NCT04956445 Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
| NCT ID | NCT04956445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Covid19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-03-17 |
| Primary Completion | 2027-12 |
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 2,000 participants in total. It began in 2020-03-17 with a primary completion date of 2027-12.
⚠ 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
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide: 1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting/predictive of severity of disease and the latter reflecting extent/source of contagiosity. 2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear. Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity.
Eligibility Criteria
Population 1: Inclusion Criteria: 1. Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus 2. Patient or legally authorized representative has provided verbal consent / verbal HIPAA (or parental permission form and assent form, as appropriate) Exclusion Criteria: * None Population 2: Inclusion Criteria: 1. Positive diagnostic test for COVID-19 \>14 days prior, OR potential to have been exposed to (and mounted antibodies against) COVID-19, OR positive diagnostic test for influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus 2. Patient or legally authorized representative has signed informed consent (or parental permission form and assent form, as appropriate) Exclusion Criteria: Patients with the following criteria: * Aged under 6 months old * Anemia (Hgb \<7) * Platelet \<80
Contact & Investigator
Dahlene Fusco, MD, PhD
PRINCIPAL INVESTIGATOR
Tulane University School of Medicine
Frequently Asked Questions
Who can join the NCT04956445 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 120 Years, studying Covid19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04956445 currently recruiting?
Yes, NCT04956445 is actively recruiting participants. Contact the research team at dfusco@tulane.edu for enrollment information.
Where is the NCT04956445 trial being conducted?
This trial is being conducted at New Orleans, United States, New Orleans, United States.
Who is sponsoring the NCT04956445 clinical trial?
NCT04956445 is sponsored by Tulane University. The principal investigator is Dahlene Fusco, MD, PhD at Tulane University School of Medicine. The trial plans to enroll 2,000 participants.
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