Virginia Commonwealth University (VCU), a prominent public research university in Richmond, Virginia, became one of the first clinical investigational sites in the world to begin clinical trials to study the safety and efficacy of the Novartis drug canakinumab on patients experiencing a type of severe immune overreaction called cytokine release syndrome. This occurs in some patients with pneumonia due to SARS-CoV-2, the virus behind the COVID-19 pandemic. It can often be deadly.
VCU Involvement in Fight Against COVID-19
This study, as reported by VCU News, joins other clinical trials at the university, including two remdesivir studies and another one using the rheumatoid arthritis drug sarilumab. VCH Health was one of the 180 clinical investigational sites that contributed to the recent clinical trial producing the positive outcomes evidencing remdesivir can positively impact COVID-19 patients. Speaking on the university’s commitment and dedication to the cause Peter Buckley, MD, dean of the VCU School of Medicine and interim senior vice president for VCU Health Sciences and CEO of VCU Health, noted, “As providers around the world seek to find the best course of treatment for COVID-19 patients, our researchers across VCU and VCU Health are doing the hard work of ensuring the safety and efficacy of potential future treatment options.” Recognizing the VCU team contribution to a worldwide effort, Dean Buckley quoted, “We are grateful to our teams for making investigational drug therapies a seamless part of our care and generating the data necessary to potentially make a variety of treatment options available to future COVID-19 patients nationally and globally.
The Drug: What is canakinumab?
Canakinumab is a human anti-IL-1β monoclonal antibody developed by Novartis. its mode of action is based on the neutralization of 1β signaling, resulting in suppression of inflammation in patients with disorders of autoimmune origin. In June 2009 the drug was approved by the US Food and Drug Administration for the treatment of familial cold auto-inflammatory syndrome and Muckle-wells syndrome, which are inflammatory diseases related to cryopyrin-associated periodic syndromes. See the list for FDA approvals. Reports from clinical trials suggest that canakinumab is well-tolerated in most patients, and no serious adverse effects have been reported. The drug provides significant advantages over existing competitive therapies, including bimonthly administration and approved use in children
This Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS). The study will enroll patients to canakinumab or placebo, in addition to standard of care (SOC) per local practice, which could include anti-viral treatment, corticosteroids and/or supportive care. The sponsor, Novartis and the research sites target 450 patients for this study that started April 30 and will end October 16, 2020.
Those patients that meet the inclusion criteria are randomized in a 1:1 ration to either the study drug (canakinumab) plus the SOC or placebo plus the SOC. They can be dosed immediately after ensuring that the they have met all eligibility criteria. Those patients that end up in the canakinumab arm will be dosed on Day 1 with canakinumab 450 mg for body weight of 40-<60kg, 600mg for 60-80 kg or 750 mg for >80kg in 250 mL of 5% dextrose infused IV over 2 hours. Patients in the placebo arm will be administered with 250 mL of 5% dextrose infused IV over 2 hours.
Virginia Commonwealth University Health
VCU Health involves the university’s health sciences schools, an academic medical center and a Level I trauma center. It is one of only two NCI-designated cancer centers in Virginia. Moreover, VCU Health, according to its website, includes the region’s only full-service children’s hospital.
VCU Health has over 800 physicians in 200 specialties and also maintains a community health center, dedicated research teams for clinical trials and contributes much and often to the community. Some recent metrics include nearly 800,000 outpatient clinic visits and 95,305 emergency department visits. They accomplish nearly 25,000 surgeries per year.
VCU Medical Center
This prominent hospital is VCU’s medical campus located in downtown Richmond, Virginia in the Court End neighborhood. Previously known as Medical College of Virginia, VCU Medical Center merged with Richmond Professional Institute in 1968 to crease Virginia Commonwealth University. For more VCU Medical Center details, see the link to its profile in the American Hospital Directory.
Antonio Abbate, MD, PhD, a cardiologist with VCU Health and the study’s Principal Investigator commented on Interleukin-1 β and the fact that it “…is an important cytokine that mediates fever and causes a cascade of inflammation in the body and is considered to be one of the key mediators in inflammatory response.
Benjamin Van Tassell, PharmD, professor in VCU’s School of Pharmacy and study co-investigator, reported, “Because of our familiarity with the drug and because we were intimately involved with VCU’s COVID-19 response, all the stars aligned and we were able to get this trial up and running really quickly.”
Importantly, both VCU Principal Investigators (Abbate and Van Tassel) were involved in a previous canakinumab clinical trial evidencing it reduced recurring cardiovascular events, independent of lipid lowering, reported VCU News. Undoubtedly, Novartis holds the two in some form of Key Opinion Leader status.
Antonio Abbate, MD, PhD, a cardiologist with VCU Health and the study’s Principal Investigator
Benjamin Van Tassell, PharmD, professor in VCU’s School of Pharmacy and study co-investigator
Call to Action: If you have a loved one hospitalized for severe COVID-19 symptoms, you may want to connect with this study team. TrialSite News can help you.