Collecting COVID-19 virus secretions and serum for developing treatments
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
This study is collecting samples from people with COVID-19 to learn more about how the virus behaves and how it affects recovery, with the goal of improving treatments for those at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 6 Months to 120 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 2 sites (New Orleans, Louisiana and 1 other locations) |
| Trial ID | NCT04956445 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect SARS-CoV-2 secretions and serum from patients to understand the natural history of COVID-19 infections and characterize post-COVID morbidity. It focuses on analyzing immune responses, virus genome sequencing, cytokine responses, and virus shedding in both acutely infected and convalescent patients. The study will establish a data registry to track viral sequences and clinical courses, helping to identify predictors of severe outcomes and optimize treatment strategies for high-risk populations.
Who should consider this trial
Good fit: Ideal candidates include individuals who have tested positive for COVID-19 or other respiratory viruses and have either recovered or may have been exposed to COVID-19.
Not a fit: Patients under 6 months old or those with severe anemia or low platelet counts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better management of COVID-19 and its long-term effects.
How similar studies have performed: Other studies have shown success in characterizing immune responses and viral shedding in COVID-19, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Orleans, Louisiana and 1 other locations
- Tulane University Medical Center — New Orleans, Louisiana, United States (Recruiting)
- University Medical Center New Orleans — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Dahlene Fusco, MD, PhD — Tulane University School of Medicine
- Study coordinator: Dahlene Fusco, MD, PhD
- Email: dfusco@tulane.edu
- Phone: 504-988-7316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.