The novel coronavirus has changed nearly every aspect of our lives. As of Sept. 23, there were over 31 million global cases and nearly 7 million in the United States. During the week of Sept. 20, we also saw the number of deaths in the United States surpass the grim benchmark of 200,000.
It has been eight months since the first reported case of a Washington traveler. The U.S. leads the world in coronavirus deaths and has the most reported cases.
Research for potential vaccines, treatments and improved testing have rapidly increased. Gilead Sciences ramped up production of its remdesivir treatment months ago, and now Rosedale Health and Wellness in Huntersville, N.C. is part of a new outpatient study.
According to an open letter from Gilead Chief Executive Officer Daniel O’Day, it is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19. Based in California, the pharmaceutical company has been at the center of HIV antiretrovirals and well-known HIV pre-exposure prophylaxis (or PrEP) medications Truvada and Descovy.
Currently, there are no antiviral medicines to treat COVID-19 and no licensed vaccines to prevent infection.
Like other treatments currently being tested, the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to remdesivir for the treatment of patients with COVID-19. The drug is currently listed in 59 separate studies around the globe with 30 currently recruiting. Only nine of those are active in North Carolina.
“During this pandemic, I am glad we can offer treatment options to our community and at the same time have a broader impact in the world during the pandemic,” said Dr. Frederick Cruickshank in a recent statement by Rosedale. Dr. Cruickshank is an infectious disease specialist who started Rosedale as a private practice in 2006. Rosedale will partner with Gilead Pharmaceutical on the treatment trial through December. It is one of 100 worldwide sites for the medical trial to treat patients with mild to moderate symptoms of COVID-19.
It includes a three-day intravenous (IV) treatment with one month of follow-up, according to Rosedale’s Director of Clinical Research Steven Haynes. There is no cost to patients, and participants in the study will receive a small stipend. Earlier studies have been focused on hospitalized settings and severe cases. “If we can take this into the outpatient clinic, and we can catch those patients before they get to that moderate/severe stage, we can keep them from getting into the hospital system,” says Haynes.
According to ClinicalTrials.gov, a database of the U.S. National Library of Medicine, the trial’s primary objective is to evaluate the efficacy of remdesivir in reducing the rate of hospitalization or death in non-hospitalized participants with early stage COVID-19.
This reduces the burden on hospitals. The study will also evaluate the safety of administering the drug in an outpatient setting. Five other locations in the U.S. (three in Florida, one in Maryland, and one in Mississippi) are taking part in the Gilead-funded trial. “We continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the course of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies,” said O’Day in an earlier statement.
Participants must be over the age of 18 and have at least one pre-existing condition unless they are over the age of 60 years old, which automatically qualifies them. The treatment needs to start four days after receiving a positive result, so only recently diagnosed people with one or more symptom can take part in the study. Testing can be done at Rosedale for current or new patients or at other certified testing centers.
“With this study and potential for care we can get our patients treated and know they are being taken care of, as opposed to sending them home and letting them fight this on their own,” says Haynes.
There is still limited knowledge about COVID-19 and its long-term effects. Haynes points out that the study will hopefully make the disease a little more manageable and less dangerous for people. Earlier trials have shown that remdesivir shortened time to recovery by an average of four days.
After an initial screening following that positive result, there is a multi-day treatment regimen. According to Haynes, the “Day 1 visit” is where they start the IV treatment, which takes between 30 and 45 minutes. Patients will see providers and have labs done for three consecutive days. Return visits occur on Day 7, Day 14 and Day 28, where they formally complete the study.
Haynes points to the limited intrusion that this study causes but understands that some people are still skeptical about any medical research. “I will not conduct any research study here that I would not put myself or a family member in,” he says.
Rosedale is known for research projects working with HIV patients. It currently has active studies on Dovato, Biktarvy, a six-month injection trial with Gilead, and a two-month injection by ViiV Healthcare. In addition to the research department, the clinic offers primary and specialty care, an on-site Walgreens pharmacy, nutritionist, mental health support and Dudley’s Place, a non-profit focused on HIV care and prevention.
Haynes has wanted to venture into other areas of internal medicine and sees this as a step for the organization to that next level as a medical research facility.
To participate in the study, interested parties can contact Rosedale at 704-659-7799, or email Haynes directly at email@example.com.
qnotes is part of six major media companies and other local institutions reporting on and engaging the community around the problems and solutions as they relate to the COVID-19 pandemic. It is a project of the Charlotte Journalism Collaborative, which is supported by the Local Media Project, an initiative launched by the Solutions Journalism Network with support from the Knight Foundation to strengthen and reinvigorate local media ecosystems. See all of our reporting at charlottejournalism.org.