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NCT Number: NCT04448145

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

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.

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Key information

Conditions

COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Lawrence Purpura, MD, MPH

SUB_INVESTIGATOR

Michael Yin, MD, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lawrence Purpura, MD, MPH

CONTACT

[email protected]

212-305-2220

Michael Yin, MD, MS

CONTACT

[email protected]

212-305-7185

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study 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

Acronym: C-PIC

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2020
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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