We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App





Gilead’s Phase 3 Trial of Remdesivir Demonstrates Significantly Greater Clinical Improvement in Patients with Moderate COVID-19

By LabMedica International staff writers
Posted on 02 Jun 2020
Gilead Sciences, Inc. More...
(Foster City, CA, USA) has announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia.

Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. Outside of Japan, remdesivir is an investigational, unapproved drug. The US Food and Drug Administration (FDA) has granted temporary Emergency Use Authorization to remdesivir for the treatment of hospitalized patients with severe COVID-19.

In the latest study, hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for 5 or 10 days or standard of care alone. The primary endpoint was the clinical status as assessed by a 7-point ordinal score at Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.

At Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard of care group, achieving statistical significance for a ≥ 1-point improvement in ordinal scale (p=0.026). In addition, non-statistically significant increases in clinical worsening or death were observed in the standard of care only group compared with the remdesivir groups.

“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”

“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results. The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes. Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations.”

Related Links:
Gilead Sciences, Inc.


Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Drug Test Kit
DrugCheck 3000
New
Automatic Hematology Analyzer
LABAS F9000
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Molecular Diagnostics

view channel
Image: The RNA-seq based diagnostic test for pediatric leukemia ensures better outcomes for children with this common cancer (Photo courtesy of Qlucore)

RNA-Seq Based Diagnostic Test Enhances Diagnostic Accuracy of Pediatric Leukemia

A new unique test is set to reshape the way Acute Lymphoblastic Leukemia (BCP-ALL) samples can be analyzed. Qlucore (Lund, Sweden) has launched the first CE-marked RNA-seq based diagnostic test for pediatric... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.