Recruiting

SARS-CoV-2 Investigation

Sponsor:

Tulane University

Code:

NCT04956445

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Covid19

Study ID

NCT04956445

Start date

Mar 17, 2020

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Population 1

Once a positive diagnosis of COVID-19 has been made in the clinical setting, the clinical team caring for the patient will ask the patient / family whether they would be willing to be contacted by the study team about the study. If so, a trained member of the study team will describe the study in person or by telephone. Community members who see the study flyer will also be able to reach out to the study team to learn more about the study and to find out if they meet eligibility criteria. If the eligible patient / legally authorized representative / legal guardian would like to participate. The verbal informed consent / verbal HIPAA, assent, and/or parental permission (as appropriate) will then be obtained in person.

Population 2

Persons with a history of past (>14 days ago) diagnosis of COVID-19 infection will be invited to participate in this study. In addition, persons who have had significant exposure to a patient with COVID-19 (contact at a distance of less than 6 feet without personal protective equipment) and have remained asymptomatic for 14 days following exposure will be recruited. Candidates will be identified through initial enrollment in Population 1, or by clinicians who have been informed of the study but are not part of the study team. Then, the clinical care team will ask the patient if he/she is willing to be contacted by the study team. Community members who see the study flyer or are otherwise informed of the study will also be able to reach out to the study team. Additionally, individuals with no defined past COVID-19 infection, but the potential to have been exposed to, and mounted antibodies against, COVID-19 will also be enrolled in Population 2 for this study.

Primary outcome measure

  • COVID-19 clinically severe vs non severe cases [ Time Frame: 2 Years ]
  • Post-COVID symptoms onset at 3 months [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Dahlene Fusco, MD, PhD

504-988-7316dfusco@tulane.edu

Locations

Tulane University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Dahlene Fusco, MD, PhD

504-988-7316dfusco@tulane.edu

Principal Investigator:

Dahlene Fusco, MD, PhD

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Dahlene Fusco, MD, PhD

504-988-7316dfusco@tulane.edu

Principal Investigator:

Dahlene Fusco, MD, PhD

More Information

Sponsor

Tulane University

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • SARS-CoV-2
  • Data registry
  • Convalescent plasma
  • Post COVID-19
  • Post acute sequelae of COVID-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-05-19.