Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorColumbia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <7
Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 2 trial groupsGroup A: COVID-19 Positive
Group B: COVID-19 Negative
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 96 weeks2
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.
Time frame
Up to 96 weeks3
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.
Time frame
Up to 96 weeks4
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.
Time frame
Up to 96 weeksSponsors and contacts
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Source ClinicalTrials.gov