The University of Rochester Medical Center (URMC) plans the imminent launch of clinical trials on a drug some specialists purport could alleviate symptoms associated with COVID-19.  URMC reports its on the precipice of conducting clinical trials of the experimental drug remdesivir, which was developed to treat other viruses.  TrialSite News reported that at least in some locations it has been reported that remdesivir has had a positive impact on COVID-19 patients.

The study lead, Dr. Angela Branche assistant professor in the university’s Division of Infectious Diseases, teams with medical professor Dr. Ann Falsey, an internationally recognized disease expert. 

Awaiting Federal Approval

Dr. Branche reports that the team awaits federal approval to commence the trial however she anticipates starting soon—as early as this week in fact, reported Annie Behr with the Rochester City Newspaper.

Scope of the Clinical Trial

This clinical trial will focus only on COVID-19 patients who are hospitalized at Strong Memorial Hospital. However this study is one other sites TrialSite News has covered are participating in—sponsored by NIAID with the collaboration of Gilead: the makers of remdesivir. A randomized, double-blind, placebo-controlled trial, some Strong Memorial Hospital patients will receive remdesivir and others a placebo.

This study, however, is separate than another batch of studies announced by Governor Andrew Cuomo, in which COVID-19 patients across New York may be given dozes of either hydroxychloroquine, Zithromax or chloroquine to relive their symptoms.

Current Situation Monroe County

Ms. Behr reports that by Monday this week 11 people were hospitalized with COVID-19, although they didn’t breakdown which hospital the patients were at.

FDA needs to Clarify Presidential Statement

President Donald Trump nearly evangelized for the drug remdesivir which could be working in some cases. Trump declared the drug was “approved or very close to being approved by the Food and Drug Administration.” However, later on Stephen Hahn, an FDA commissioner reminded the public the drug was “going through the normal process” of clinical trials, reported Ms. Behr.

Stanford University Success Story

In fact, TrialSite News wrote of a Palo Alto, CA women fighting a severe case of COVID-19 that entered a clinical trial conducted at Stanford University. Just three days after taking the drug as part of the trial, her health started approving. We cannot be sure that her feeling was better was directly correlated to remdesivir, however.

The University of Rochester Medical Center Vaccine Treatment and Evaluation Unit

URMC’s Branche and Falsey are part of the Vaccine Treatment and Evaluation Unit (VTEU) network at the National Institutes of Health (NIH). This federally organized group has university members, part of a network working at hospital sites to develop and test COVID-19 treatments.

Both Branche and Falsey’s research group received $4.3 million late last year to study vaccines and treatments as well as diagnostic tests for respiratory ailments. In January, Dr. Anthony Fauci informed the VTEUs that they would focus on COVID-19.

The Infectious Diseases Research Clinic is located in the URMC. This clinic designs and conducts vaccine studies to prevent many different diseases that affect humans. The team in Rochester previously have worked on studies involving seasonal and avian flu, pneumococcal disease, anthrax, herpes, malaria, human papillomavirus (HPV) and smallpox. This clinic also operates an impatient facility at St. Mary’s Hospital in Rochester. The studies conducted at this inpatient facility focus on investigational vaccines and respiratory virus immunity.

Lead Research/Investigator

Dr. Angela Branche, MD

Dr. Ann Falsey, MD

Call to Action: Are you based in the Rochester, NY area and know of someone hospitalized at Strong Memorial Hospital with COVID-19? Consider contacting the study team.

Source: Rochester City Newspaper

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