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

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04448145
Collaborator
(none)
325
Enrollment
1
Location
25.2
Anticipated Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    This is an observational prospective cohort study of confirmed cases of COVID-19 recruited from communities surrounding New York City. 325 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 96 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 24 month period after symptom onset, with a maximum of 12 visits.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    325 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 :
    Mar 26, 2020
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    May 1, 2022

    Arms and Interventions

    ArmIntervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples [Up to 96 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 [Up to 96 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 [Up to 96 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 [Up to 96 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 [Up to 96 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 [Up to 96 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 [Up to 96 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 [Up to 96 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Columbia University Medical CenterNew YorkNew YorkUnited States10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Michael Yin, MD, MS, Associate Professor of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT04448145
    Other Study ID Numbers:
    • AAAS9722
    First Posted:
    Jun 25, 2020
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021