561 - Safety of Remdesivir vs Standard Care in Patients with Moderate Covid-19

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Presenting Author(s)

GC

Gerard J. Criner

Critical Care Medicine Specialist
Temple University Hospital
Philadelphia, Pennsylvania
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator)

Co-Author(s)

MA

Mi Young Ahn

Investigator
Seoul Medical Center
Seoul, California
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
GH

Gregory Huhn

Practicing Physician
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)Janssen (Grant/Research Support)Proteus (Grant/Research Support)US National Institutes of Health (Grant/Research Support)Viiv Healthcare (Grant/Research Support)
AS

Aruna Subramanian

Clinical Professor
Stanford University
Palo Alto, California
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
CL

Carlos Lumbreras

Investigator
Hospital Universitario 12 de Octubre
Madid, Madrid, Spain
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
SS

Stefan Schmiedel

Investigator
I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, Hamburg, Germany
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)
VS

Vithika Suri

Sr Clinical Research Scientist I
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)
HW

Hongyuan Wang

Manager, Biostatistics
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)
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)
YC

Yao-Shen Chen

Investigator
Kaohsiung Veterans General Hospital
Kaohsiung, Kaohsiung
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
HG

Huldrych Günthard

Investigator
University Hospital Zurich
Zurich, Geneve, Switzerland
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
DS

D Jose Sanz-Moreno

Investigator
Hospital Universitario Principe de Asturias
Mardid, Madrid, Spain
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

Emanuele Nicastri

Investigator
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Rome, Emilia-Romagna, Italy
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
OT

Owen Tak-Yin Tsang

Investigator
Princess Margaret Hospital
Hong Kong, Hong Kong
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 safety of RDV in patients with moderate COVID-19.

Methods: We conducted an open-label, phase 3 trial (NCT04252664) in hospitalized patients with confirmed SARS-CoV-2 infection, evidence of pulmonary infiltrates, and oxygen saturation >94% on room air. Patients were randomly assigned to receive RDV (5 or 10 days) or standard of care (SOC). RDV was dosed intravenously at 200 mg on day 1, 100 mg daily thereafter. Adverse events (AEs) and laboratory abnormalities were evaluated through the day 11 data cut; safety data through day 28 will be presented at the meeting.

Results: 584 patients were randomized and treated (5d RDV: n=191; 10d RDV, n=193; SOC: n=200). Baseline characteristics were balanced among groups; median (range) age was 57y (12-95y), 39% were female and 19% Black, 39% had arterial hypertension, 15% hyperlipidemia, 11% asthma. Briefly, across both the 5d and 10d arms, RDV was well tolerated with a similar rate of Grade 3 or 4 AEs and fewer SAEs compared to SOC (Table). AEs more common with RDV vs SOC included nausea, headache, and hypokalemia. Overall, across the 3 arms, incidence of AEs leading to discontinuation and death were low and no clinically relevant changes in laboratory parameters were observed. In addition, median changes in renal and liver function tests from baseline were not statistically significant between the RDV 5d and RDV 10d groups compared to the SOC only group at d14 (Table 1).Table 1.

Conclusion: RDV given for 5d or 10d was well tolerated in patients with moderate COVID-19. No clinically significant safety signals were observed with RDV vs SOC.