RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-17
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04956445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus
  2. 2. Patient or legally authorized representative has provided verbal consent / verbal HIPAA (or parental permission form and assent form, as appropriate)
  1. * None

Contacts and Locations

Study Contact

Dahlene Fusco, MD, PhD
CONTACT
504-988-7316
dfusco@tulane.edu

Principal Investigator

Dahlene Fusco, MD, PhD
PRINCIPAL_INVESTIGATOR
Tulane University School of Medicine

Study Locations (Sites)

Tulane University Medical Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Dahlene Fusco, MD, PhD, PRINCIPAL_INVESTIGATOR, Tulane University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-17
Study Completion Date2025-03

Study Record Updates

Study Start Date2020-03-17
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Covid19