. WHO Coronavirus disease 2019, Situation Report-63
4. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html. Accessed March 23, 2020.

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT04448145    
Other Study ID Numbers: AAAS9722
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified patient data, including test results, may be shared with other researchers within Columbia University at the discretion of the Principal Investigator, and only when the Institutional Review Board (IRB) approval has been granted to allow for the sharing of such data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia University:
Novel Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases