Real World Study of COVID-19 in a Flyover Region

NCT04962347 | Completed

• 1 other identifier: 2021-112
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Remdesivir

Outcome Measures

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.

  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 Outcomes (4)

• Mortality during admission

  6 months

• Mortality at 6 months following symptom onset

  6 months

• Post-COVID-19 symptoms

  6 months

• Post-COVID-19 mortality

  6 months

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- None.

Sponsors & Collaborators

• Tulane University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arnaud Drouin, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: October 14, 2021
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)