Covid19NCT04962347
Real World Study of COVID-19 in a Flyover Region
An observational study of Covid19, run by Tulane University at 1 site in United States.
Trial summary
Real world data are needed on remdesivir (RDV) efficacy in COVID-19, especially in the underserved populations of the United States (U.S.) Gulf Coast as initial clinical trials may not be representative of this population. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Covid19
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to 18 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 120 years
- All sexes
- Adult, Older adult
Study population: COVID-19 infected patients who received remdesivir to be compared to those who did not receive remdesivir.
Who may be able to join
- Positive qRT PCR for COVID-19 from a nasopharyngeal, nasal, or oropharyngeal swab or from bronchoalveolar lavage.
- Received RDV (cases) or did not receive RDV (controls).
- Age ≥ 18 years
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Medical Center
New Orleans, Louisiana, 70112
About this study
Real world data are needed on remdesivir (RDV) efficacy in COVID-19, especially in the underserved populations of the United States (U.S.) Gulf Coast as initial clinical trials may not be representative of this population. Specifically, regions such as New Orleans are 60% African American, a much greater proportion of African Americans than initial RDV studies. The main hypothesis is that a real world data based study will provide specific information related to RDV efficacy in COVID-19 patients from underserved / underrepresented populations of the U.S. Gulf Coast. The main goal of this study is to provide population-centered information related on RDV related to indication (stage of disease), dosing, monitoring, efficacy and contraindications for future COVID-19 patients in this underserved region.
Read the detailed description
This study involves extracting data from 10,000 patients with Polymerase Chain Reaction (qPCR) confirmed COVID-19 infection through electronic-charts of Tulane Medical Center and University Medical Center (New Orleans, Louisiana) and Doctors Hospital at Renaissance (DHR) system (Texas). According to the inclusion criteria below and spanning from September 2019 - December 2021 we predict to include 1500 RDV treated patients and 8500 non-treated comparators, all with COVID-19, through the Research Action for Health Network (REACHnet) (link: https://eco.reachnet.org) in partnership with the Louisiana Public Health Institute (LPHI).
Statistical plan:
Following anonymized data extraction, propensity score will be used to compare primary and secondary endpoints between matched COVID-19 infected patients who received RDV to those who did not receive RDV. Patients of both cohorts will be stratified by severity. Moderate and severe respiratory distress associated with COVID-19 are defined as per US-GS-540-5773 and US-GS-540-5774 clinical trials. Through the investigator's extensive Electronic Medical Record (EMR) data collection network including diverse underserved populations of the U.S. Gulf South, they will evaluate real world outcomes of RDV treatment for COVID-19. The 2 cohorts will be compared with focus upon respiratory distress evolution, co-morbidities and other illness associated/relevant to COVID-19 course during admission, post-discharge during convalescent period of up to 6 months, and documentation of pre-admission comorbidities in the 6 months pre-admit.
- Conditions
- Covid19
- Keywords
- Remdesivir
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose.
Clinical severity will be measured using 7-point ordinal scale (1 Death, 2 Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO), 3 Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4 Hospitalized, requiring low flow supplemental oxygen (less than 15L), 5 Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19 related or otherwise), 6 Hospitalized, not requiring oxygen-no longer requires ongoing medical care, 7 Not hospitalized. The improvement and change in clinical severity, from first RDV dose recorded as Day 1 to Day 11 is recorded.
Measured: Change from Day 1 to Day 11
Secondary outcomes (4)
Mortality during admission
Mortality rate change during admission compared between RDV vs non-RDV subjects
Measured: 6 months
Mortality at 6 months following symptom onset
Mortality rate through end of study period (6 months following symptom onset) compared between RDV vs non-RDV subjects
Measured: 6 months
Post-COVID-19 symptoms
Impact measurement of acute COVID-19 RDV on post-COVID-19 symptoms/morbidity compared between RDV vs non-RDV subjects
Measured: 6 months
Post-COVID-19 mortality
Impact measurement of acute COVID-19 RDV on post-COVID-19 mortality compared between RDV vs non-RDV subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start14 Oct 2021
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
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
- Retrospective
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Arnaud Drouin, MD, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962347
- Sponsor's protocol ID
- 2021-112
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2021
- Last updated
- 20 Oct 2022
- 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of COVID-19 in a Flyover Region
- ClinicalTrials.gov ID
- NCT04962347
- Acronym / sponsor ID
- 2021-112
- Conditions
- Covid19
- Keywords
- Remdesivir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 15 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.
Real world data are needed on remdesivir (RDV) efficacy in COVID-19, especially in the underserved populations of the United States (U.S.) Gulf Coast as initial clinical trials may not be representative of this population. Specifically, regions such as New Orleans are 60% African American, a much greater proportion of African Americans than initial RDV studies. The main hypothesis is that a real world data based study will provide specific information related to RDV efficacy in COVID-19 patients from underserved / underrepresented populations of the U.S. Gulf Coast. The main goal of this study is to provide population-centered information related on RDV related to indication (stage of disease), dosing, monitoring, efficacy and contraindications for future COVID-19 patients in this underserved region.
Detailed description
This study involves extracting data from 10,000 patients with Polymerase Chain Reaction (qPCR) confirmed COVID-19 infection through electronic-charts of Tulane Medical Center and University Medical Center (New Orleans, Louisiana) and Doctors Hospital at Renaissance (DHR) system (Texas). According to the inclusion criteria below and spanning from September 2019 - December 2021 we predict to include 1500 RDV treated patients and 8500 non-treated comparators, all with COVID-19, through the Research Action for Health Network (REACHnet) (link: https://eco.reachnet.org) in partnership with the Louisiana Public Health Institute (LPHI).
Statistical plan:
Following anonymized data extraction, propensity score will be used to compare primary and secondary endpoints between matched COVID-19 infected patients who received RDV to those who did not receive RDV. Patients of both cohorts will be stratified by severity. Moderate and severe respiratory distress associated with COVID-19 are defined as per US-GS-540-5773 and US-GS-540-5774 clinical trials. Through the investigator's extensive Electronic Medical Record (EMR) data collection network including diverse underserved populations of the U.S. Gulf South, they will evaluate real world outcomes of RDV treatment for COVID-19. The 2 cohorts will be compared with focus upon respiratory distress evolution, co-morbidities and other illness associated/relevant to COVID-19 course during admission, post-discharge during convalescent period of up to 6 months, and documentation of pre-admission comorbidities in the 6 months pre-admit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 infected patients who received remdesivir to be compared to those who did not receive remdesivir.
Key inclusion criteria (3 listed)
- Positive qRT PCR for COVID-19 from a nasopharyngeal, nasal, or oropharyngeal swab or from bronchoalveolar lavage.
- Received RDV (cases) or did not receive RDV (controls).
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- None.
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
The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose.
Time frame: Change from Day 1 to Day 11
Clinical severity will be measured using 7-point ordinal scale (1 Death, 2 Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO), 3 Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4 Hospitalized, requiring low flow supplemental oxygen (less than 15L), 5 Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19 related or otherwise), 6 Hospitalized, not requiring oxygen-no longer requires ongoing medical care, 7 Not hospitalized. The improvement and change in clinical severity, from first RDV dose recorded as Day 1 to Day 11 is recorded.
4 secondary outcomes
Mortality during admission
Time frame: 6 months
Mortality at 6 months following symptom onset
Time frame: 6 months
Post-COVID-19 symptoms
Time frame: 6 months
Post-COVID-19 mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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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. This study is not recruiting at the moment.
Arnaud Drouin, MD, PhD principal investigator
Tulane University
1 site 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 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose. (time frame: Change from Day 1 to Day 11). 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 20 Oct 2022.