Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
1 other identifier
observational
2,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2020
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 19, 2026
May 1, 2026
7.7 years
June 18, 2021
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
2 Years
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.
3 Months
Secondary Outcomes (7)
Post-COVID symptoms onset at 6 months
6 months
Post-COVID symptoms onset at 9 months
9 months
Post-COVID symptoms onset at 12 months
12 months
Post-COVID symptoms onset at 15 months
15 months
Post-COVID symptoms onset at 18 months
18 months
- +2 more secondary outcomes
Study Arms (2)
Population 1
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. If so, a trained member of the study team will describe the study in person or by telephone. Community members who see the study flyer will also be able to reach out to the study team to learn more about the study and to find out if they meet eligibility criteria. If the eligible patient / legally authorized representative / legal guardian would like to participate. The verbal informed consent / verbal HIPAA, assent, and/or parental permission (as appropriate) will then be obtained in person.
Population 2
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 significant exposure to a patient with COVID-19 (contact at a distance of less than 6 feet without personal protective equipment) and have remained asymptomatic for 14 days following exposure will be recruited. Candidates will be identified through initial enrollment in Population 1, or by clinicians who have been informed of the study but are not part of the study team. Then, the clinical care team will ask the patient if he/she is willing to be contacted by the study team. Community members who see the study flyer or are otherwise informed of the study will also be able to reach out to the study team. Additionally, individuals with no defined past COVID-19 infection, but the potential to have been exposed to, and mounted antibodies against, COVID-19 will also be enrolled in Population 2 for this study.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- None
- Population 2:
- 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)
- Patients with the following criteria:
- Aged under 6 months old
- Anemia (Hgb \<7)
- Platelet \<80
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tulane Universitylead
- Centers for Disease Control and Preventioncollaborator
- Gilead Sciencescollaborator
Study Sites (2)
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Biospecimen
The investigators are collecting blood, plasma, urine, stool, nasal swab, saliva and tears collection.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dahlene Fusco, MD, PhD
Tulane University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
July 9, 2021
Study Start
March 17, 2020
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 19, 2026
Record last verified: 2026-05