Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (akaClinSeqSer) is an observational study to understand natural history of SARS-COV-2infections among special populations and characterise post-covid morbidity through immuneresponse, virus genome sequencing, cytokine response, and virus shedding. Given thedescriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) andsince 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 patientsare now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigatorswant to further clarify questions surrounding rational confinement duration andtherapeutic approach by collecting plasma of convalescent patients to identify optimalantibody titer by ELISA, specificity of naturally occurring inflammatory(protein/antibody and RNA) response, and possibly test in vitro antibody neutralizationactivity.
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.
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
Tulane University Medical Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Dahlene Fusco, MD, PhD
504-988-7316
dfusco@tulane.edu
Dahlene Fusco, MD, PhD, Principal Investigator
Tulane University School of Medicine