Clinical trial NCT04956445: Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Official title: Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Keywords: SARS-CoV-2
Data registry
Convalescent plasma
Post COVID-19
Post acute sequelae of COVID-19
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Gilead Sciences
First posted: 2021-07-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population 1: Infected patients

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.

Population 2: Convalescent patients

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 a significant exposure to a patient with COVID-19 (contact at distance of less than 6 feet without personal protective equipment) and have remained asymptomatic for 14 days following exposure will be recruited.

Brief 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.

Eligibility 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

Primary outcomes:
measure: COVID-19 clinically severe vs non severe cases
timeFrame: 2 Years
measure: Post-COVID symptoms onset at 3 months
timeFrame: 3 Months
Secondary outcomes:
measure: Post-COVID symptoms onset at 6 months
timeFrame: 6 months
measure: Post-COVID symptoms onset at 9 months
timeFrame: 9 months
measure: Post-COVID symptoms onset at 12 months
timeFrame: 12 months
measure: Post-COVID symptoms onset at 15 months
timeFrame: 15 months
measure: Post-COVID symptoms onset at 18 months
timeFrame: 18 months
measure: Post-COVID symptoms onset at 21 months
timeFrame: 21 months
measure: Post-COVID symptoms onset at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Dahlene Fusco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: