Clinical trial NCT04962347: Real World Study of COVID-19 in a Flyover Region
Official title: Real World Study of COVID-19 in a Flyover Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Remdesivir
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-07-15
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 infected patients who received remdesivir to be compared to those who did not receive remdesivir.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- None.

Primary outcomes:
measure: The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose.
timeFrame: Change from Day 1 to Day 11
Secondary outcomes:
measure: Mortality during admission
timeFrame: 6 months
measure: Mortality at 6 months following symptom onset
timeFrame: 6 months
measure: Post-COVID-19 symptoms
timeFrame: 6 months
measure: Post-COVID-19 mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Arnaud Drouin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: