NCT04448145 Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
| NCT ID | NCT04448145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2020-03-26 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2020-03-26 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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). * 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.
Contact & Investigator
Michael Yin, MD, MS
PRINCIPAL INVESTIGATOR
Associate Professor of Medicine
Frequently Asked Questions
Who can join the NCT04448145 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04448145 currently recruiting?
Yes, NCT04448145 is actively recruiting participants. Contact the research team at mty4@cumc.columbia.edu for enrollment information.
Where is the NCT04448145 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04448145 clinical trial?
NCT04448145 is sponsored by Columbia University. The principal investigator is Michael Yin, MD, MS at Associate Professor of Medicine. The trial plans to enroll 800 participants.
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