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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT04956445
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 120 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 17, 2020
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tulane University Medical CenterNew OrleansLouisiana70112
Dahlene Fusco, MD, PhD
[email protected]
504-988-7316
Dahlene Fusco, MD, PhD (PRINCIPAL_INVESTIGATOR)
University Medical Center New OrleansNew OrleansLouisiana70112
Dahlene Fusco, MD, PhD
[email protected]
504-988-7316
Dahlene Fusco, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By condition
COVID-19 / long COVID
By specialty
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By research site
Tulane University Medical Center· New Orleans, LAUniversity Medical Center New Orleans· New Orleans, LA

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