Stanford University moved quickly to ramp up the Gilead remdesivir global clinical trial—and enrolled 30 participants quickly thereafter for the adaptive clinical trial. And the elite San Francisco Bay Area academic medical center recently began enrolling patients in the National Institute of Health (NIH)-sponsored clinical trial centering on the safety and efficacy of remdesivir for COVID-19 patients. Shattering study startup records, Stanford launched these studies in record time: study startup typically takes two to three months at Stanford but the COVID-19 remdesivir studies were ramped up in literally weeks.
These aren’t Normal Times!
In normal times, a Phase III clinical trial often takes months of planning after years of research before such a study can commence, reports Tracie White with Stanford Medicine’s News Center. Of course, we live in very different times today. With a raging pandemic and a frantic race for treatments and vaccines, researchers (and the institutions that employ them) operate differently in this world. Consequently, the remdesivir studies have been ramped up in as little time as a week, reports the News Center. Hammering this point home, Aruna Subramanian, MD, clinical professor of infectious disease and coprincipal investigator of the Gilead trial at Stanford, reports, “We brought this on fast.” Dr. Subramanian continued, “We got everything together in a week and were ready to roll. This was record time. This type of thing normally takes two to three months to get on board.”
Remdesivir : A lot at Stake
Gilead and Stanford are neighbors—both situated in the San Francisco Bay Area’s Silicon Valley. As remdesivir has moved to the priority line based on current evidence, the pandemic rapidly expanded, and the hope is that the anti-viral therapy originally developed for Ebola, can slow down the impact of the viral infection. Recent evidence shows promise as TrialSite News reported the other day Gilead recently reported promising updates from its compassionate use program involving 53 COVID-19 patients. We have picked up anecdotal and sporadic data points as well that the drug can make a difference but until large random controlled trials are complete no declarations are responsible.
Stanford’s Stanley Deresinski, MD, associate chief of the division of infectious diseases, reports, “We have had patients hospitalized at Stanford who got remdesivir under compassionate care guidelines.” Dr. Deresinski continued, “Some got better, some got worse. At this point, we just don’t know. We hope to have results soon for remdesivir, and by then we should have another trial in the works for the next best thing.”
The company’s investigational drug is now being tested at about 100 research sites in the U.S. and abroad (including China). Moreover, Gilead expects to have preliminary data from a study of severe patients by the end of April. Two studies in China, reported Stanford’s Ms. White, were halted due to lack of patients.
Hopes High but also Read for Alternatives
Serving as Principal Investigator at Stanford for the NIH-sponsored remdesivir study is Neera Ahuja, MD. Collaborating with Kari Nadeau, MD, PhD, and others on the project, she notes that “We’re hopeful about remdesivir, but we are already planning for what the next drug might be.” She continued, “We want patients to get any possible treatments that might benefit them as soon as possible.”
Stanford Rational for Remdesivir
The school’s news reported that Cardinal researchers emphasize the drug’s results based on years of research with lab and animal research completed—not to mention clinical studies for Ebola. The drug actually failed to prove its efficacy for Ebola but did however prove it was safe in humans, reports Philip Grant, MD, assistant professor of infectious diseases at the School of Medicine and co-principal investigator the Gilead trial. Moreover, Robert Shafer, MD, professor of medicine at the School of Medicine, reports that for years remdesivir evidenced potential in cell cultures and animals infected by other coronaviruses, such as SARS and MERS. Note that Shafer’s lab recently developed a coronavirus anti-viral research database—similar to one they have accomplished for HIV.
Gilead-Sponsored remdesivir trial
Aruna Subramanian, MD, clinical professor of infectious disease and coprincipal investigator
NIH-Sponsored remdesivir trial
Neera Ahuja, MD, Clinical Professor, Medicine
Kari Nadeau, MD, PhD, Addisy Foundation Professor of Pediatric Food Allergy, Immunology and Asthma, Professor of Pediatrics, Senior Fellow at the Woods Institute for the Environment and Professor of Otolaryngology-Head & Neck Surgery