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NCT04956445Recruiting

Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development

Source: ClinicalTrials.gov · Last updated 19 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
18 Jun 2021
Start date
17 Mar 2020
Primary completion date
Dec 2027
Lead sponsor
Tulane University
NCT number
NCT04956445

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From 17 Mar 2020 to the primary completion date, Dec 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Platelet \<80

Age

  • Aged under 6 months old

Other

  • None
    • Population 2:
  • Patients with the following criteria:
  • Anemia (Hgb \<7)

Who the study is looking for

  • Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus
  • Patient or legally authorized representative has provided verbal consent / verbal HIPAA (or parental permission form and assent form, as appropriate)
  • 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
  • Patient or legally authorized representative has signed informed consent (or parental permission form and assent form, as appropriate)

Criteria the registry did not label

  • Population 1:

Age in the registry: 6 months to 120 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tulane University Medical Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
University Medical Center New Orleans
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.