Stanford Medicine Plays Key Role as Clinical Investigational Site in Two Critical Remdesivir COVID-19 Clinical Trials

May 3, 2020 | Coronavirus, COVID-19, Remdesivir, SARS-CoV-2, Stanford

Stanford Medicine Plays Key Role as Clinical Investigational Site in Two Critical Remdesivir COVID-19 Clinical Trials

Stanford Medicine was a key clinical investigational site for the remdesivir clinical trial—and as a result of these efforts, the FDA has authorized the first COVID-19 treatment. The two lead Stanford Principal Investigators are encouraged by the data indicating that remdesivir can treat SARS-CoV-2, the virus behind the COVID-19 pandemic.

Pandemic Updates

It has been one of the toughest periods in modern American history. As of this writing, with 3.5 million recorded SARS-CoV-2 cases worldwide, America has 1.17 million cases or about 33% of the world’s total. Of 247,312 deaths worldwide, 68,179 of them have occurred in the United States representing 27.5% of the world’s total deaths. For some perspective, America represents 4.5% of the world’s total population. The U.S. has been the central epicenter of this horrific pandemic. Within America low income, minority groups (African American males in higher numbers) and the elderly have been disproportionately impacted.

Stanford Participation in Two Critical Studies

Among the top five (5) medical schools in the United States, Stanford Medicine was a key research site in the remdesivir clinical trials during this pandemic. As reported by Tracie White with Stanford, the university commenced patient recruitment for the two studies in early March as ill patients showed up in the hospital. TrialSite News reported on one of those patients who started to feel better as the treatment continued. The two trials included many research sites around the nation in addition to Stanford. One of the studies was a randomized, placebo-controlled trial sponsored by the National Institutes of Health while Gilead sponsored the other study that lacked a placebo arm. Gilead, the drug’s maker, is located nearby Stanford in Foster City, CA.

Trials Lead to FDA EUA

These clinical trials produced the data that allowed the U.S. Food and Drug Administration (FDA) make the call to accept the data has overall promising and by May 1, just two days after the release of the early data, the U.S. Food and Drug Administration approved emergency use of the drug for the treatment against COVID-19.

Results

Stanford Medicine News reported that Gilead announced that a five-day treatment course with the drug (Remdesivir) was potentially as effective as 10-days of treatment in its trial of severely ill patients. The NIH shortly after reported that the drug helps to accelerate the time to recovery in severely ill patients: the NIH did change the evaluation criteria two weeks prior to the conclusion. The recovery time for severely ill patients declined from 15 days to 11 days. The ultimate data was derived from the studies involving a total of 1,063 patients from 68 sites (47 in the U.S. and 21 in nations in Europe and Asia). The final results are still going through peer review.

Dr. Anthony Fauci reported that the “Data shows it has a clear-cut positive effect in diminishing the time to recovery.” He continued “What this drug has proven is that a drug can block this virus.”

Principal Investigators Comment: Excitement but Pragmatism

Neera Ahuja, MD, principal investigator of the NIH-sponsored trial and chief of the division of hospital medicine, reported, “I’m very excited by the trial results.” She did acknowledge that the study results aren’t “…a panacea. We don’t know if this is the best treatment. It’s an IV drug at this time and can’t be given outside the hospital. We will need to look for the most effective drug.”

Aruna Subramanian, MD, and the principal investigator of the Gilead trial at Stanford, reported that “To at least have something that we can potentially use as a treatment for this virus is very assuring” On the fear and uncertainty, especially during the beginning of the pandemic, “In the early course of the pandemic, we were so scared and disheartened by patients going downhill and needing to be on a ventilator for so long. To see that even those people can potentially be turned around is very encouraging.”

Lead Research/Investigator

Neera Ahuja, MD principal investigator, Clinical Professor, Medicine

Aruna Subramanian, MD and the principal investigator, Clinical Professor, Medicine, Infectious Disease

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