Covid19NCT04956445
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
An observational study of Covid19, run by Tulane University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2020to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
- 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)
Who cannot join
- None
- Population 2:
- Patients with the following criteria:
- Aged under 6 months old
- Anemia (Hgb <7)
- Platelet <80
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Tulane University Medical Center
New Orleans, Louisiana, 70112
Dahlene Fusco, MD, PhD, 504-988-7316, dfusco@tulane.edu
Dahlene Fusco, MD, PhD
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Dahlene Fusco, MD, PhD, 504-988-7316, dfusco@tulane.edu
Dahlene Fusco, MD, PhD
About this study
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:
- 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.
- 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.
Read the detailed description
The investigators are proposing two strategies to help mitigate COVID-19:
- 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.
- 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
- Develop a comparator group to determine whether immunomodulation induced by SARS CoV-2 differs from other respiratory viruses,
- Prepare for both routine seasonal and potential future influenza pandemic, which has been an ongoing concern for years now, and
- Expand their ability to monitor for potential intermixing of seasonal coronaviruses and SARS CoV-2, which could impact diagnostic tests for both.
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Data registry, Convalescent plasma, Post COVID-19, Post acute sequelae of COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Months
Secondary outcomes (7)
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 12 months
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.
Measured: 15 months
Post-COVID symptoms onset at 18 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 18 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.
Measured: 18 months
Post-COVID symptoms onset at 21 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 21 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.
Measured: 21 months
Post-COVID symptoms onset at 24 months
The proportion (in percentage) of the study cohort exhibiting post-COVID symptoms after recovering from COVID-19 at 24 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start17 Mar 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Dahlene Fusco, MD, PhD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956445
- Sponsor's protocol ID
- 2020-396
- Status last verified
- May 2026
- First submitted
- 18 Jun 2021
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
- ClinicalTrials.gov ID
- NCT04956445
- Acronym / sponsor ID
- 2020-396
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Data registry, Convalescent plasma, Post COVID-19, Post acute sequelae of COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Gilead Sciences
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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.
- 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
- Develop a comparator group to determine whether immunomodulation induced by SARS CoV-2 differs from other respiratory viruses,
- Prepare for both routine seasonal and potential future influenza pandemic, which has been an ongoing concern for years now, and
- Expand their ability to monitor for potential intermixing of seasonal coronaviruses and SARS CoV-2, which could impact diagnostic tests for both.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
- 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)
Key exclusion criteria (6 listed)
- None
- Aged under 6 months old
- Anemia (Hgb <7)
- Platelet <80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 clinically severe vs non severe cases
Time frame: 2 Years
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.
Post-COVID symptoms onset at 3 months
Time frame: 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.
7 secondary outcomes
Post-COVID symptoms onset at 6 months
Time frame: 6 months
Post-COVID symptoms onset at 9 months
Time frame: 9 months
Post-COVID symptoms onset at 12 months
Time frame: 12 months
Post-COVID symptoms onset at 15 months
Time frame: 15 months
Post-COVID symptoms onset at 18 months
Time frame: 18 months
Post-COVID symptoms onset at 21 months
Time frame: 21 months
Post-COVID symptoms onset at 24 months
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dahlene Fusco, MD, PhD principal investigator
Tulane University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Tulane University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dahlene Fusco, MD, PhD (504-988-7316, dfusco@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 clinically severe vs non severe cases (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.