Lifespan Researchers at Forefront of Remdesivir Study

Thursday, May 07, 2020

As the promise of remdesivir dominates news headlines, Lifespan researchers are investigating the experimental antiviral drug’s potential to shorten the course of COVID-19 illness in patients being treated at The Miriam and Rhode Island hospitals.

The Food and Drug Administration recently approved an emergency use authorization (EUA) for remdesivir to treat patients hospitalized with severe COVID-19. The federal agency defined severe disease as "patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator."

More than a hundred Lifespan patients have been enrolled in an international study sponsored by Gilead Sciences Inc., maker of remdesivir, said Karen Tashima, MD.

Dr. Tashima, director of clinical trials at the Immunology Center at The Miriam Hospital, is an attending physician, infectious disease specialist, and professor of medicine at The Warren Alpert Medical School of Brown University.

With 103 patients enrolled as of the end of April, The Miriam ranks fourth among 160 sites participating in the Gilead study worldwide, Dr. Tashima said. Globally, 2,500 patients have been enrolled toward a planned total of 6,000.

In a briefing at the White House last week, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced that a federal trial had shown that treatment with the experimental antiviral drug remdesivir could hasten recovery in patients infected with SARS-CoV-2.

While he acknowledged the study needs to be peer-reviewed, Dr. Fauci expressed hope that treatment with remdesivir could become the standard of care for patients who have COVID-19.

“I’m very happy that we are able to offer remdesivir to patients as part of clinical trials. Patients are contributing to the efforts to finding effective and safe treatments in this pandemic and we are grateful for their participation,” Dr. Tashima said.

Patients treated at The Miriam and Rhode Island hospitals have expressed their gratitude in follow-up interviews, with one woman telling Dr. Tashima, “I think this is really what helped me get better.”

Lifespan researchers had an advantage in becoming a study site because of their longstanding relationship with Gilead related to the HIV-AIDS and Hepatitis C work that has been ongoing at The Miriam for decades. “We were able to open up the study very quickly, and enrolled our first patient on March 20,” Dr. Tashima said.

That existing relationship and large number of patients enrolled in the study may be why Lifespan was also able to secure a rare supply of remdesivir to treat a limited number of patients outside the clinical trial. “We are among about only two dozen academic medical centers across the country so far to receive a limited supply of remdesivir to treat additional patients, under the emergency use authorization,” says Christine Collins, vice president and chief pharmacy officer for Lifespan.

Remdesivir originally was developed to fight Ebola but failed to produce positive results in a clinical trial in Africa. According to Gilead, preclinical data on remdesivir’s effect on MERS and SARS, coronaviruses that are structurally similar to SARS-CoV-2, indicate that the drug might have potential in treating COVID-19.

A study conducted in China, with results published April 29 in the British medical journal The Lancet, found no benefit to remdesivir vs. placebo in treating COVID-19, but that study’s validity is in question because of low patient enrollment.