548 - Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19

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Presenting Author(s)

AC

Antonella Castagna

Investigator
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Milano, Lombardia, Italy
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)

Co-Author(s)

DS

David Shu Cheong Hui

Investigator
Chinese University of Hong Kong
Hong Kong, Hong Kong
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
Kathleen M. Mullane

Professor of Medicine Attending, Transplant Infectious Diseases Service
University of Chicago
Chicago, Illinois
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)
Mamta K. Jain

Professor
UT Southwestern Medical Center
Dallas, Texas
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator, Research Grant or Support)GlaxoSmithKline (Advisor or Review Panel member)Janssen (Research Grant or Support)Merck (Research Grant or Support)
MG

Massimo Galli

Investigator
Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, ASST Fatebenfratelli Sacco Ospedale Luigi Sacco
Milano, Lombardia, Italy
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Other Financial or Material Support, Personal fees)
SC

Shan-Chwen Chang

Professor
National Taiwan University Hospital
Taipei, Taipei, Taiwan (Republic of China)
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
RH

Robert H. Hyland

Sr Director, Virology Clinical Research
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
DS

Devi SenGupta

Sr Director, Clinical Research (MD)
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
HC

Huyen Cao

Sr Director, Virology Clinical Research
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
HH

Hailin Huang

Manager, Biostatistics
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
AC

Anand Chokkalingam

Clinical Research
Gilead
Foster City, California
Disclosure: Gilead Sciences (Employee)
AO

Anu Osinusi

Clinical Research
Gilead
Foster City, California
Disclosure: Gilead Sciences (Employee)
Diana M. Brainard

SVP, Therapeutic Area Head, Virology
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee)
CL

Christoph Lübbert

Investigator
Klinikum St. Georg Klinik für Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
Leipzig, Hessen, Germany
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
DC

David Chien Boon Lye

Investigator
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, Singapore
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
JA

Judith A. Aberg

Chief of Division of Infectious Diseases
Icahn School of Medicine at Mount Sinai
New York, New York
Disclosure: Theratechnology (Consultant)
EN

Enrique Navas Elorza

Investigator
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
KT

Karen T. Tashima

Professor of Medicine
Warren Alpert Medical School of Brown University
Providence, RI
Disclosure: Bristol-Myers Squibb (Research Grant or Support)Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)GlaxoSmithKline (Research Grant or Support)Merck (Research Grant or Support)Tibotec (Research Grant or Support)Viiv Healthcare (Research Grant or Support)
MM

Mark McPhail

Senior Lecturer and Consultant
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)

Background: Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Here we report baseline characteristics associated with clinical improvement at day (d) 14.

Methods: We enrolled hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation >94% on room air, and radiological evidence of pneumonia. Patients were randomized 1:1:1 to receive 5d or 10d of intravenous RDV once daily plus standard of care (SoC), or SoC only. For this analysis, patients were followed through discharge, d14, or death. Baseline demographic and disease characteristics associated with clinical improvement in oxygen support (≥2-point improvement on a 7-category ordinal scale ranging from discharge to death) were evaluated using multivariable logistic regression methods.

Results: 584 patients were randomized and treated (5/10d RDV, n=384; SoC: n=200). 159 (27%) were ≥65y, 227 (39%) female, 328 (61%) white, 102 (19%) Asian, and 99 (19%) Black. 252 participants (43%) were enrolled in Europe, 260 (45%) North America (NA), and 72 (12%) in Asia. Most patients (483 [83%]) were not on supplemental oxygen but required medical care at baseline. In a multivariable model, 5/10d RDV was significantly positively associated with clinical improvement (adjusted odds ratio [OR] 1.69, 95% CI: 1.08, 2.65; p=0.0226). Significant covariables positively associated with clinical improvement included age < 65y (p< 0.0001) and region of treatment (Europe and NA vs Asia, p< 0.0001 each; Table); other examined factors were not significantly associated with clinical improvement, including gender, race, ethnicity, baseline oxygen support, duration of symptoms and hospitalization, obesity, and baseline transaminase levels.Table 1.

Conclusion: In moderate COVID-19 patients, after adjusting for treatment arm, age < 65y and region (NA vs Asia; Europe vs Asia) were associated with higher rates of clinical improvement. These observations recapitulate younger age as positive prognostic factor, and highlight the differences in the impact of the pandemic globally.