536 - Clinical Outcomes of Hospitalized COVID-19 Patients Treated with Remdesivir- NEAT ID 909REM Study

Background: There are few real-world data on the use of remdesivir (RDV) looking at timing of initiation in relation to symptom onset and severity of presenting disease.

Methods:

We conducted multi-country retrospective study of clinical practice and use of RDV in COVID-19 patients. De-identified medical records data were entered into an e-CRF. Primary endpoints were all-cause mortality at day 28 and hospitalization duration. We assessed time from symptom onset to RDV start and re-admission. We included adults with PCR-confirmed symptomatic COVID-19 who were hospitalized after Aug 31, 2020 and received at least 1 dose of RDV. Descriptive analyses were conducted. Kaplan-Meier methods were used to calculate the mortality rate, LogRank test to compare groups defined by severity of disease. Competing risk regression with discharge and death as competing events was used to estimate duration of hospitalization, and Gray’s test to compare the groups.

Results:

448 patients in 5 countries (12 sites) were included. Demographics are summarized (table) by 3 disease severity groups at baseline: no supplemental oxygen (NSO), low flow oxygen≤ 6L/min (LFO), and high-flow oxygen > 6L/min (HFO). No demographic differences were found between groups except for the higher percentage of cancer/chemotherapy patients in NSO group. Corticosteroids use was HFO 73.6%, LFO 62.7%, NSO 58.0%. Mortality rate was significantly lower in NSO, and LFO groups compared with HFO (6.2%, 10.2%, 23.6%, respectively; Fig1). Median duration of hospitalization was 9 (95%CI 8-10), 9 (8-9), 13 (10-15) days, respectively (Fig2). Median time from first symptom to RDV start was 7 days in all 3 groups. Patients started RDV on day 1 of hospitalization in HFO and LFO and day 2 on NSO groups. And received a 5 day course (median). Readmission within 28-days of discharge was < 5% and similar across all 3 groups.Table 1: Patients baseline characteristics and primary and secondary outcomes
Figure 1: Kaplan-Meier estimates of mortality
Figure 2: Competing-risks regression of discharge from hospital

Conclusion: In this real-world cohort of COVID-19 positive hospitalized patients, RDV use was consistent across countries. RDV was started within a median of 7 days from symptom within 2 days of admission and given for a median of 5 days. Higher mortality rate and duration of hospitalization was seen in the HFO group and similar rates seen in the LFO and NSO groups. Readmission was consistently low across all 3 groups.

Presenting Author(s)

François Raffi, MD, PhD

Professor
Centre Hospitalier Universitaire de Nantes
NANTES, Pays de la Loire, France
Disclosure: Gilead Sciences (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member)Janssen (Consultant)MSD (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member)Roche (Consultant)Theratechnologies (Advisor or Review Panel member)ViiV (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member)

Co-Author(s)

NA

Nadir Arber, MD, MSc, MHA

Professor
Ichilov Medical Center
Tel Aviv, Tel Aviv, Israel
Disclosure: Check cap (Consultant)Coved cd 24 (Board Member)Israel Innovation Authority (Research Grant or Support)Nucleix (Advisor or Review Panel member)Zion Pharmaceuticals (Advisor or Review Panel member)
CR

Casper Rokx, MD PhD

Consultant
Erasmus University Medical Center
Rotterdam, Zuid-Holland, Netherlands
Disclosure: Gilead Sciences (Grant/Research Support, Advisor or Review Panel member, Research Grant or Support)Merck (Grant/Research Support, Research Grant or Support)ViiV (Grant/Research Support, Advisor or Review Panel member, Research Grant or Support)
LA

Lambert Assoumou, PhD

Sorbonne Université, INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP)
Paris, Ile-de-France, France
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
PS

Pallav L. Shah, MD, MBBS, FERS, FRCP

Consultant Physician & professor of Respiratory Medicine
Chelsea & Westminster Hospital, National Heart & lung Institute, Imperial College
London, England, United Kingdom
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
ND

Nathalie De Castro, MD

APHP Hôpital Saint-Louis
Paris, Ile-de-France, France
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AB

Ameet Bakhai, MBBS, MD, FRCP, FESC

Cardiologist / Research Director
Royal Free London NHS Foundation Trust
London, England, United Kingdom
Disclosure: Bayer AG (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Boehringer Ingelheim (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Bristol-Myers Squibb (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Daiichi-Sankyo Europe (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator)Janssen (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Johnson & Johnson (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)MSD (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Novartis (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Pfizer (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Roche (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)Sanofi (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau, Independent Contractor)
AS

Alex Soriano, MD

Infectious Disease
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Disclosure: Angelini (Speaker's Bureau)Gilead Sciences (Research Grant or Support, Speaker's Bureau)Menarini (Speaker's Bureau)MSD (Research Grant or Support, Speaker's Bureau)Pfizer (Research Grant or Support, Speaker's Bureau)Shionogi (Speaker's Bureau)
LM

Lourdes Mateu, MD, PhD

Germans Trias I Pujol Hospital
Barcelona, Catalonia, Spain
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CL

Carlos Lumbreras, MD, PhD

12 de Octubre University Hospital
Madrid, Madrid, Spain
Disclosure: Gilead Sciences (Grant/Research Support)MSD (Consultant)
VE

Vicente Estrada, MD, PhD

Hospital Clinico San Carlos
Madrid, Madrid, Spain
Disclosure: Gilead Sciences (Consultant, Grant/Research Support)Janssen (Advisor or Review Panel member)MSD (Consultant, Grant/Research Support)Theratechnologies (Consultant)ViiV (Consultant)
AC

Adrian Curran, MD, PhD

Hospital Universitari Vall d’Hebron
Barcelona, Catalonia, Spain
Disclosure: Gilead Sciences (Advisor or Review Panel member, Research Grant or Support)Janssen (Advisor or Review Panel member, Research Grant or Support)MSD (Advisor or Review Panel member, Research Grant or Support)ViiV (Advisor or Review Panel member, Research Grant or Support)
PS

Pierre-Olivier Sellier, MD, PhD

Saint-Louis/Lariboisiere Hospitals, AP-HP
Paris, Ile-de-France, France
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AD

Annie Duffy, MSc

Director
Research Organisation (KC) Ltd
London, England, United Kingdom
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CF

Carl Fletcher, MSc

Director
Research Organisation (KC) Ltd
London, England, United Kingdom
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Essy Mozaffari, PharmD, MPH, MBA

Senior Director
Gilead Sciences
Foster City, California, United States
Disclosure: Gilead Sciences (Employee, Shareholder)
RH

Richard Haubrich, MD

Vice President
Gilead Sciences
Foster City, California, United States
Disclosure: Gilead Sciences (Employee, Shareholder)
PH

Paul Hodgkins, PhD, MSc

Executive Director
Gilead Sciences
Foster City, California, United States
Disclosure: Gilead Sciences (Employee, Shareholder)
AP

Anton Pozniak, MD, FRCP

Consultant Physician
Chelsea and Westminster Hospital
London, England, United Kingdom
Disclosure: Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)Janssen (Grant/Research Support, Research Grant or Support)Merck (Advisor or Review Panel member)Theratec (Grant/Research Support, Advisor or Review Panel member, Research Grant or Support)ViiV (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)