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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04448145
Status
Recruiting

Conditions

  • COVID-19
  • Corona Virus Infection
  • SARS-CoV 2

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 26, 2020
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: COVID-19 Positive
    Participants who have been diagnosed with COVID-19 or experienced symptoms of COVID-19.
  • Arm: COVID-19 Negative
    Participants who have never tested positive for COVID-19.

Primary Outcome Measure

Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples [ Time Frame: Up to 96 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Michael Yin, MD, MS (PRINCIPAL_INVESTIGATOR)
Lawrence Purpura, MD, MPH (SUB_INVESTIGATOR)

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