- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448145
Determinants of SARS-COV2 (COVID-19) Persistence After Convalescence (C-PIC)
July 19, 2022 updated by: Columbia University
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
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
325
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Yin, MD, MS
- Phone Number: 212-305-7185
- Email: mty4@cumc.columbia.edu
Study Contact Backup
- Name: Lawrence Purpura, MD, MPH
- Phone Number: 212-305-2220
- Email: lp2745@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Medical Center
-
Principal Investigator:
- Michael Yin, MD, MS
-
Sub-Investigator:
- Lawrence Purpura, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples
Time Frame: 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.
|
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 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
Time Frame: 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.
|
Up to 96 weeks
|
Duration of SARS-CoV-2 viral persistence in breast milk samples
Time Frame: 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.
|
Up to 96 weeks
|
Prevalence of cell immune responses
Time Frame: 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.
|
Up to 96 Weeks
|
Duration of COVID-19 Symptoms
Time Frame: 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.
|
Up to 96 weeks
|
Prevalence of post-viral sequelae
Time Frame: 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.
|
Up to 96 weeks
|
Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures
Time Frame: Up to 96 weeks
|
Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.
|
Up to 96 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Yin, MD, MS, Associate Professor of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
- van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Bergantz L, Subra F, Deprez E, Delelis O, Richetta C. Interplay between Intrinsic and Innate Immunity during HIV Infection. Cells. 2019 Aug 17;8(8):922. doi: 10.3390/cells8080922.
- 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.
- Severe acute respiratory syndrome (SARS). Wkly Epidemiol Rec. 2003 Mar 21;78(12):81-3. No abstract available. English, French.
- Chan KH, Poon LL, Cheng VC, Guan Y, Hung IF, Kong J, Yam LY, Seto WH, Yuen KY, Peiris JS. Detection of SARS coronavirus in patients with suspected SARS. Emerg Infect Dis. 2004 Feb;10(2):294-9. doi: 10.3201/eid1002.030610.
- Corman VM, Albarrak AM, Omrani AS, Albarrak MM, Farah ME, Almasri M, Muth D, Sieberg A, Meyer B, Assiri AM, Binger T, Steinhagen K, Lattwein E, Al-Tawfiq J, Muller MA, Drosten C, Memish ZA. Viral Shedding and Antibody Response in 37 Patients With Middle East Respiratory Syndrome Coronavirus Infection. Clin Infect Dis. 2016 Feb 15;62(4):477-483. doi: 10.1093/cid/civ951. Epub 2015 Nov 12.
- Haak BW, Littmann ER, Chaubard JL, Pickard AJ, Fontana E, Adhi F, Gyaltshen Y, Ling L, Morjaria SM, Peled JU, van den Brink MR, Geyer AI, Cross JR, Pamer EG, Taur Y. Impact of gut colonization with butyrate-producing microbiota on respiratory viral infection following allo-HCT. Blood. 2018 Jun 28;131(26):2978-2986. doi: 10.1182/blood-2018-01-828996. Epub 2018 Apr 19.
- PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.
- Kurscheidt FA, Mesquita CSS, Damke GMZF, Damke E, Carvalho ARBA, Suehiro TT, Teixeira JJV, da Silva VRS, Souza RP, Consolaro MEL. Persistence and clinical relevance of Zika virus in the male genital tract. Nat Rev Urol. 2019 Apr;16(4):211-230. doi: 10.1038/s41585-019-0149-7.
- Den Boon S, Marston BJ, Nyenswah TG, Jambai A, Barry M, Keita S, Durski K, Senesie SS, Perkins D, Shah A, Green HH, Hamblion EL, Lamunu M, Gasasira A, Mahmoud NO, Djingarey MH, Morgan O, Crozier I, Dye C. Ebola Virus Infection Associated with Transmission from Survivors. Emerg Infect Dis. 2019 Feb;25(2):249-255. doi: 10.3201/eid2502.181011. Epub 2019 Feb 17.
- Jacobs M, Rodger A, Bell DJ, Bhagani S, Cropley I, Filipe A, Gifford RJ, Hopkins S, Hughes J, Jabeen F, Johannessen I, Karageorgopoulos D, Lackenby A, Lester R, Liu RS, MacConnachie A, Mahungu T, Martin D, Marshall N, Mepham S, Orton R, Palmarini M, Patel M, Perry C, Peters SE, Porter D, Ritchie D, Ritchie ND, Seaton RA, Sreenu VB, Templeton K, Warren S, Wilkie GS, Zambon M, Gopal R, Thomson EC. Late Ebola virus relapse causing meningoencephalitis: a case report. Lancet. 2016 Jul 30;388(10043):498-503. doi: 10.1016/S0140-6736(16)30386-5. Epub 2016 May 18.
- Soka MJ, Choi MJ, Baller A, White S, Rogers E, Purpura LJ, Mahmoud N, Wasunna C, Massaquoi M, Abad N, Kollie J, Dweh S, Bemah PK, Christie A, Ladele V, Subah OC, Pillai S, Mugisha M, Kpaka J, Kowalewski S, German E, Stenger M, Nichol S, Stroher U, Vanderende KE, Zarecki SM, Green HH, Bailey JA, Rollin P, Marston B, Nyenswah TG, Gasasira A, Knust B, Williams D. Prevention of sexual transmission of Ebola in Liberia through a national semen testing and counselling programme for survivors: an analysis of Ebola virus RNA results and behavioural data. Lancet Glob Health. 2016 Oct;4(10):e736-43. doi: 10.1016/S2214-109X(16)30175-9. Epub 2016 Aug 30. Erratum In: Lancet Glob Health. 2016 Nov;4(11):e793.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2020
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (Actual)
June 25, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS9722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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