Real World Study of COVID-19 in a Flyover Region

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.

Study Overview

• Status: Completed
• Conditions: Covid19

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 Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COVID-19 infected patients who received remdesivir to be compared to those who did not receive remdesivir.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Day 1 to Day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality during admission	Mortality rate change during admission compared between RDV vs non-RDV subjects	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	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	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	6 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Arnaud Drouin, MD, PhD, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Remdesivir
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes