Your Coronavirus Update for July 13; stay up to date with Elite.
Nearly 13 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 571,000 deaths. Healthcare officials in the United States have reported more than 3.4 million positive COVID-19 patients and at least 138,000 deaths. Source: Johns Hopkins University & Medicine
More Data on Antiviral Remdesivir Released
Officials with Gilead Sciences Inc. have announced additional data on the company’s investigative drug remdesivir for the treatment of COVID-19. The data is being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference and includes a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – something officials are calling an important finding that requires confirmation in prospective clinical trials.
Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, reportedly found that traditionally marginalized racial or ethnic groups treated with remdesivir experienced similar clinical outcomes as the study’s overall patient population.
Gilead is also presenting new analyses of the company’s compassionate use program, which demonstrated that 83 percent of pediatric patients and 92 percent of pregnant and postpartum women with a broad spectrum of disease severity recovered by Day 28. To further the understanding of these results in individual patient cases, officials also recently announced the initiation of a global, open-label Phase 2/3 trial to evaluate the safety, tolerability, and pharmacokinetics of remdesivir in pediatric patients from birth to younger than 18 years of age. Gilead is also collaborating on a study for pregnant women, officials said.
Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of hospitalized patients with severe COVID-19.
“We are working to broaden our understanding of the full utility of remdesivir,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, in a prepared statement. “To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir. The data presented at the virtual COVID-19 conference will shed additional light on the use of remdesivir in specific patient populations, including those [who] may be susceptible to higher rates of COVID-19 infection, as well as others [who] are particularly vulnerable, including children and pregnant and postpartum women.”
The comparative pre-planned analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care treatment in the same time period as the SIMPLE-Severe study. Patients were primarily located in North America, Europe, and Asia. Findings from the comparative analysis showed that 74.4 percent of remdesivir-treated patients recovered by Day 14 versus 59 percent of patients receiving standard of care; recovery was defined as improvement in clinical status based on a 7-point ordinal scale. The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at Day 14 compared with 12.5 percent among patients not taking remdesivir.
The results of this comparative analysis add to the previously presented National Institute of Allergy and Infectious Disease (NIAID) randomized, double-blind, placebo-controlled study in hospitalized patients with COVID-19, which showed that remdesivir shortened time to recovery by an average of four days as compared to placebo. In the NIAID study, patients taking remdesivir trended toward lower mortality compared with those in the placebo group, but this result did not reach statistical significance.
The Phase 3 SIMPLE-Severe trial evaluated the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive either a 5-day or a 10-day treatment course of remdesivir in addition to standard of care. An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation; results from the expansion phase are pending.
WHO Initiates Independent Panel
Members of an Independent Panel for Pandemic Preparedness and Response will evaluate the global response to the COVID-19 pandemic through an initiative launched recently by the World Health Organization (WHO).
According to WHO officials, the panel will be co-chaired by Helen Clark, former prime minister of New Zealand, and Ellen Johnson Sirleaf, former president of Liberia. Operating independently, Clark and Sirleaf will reportedly choose other panel members and members of an independent secretariat to provide support.
According to Tedros Adhanom Ghebreyesus, PhD, MSc, Clark and Sirleaf were selected through a process of broad consultation with member states and world experts after member states adopted a resolution that called on WHO to initiate an independent and comprehensive evaluation of the lessons learned from the international health response to COVID-19.
“This is a time for self-reflection, to look at the world we live in and to find ways to strengthen our collaboration as we work together to save lives and bring this pandemic under control,” said Dr. Tedros in a prepared statement. “The magnitude of this pandemic, which has touched virtually everyone in the world, clearly deserves a commensurate evaluation.”
A special session of the WHO executive board is expected to be called in September to discuss the panel’s progress. In November, the panel will present an interim report at the resumption of the World Health Assembly, officials said. In January 2021, the WHO executive board will hold its regular session, where the panel’s work will be further discussed; and at the World Health Assembly in May 2021, the panel will present its substantive report.
EPA & CDC Collaborate on Disinfection Guidance
Officials with the United States Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) have jointly developed guidance that is intended to assist in properly cleaning and disinfecting public spaces, workplaces, businesses, schools, and homes.
The guidance includes a three-step process to develop a disinfection plan, implement a plan, and maintain and revise that plan as needed through a decision-making tool.1 The guidance also includes reminders about how the virus is spread to reduce exposure risk.1
Thank you for joining us for your coronavirus update for July 13. If you missed last week’s article, please consider reading it here.
1. Guidance for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools and Homes. EPA. 2020. Accessed online: www.epa.gov/coronavirus/guidance-cleaning-and-disinfecting-public-spaces-workplaces-businesses-schools-and-homes