Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-120
SponsorTulane University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus
Patient or legally authorized representative has provided verbal consent / verbal HIPAA (or parental permission form and assent form, as appropriate)
Disqualifiers
None
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
Patient or legally authorized representative has signed informed consent (or parental permission form and assent form, as appropriate)
Aged under 6 months old
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: Population 1
Group B: Population 2
Trial outcomes
Primary outcomes
1
COVID-19 clinically severe vs non severe cases
To determine the clinical and laboratory risk factors which lead to severe vs non-severe COVID-19 clinical course in ambulatory patients. Severe COVID-19 cases defined as death or hospitalized on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO). Non-severe COVID-19 cases defined as hospitalized on non-invasive ventilation or high flow oxygen devices or requiring low flow supplemental oxygen (less than 15L) or not requiring supplemental oxygen, requiring ongoing medical care or no longer requires on going medical care or not hospitalized.
Time frame
2 Years2
Post-COVID symptoms onset at 3 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 3 months from initial date of symptom onset. Post-COVID symptoms which are all new since COVID infection are fatigue, tiredness or exhaustion, muscle aches/muscle pains, pain in joints, problems in sleep, forgetfulness/memory problems, difficulty thinking or concentrating, dizziness or fainting, fever, headache, nausea or abdominal pain, diarrhea, runny nose, sore throat, cough, shortness of breath/abnormal breathing, loss of smell, loss of taste, and inability to walk.
Time frame
3 MonthsSecondary outcomes
1
Post-COVID symptoms onset at 6 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 6 months from initial date of symptom onset. Post-COVID symptoms which are all new since COVID infection are fatigue, tiredness or exhaustion, muscle aches/muscle pains, pain in joints, problems in sleep, forgetfulness/memory problems, difficulty thinking or concentrating, dizziness or fainting, fever, headache, nausea or abdominal pain, diarrhea, runny nose, sore throat, cough, shortness of breath/abnormal breathing, loss of smell, loss of taste, and inability to walk.
Time frame
6 months2
Post-COVID symptoms onset at 9 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 9 months from initial date of symptom onset. Post-COVID symptoms which are all new since COVID infection are fatigue, tiredness or exhaustion, muscle aches/muscle pains, pain in joints, problems in sleep, forgetfulness/memory problems, difficulty thinking or concentrating, dizziness or fainting, fever, headache, nausea or abdominal pain, diarrhea, runny nose, sore throat, cough, shortness of breath/abnormal breathing, loss of smell, loss of taste, and inability to walk.
Time frame
9 months3
Post-COVID symptoms onset at 12 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 12 months from initial date of symptom onset. Post-COVID symptoms which are all new since COVID infection are fatigue, tiredness or exhaustion, muscle aches/muscle pains, pain in joints, problems in sleep, forgetfulness/memory problems, difficulty thinking or concentrating, dizziness or fainting, fever, headache, nausea or abdominal pain, diarrhea, runny nose, sore throat, cough, shortness of breath/abnormal breathing, loss of smell, loss of taste, and inability to walk.
Time frame
12 months4
Post-COVID symptoms onset at 15 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 15 months from initial date of symptom onset. Post-COVID symptoms which are all new since COVID infection are fatigue, tiredness or exhaustion, muscle aches/muscle pains, pain in joints, problems in sleep, forgetfulness/memory problems, difficulty thinking or concentrating, dizziness or fainting, fever, headache, nausea or abdominal pain, diarrhea, runny nose, sore throat, cough, shortness of breath/abnormal breathing, loss of smell, loss of taste, and inability to walk.
Time frame
15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Gilead Sciences
Collaborator
Source ClinicalTrials.gov