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Completed

NCT Number: NCT04962347

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality during admission

    Time frame: 6 months

    Mortality rate change during admission compared between RDV vs non-RDV subjects

  2. Mortality at 6 months following symptom onset

    Time frame: 6 months

    Mortality rate through end of study period (6 months following symptom onset) compared between RDV vs non-RDV subjects

  3. Post-COVID-19 symptoms

    Time frame: 6 months

    Impact measurement of acute COVID-19 RDV on post-COVID-19 symptoms/morbidity compared between RDV vs non-RDV subjects

  4. Post-COVID-19 mortality

    Time frame: 6 months

    Impact measurement of acute COVID-19 RDV on post-COVID-19 mortality compared between RDV vs non-RDV subjects

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Gilead Sciences

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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