NCT04956445

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 6 Months – 120 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigators are proposing two strategies to help mitigate COVID-19: 1. Establish active data registry for infected patients, which includes both sequence of viral isolate and clinical course. The purpose of this would be to determine whether sequences are evolving, which might affect planned countermeasures, and to evaluate which comorbidities/concurrent medications/clinical findings are the highest predictors for risk. This could allow us to better target screening and triage efforts, and potentially discontinue/substitute out medications that are worsening infection. For example, if diabetics confirm to be a particularly high risk they should potentially receive more rigorous screening, earlier admission, earlier medication optimization. For another example, there is some concern that patients with hypertension on angiotensin receptor blocking agents may have enhanced expression of Angiotensin Converting Enzyme (ACE-2), the entry receptor for SARS-CoV-2. If the investigators can confirm whether patients on Angiotensin Receptor Blocker (ARBs) have severe outcomes, this would justify the potential switch to alternate agents. Collect serum/plasma from convalescent patients. Patients who have been diagnosed with COVID-19 and have recovered (\>14 days since diagnosis) or individuals with no defined past COVID-19 infection, but the potential to have been exposed to (and mounted antibodies against) COVID-19 will provide a sample of whole blood, as well as other samples. 2. Determine long-term sequelae and pulmonary-related health outcomes for infected patients with COVID-19. Patients who survive infection with SARS Cov-2 are at risk of physical and psychological complications of lung injury. The investigators aim to determine the long-term sequelae of this infection. This would allow the investigators to better understand the long-term health impacts (physiological, functional, and quality-of-life) of this disease. Specifically, they aim to 1) conduct a systematic study of subjects post-COVID in order to determine which part(s) of that morbidity (clinical and laboratory) is caused by COVID, and 2) Identify predictors of post-COVID morbidity, including any protective role of treatments used during acute infection, and identify biomarkers (virus and host) that might be associated with severity/duration of the post-COVID syndrome. Overall, the investigators aim to define the entity of post-COVID morbidity, or post-acute sequelae of SARS-CoV-2 (PASC) so that they can then begin to explore methods to treat, and, ideally, prevent this morbidity. The investigators are expanding the criteria for inclusion in this study to other viruses in order to 1. Develop a comparator group to determine whether immunomodulation induced by SARS CoV-2 differs from other respiratory viruses, 2. Prepare for both routine seasonal and potential future influenza pandemic, which has been an ongoing concern for years now, and 3. Expand their ability to monitor for potential intermixing of seasonal coronaviruses and SARS CoV-2, which could impact diagnostic tests for both.

Conditions

• Covid19

Timeline

• Start date: 2020-03-17
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-07-09
• Last updated: 2023-12-21

Locations

2 sites across 1 country: United States