73 - Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir

Background: Remdesivir (RDV), a RNA polymerase inhibitor with potent in vitro activity against SARS-CoV-2, is the only treatment with demonstrated efficacy in shortening the duration of COVID-19. Here we report regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, as part of an open-label, randomized phase-3 trial establishing RDV treatment duration.

Methods: Hospitalized patients with oxygen saturation ≤94%, a positive SARS-CoV-2 PCR in the past 4 days and radiographic evidence of pneumonia were randomized 1:1 to receive 5d or 10d of intravenous RDV. We compared d14 clinical outcomes of patients from different geographical areas, as measured by mortality rates, change in clinical status from baseline (BL) on a 7-point ordinal scale and change in O2 requirements from BL. Based on previous analyses in compassionate use data showing region as an important predictor of outcome, Italy was examined separately from other regions.

Results: 397 patients were treated with RDV, of which 229 (58%) were in the US, 77 (19%) Italy, 61 (15% in Spain), 12 (3%) Republic of Korea, 9 (2%) Singapore, 4 (1%) Germany, 4 (1%) Hong Kong and 1 (< 1%) Taiwan. BL clinical status was worse in Italy compared to other regions (72% vs 17% requiring high-flow oxygen delivery or higher), and Italian patients were more likely to be male than patients from other regions (69% vs 63%). Overall results showed 5d RDV was as effective as 10d. Mortality at d14 was higher in Italy (18%) compared to all other countries except Italy (7%). Similarly, clinical improvement at d14, measured as ≥2-point increase in the ordinal scale, was lower in Italian patients (39%) compared to all other countries combined (64%).  (Fig.1).Figure 1. Change from Baseline in Clinical Status (measured on a 7-point Ordinal Scale) at d14.


Conclusion: Overall, our results demonstrate significant geographical differences in the clinical course of severe COVID-19 patients treated with RDV. We observed worse outcomes, such as increased mortality and lower rate of clinical improvement, in patients from Italy compared to other regions.

Presenting Author(s)

• 

  George Diaz, MD

  Section Chief, Infectious Diseases
  Providence Regional Medical Center Everett
  Everett, WA

  Disclosure: Gilead Sciences Inc. : Scientific Research Study Investigator; Lexicon Pharmaceuticals : Consultant (Status: Ongoing); Regeneron : Scientific Research Study Investigator

  Slides Slides and Audio

Co-Author(s)

• 

  Jose R. Arribas, MD

  Head of the Infectious Diseases Unit and Research Director of HIV and Infectious Diseases
  Hospital Universitario La Paz
  Madrid, Madrid, Spain

  Disclosure: NO DISCLOSURE DATA
• PR

  Philip A. Robinson, MD

  Physician
  Hoag Hospital
  Irvine, California

  Disclosure: NO DISCLOSURE DATA
• AC

  Anna Maria Cattelan, MD

  Investigator
  UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova
  Padova, Puglia, Italy

  Disclosure: NO DISCLOSURE DATA
• KT

  Karen T. Tashima, MD

  Clinical Research Site Leader
  The Miriam Hospital
  Providence, Rhode Island

  Disclosure: NO DISCLOSURE DATA
• OT

  Owen Tak-Yin Tsang, MD

  Investigator
  Princess Margaret Hospital
  Hong Kong, Hong Kong

  Disclosure: NO DISCLOSURE DATA
• YC

  Yao-Shen Chen, MD

  Investigator
  Kaohsiung Veterans General Hospital
  Kaohsiung, Kaohsiung

  Disclosure: NO DISCLOSURE DATA
• DS

  Devi SenGupta, MD

  Sr Director, Clinical Research (MD)
  Gilead Sciences Inc.
  Foster City, California

  Disclosure: NO DISCLOSURE DATA
• EV

  Elena Vendrame, MD

  Director, Virology Clinical Research
  Gilead Sciences Inc.
  Foster City, California

  Disclosure: NO DISCLOSURE DATA
• CB

  Christiana Blair, MS

  Director
  Gilead Sciences Inc.
  Foster City, California

  Disclosure: NO DISCLOSURE DATA
• AC

  Anand Chokkalingam, PhD

  Clinical Research
  Gilead
  Foster City, California

  Disclosure: NO DISCLOSURE DATA
• AO

  Anu Osinusi, MD

  Clinical Research
  Gilead
  Foster City, California

  Disclosure: NO DISCLOSURE DATA
• 

  Diana M. Brainard, MD

  SVP, Therapeutic Area Head, Virology
  Gilead Sciences Inc.
  Foster City, CA

  Disclosure: Gilead Sciences : Employee
• BC

  Bum Sik Chin, MD

  Investigator
  National Medical Center
  Seoul, California

  Disclosure: NO DISCLOSURE DATA
• CS

  Christoph Spinner, MD

  MD
  Department of Medicine II, University Hospital rechts der Isar, Technical University of Munich, Munich, Germany
  Munich, Bayern, Germany

  Disclosure: NO DISCLOSURE DATA
• GC

  Gerard J. Criner, MD

  Critical Care Medicine Specialist
  Temple University Hospital
  Philadelphia, Pennsylvania

  Disclosure: NO DISCLOSURE DATA
• JM

  Jose Muñoz, MD

  Investigator
  Hospital Clinic de Barcelona
  Barcelona, Andalucia, Spain

  Disclosure: NO DISCLOSURE DATA
• DC

  David Chien Boon Lye, MD

  Investigator
  National Centre for Infectious Diseases, Tan Tock Seng Hospital
  Singapore, Singapore

  Disclosure: NO DISCLOSURE DATA
• RG

  Robert L. Gottlieb, MD

  Practicing Physician
  Baylor University Medical Center
  Dallas, Texas

  Disclosure: NO DISCLOSURE DATA