URMC to launch trials for possible coronavirus drug 

The University of Rochester Medical Center expects to launch clinical trials as early as this week on a drug that some specialists believe could alleviate symptoms associated with the novel coronavirus, according to the hospital.

As scientists around the world race to find treatments, URMC is on the precipice of conducting trials of the experimental drug remdesivir, which was developed to treat other viruses, including Middle East Respiratory Syndrome, known as MERS, and Severe Acute Respiratory Syndrome, or SARS.

The remdesivir trial will be led by Dr. Angela Branche, assistant professor in the university’s Division of Infectious Diseases, and medical professor Dr. Ann Falsey, an internationally recognized respiratory disease expert.

Branche said they were waiting for federal approval to begin the trial but that she expected to start “going live” early this week. She said the scope of the trial will be limited to COVID-19 patients who are hospitalized at Strong Memorial Hospital.

More than 50 hospitals around the country are participating, according to the National Institutes of Health.

The remdesivir trial is separate from another set of trials announced Sunday by Governor Andrew Cuomo, in which COVID-19 patients across New York may be given doses of hydroxychloriquine, zithromax, or chloroquine to relieve their symptoms.

Not everyone hospitalized at Strong with COVID-19 will receive remdesivir under the trial. The trial is a randomized, double-blind, placebo-controlled test, according to the NIH and URMC, meaning that some patients may receive a placebo rather than the drug.

Double-blind, placebo-controlled trials help researchers determine if a drug delivers better results than no medicine.

As of Monday, 11 people in Monroe County were hospitalized with COVID-19, according to the county. The county did not break down how many of the patients were at Strong.

In a news conference last week President Donald Trump touted the potential for remdesivir. He stated that the drug was “approved or very close to approved” by the Food and Drug Administration, although FDA Commissioner Stephen Hahn later clarified that remdesivir was “going through the normal process” of clinical trials.

Although remdisivir was not developed to treat COVID-19 specifically, Branche and other specialists believe it has the potential to relieve respiratory symptoms associated with the disease. Remdesivir does not attack a specific virus, but targets the way the virus replicates itself and spreads within an organism.

“I think the mechanism by which it works makes it a strong possibility,” she said.

Branche and Falsey are members of the Vaccine Treatment and Evaluation Unit (VTEU) network at the NIH, where they’re part of a group of researchers at hospitals trying to develop and test COVID-19 therapies and vaccines.

In December, the NIH awarded Branche and Falsey’s research group $4.3 million to study vaccines, treatments, and diagnostic tests for respiratory illnesses. At the VTEU’s first meeting in January, Branche said, Dr. Anthony Fauci, the NIH’s point-person for infectious diseases, told them they would be concentrating on COVID-19.

“It’s all I think about now,” Branche said.

Several hospitals around the country have announced their participation in remdesivir trials.

Remdesivir is an antiviral drug that has shown promise in test tube and animal studies on other coronaviruses such as MERS and SARS, but was disappointing in treating people with Ebola, according to a study published in December in the New England Journal of Medicine.

Also disappointing were the outcomes of another antiviral drug, Kaletra, an HIV treatment, that was recently tested on COVID-19 patients.

“There was hope that it would produce results because viruses often use similar enzymes to replicate, but it showed no efficacy compared to control,” said Dr. Tri Do, a professor at the University of California San Francisco.

Fauci has emphasized the importance of clinical trials in finding ways to address the pandemic.

“We urgently need a safe and effective treatment for COVID-19,” he said in a statement from the NIH. “Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes.”

Branche also pointed to the Kaletra trial as a reason to be cautious.

"That's why we do trials—to prove that there's a benefit or conversely that there's not, and to ensure that it's really safe to give to larger populations," she said.

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Annie Behr is a freelance writer for CITY.

Includes reporting from CITY News Editor Jeremy Moule. He can be reached at [email protected].

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