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

Tulane University · with Centers for Disease Control and Prevention, Gilead Sciences · NCT04956445

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6 mo–120 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2000
US sites recruiting
2
Study start
March 17, 2020
Record last updated
May 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • 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.
  • 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.

Conditions: Covid19

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Population 1:

Inclusion Criteria

  • 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)

Exclusion Criteria

  • None

Population 2:

Inclusion Criteria

  • 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)

Exclusion Criteria

Patients with the following criteria

  • Aged under 6 months old
  • Anemia (Hgb \<7)
  • Platelet \<80

Recruiting US locations

  • Tulane University Medical Center

    New Orleans, LA 70112

    Site contact: Dahlene Fusco, MD, PhD · 504-988-7316 · dfusco@tulane.edu

  • University Medical Center New Orleans

    New Orleans, LA 70112

    Site contact: Dahlene Fusco, MD, PhD · 504-988-7316 · dfusco@tulane.edu

Study contacts (from the official record)

  • Dahlene Fusco, MD, PhD · 504-988-7316 · dfusco@tulane.edu
All healthy volunteers studies in Louisiana →
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for… (NCT04956445) | Bored Studies