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NCT04956445 · ClinicalTrials.gov registry record
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
A clinical trial, sponsored by Tulane University.
- Recruiting
- Registry status
- 2,000
- Enrollment target
NCT04956445: Recruiting study, sponsored by Tulane University.
NCT04956445 is a clinical trial that is actively recruiting participants, run by Tulane University. The registered enrollment target is 2,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04956445 is actively recruiting participants, sponsored by Tulane University.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the clinical and laboratory risk factors which lead to severe vs non-severe COVID-19 clinical course in ambulatory patients. Severe COVID-19 cases defined as death or hospitalized on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO). Non-severe COVID-19 cases defined as hospitalized on non-invasive ventilation or high flow oxygen devices or requiring low flow supplemental oxygen (less than 15L) or not requiring supplemental oxygen, requiring ongoing med
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2020-03-17 |
| Est. Completion | 2027-12 |
What NCT04956445 shows while recruiting
NCT04956445 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT04956445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04956445 about?
NCT04956445 is a clinical study titled "Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development". 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 re...
What is the current status of trial NCT04956445?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2020-03-17. Estimated completion is 2027-12.
Who is sponsoring clinical trial NCT04956445?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
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