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

RecruitingObservational studyHealthy volunteers welcome

Who can join

6 Months – 120 Years · All sexes · Healthy volunteers welcome

Full 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

About the study

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.

Sponsor: Tulane University · Participants: 2,000 · Started: Mar 17, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04956445

Locations in the U.S.

LouisianaTulane University Medical Center, New Orleans
University Medical Center New Orleans, New Orleans

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.