COVID-19C-PICNCT04448145
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
An observational study of COVID-19 and Corona Virus Infection, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- COVID-19, Corona Virus Infection, SARS-CoV 2
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2020to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <7
- Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Michael Yin, MD, MS
Lawrence Purpura, MD, MPH
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Corona Virus Infection, SARS-CoV 2
- Keywords
- Novel Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start26 Mar 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Yin, MD, MS, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448145
- Sponsor's protocol ID
- AAAS9722
- Acronym
- C-PIC
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 314265252. 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.
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.
PubMed 32031570Holshue 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.
PubMed 32004427Severe acute respiratory syndrome (SARS). Wkly Epidemiol Rec. 2003 Mar 21;78(12):81-3. No abstract available. English, French.
PubMed 12701272Chan 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.
PubMed 15030700Corman 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.
PubMed 26565003Haak 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.
PubMed 29674425PREVAIL 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.
PubMed 30855742Kurscheidt 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.
PubMed 30696994Den 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.
PubMed 30500321Jacobs 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.
PubMed 27209148Soka 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.
PubMed 27596037