Clinical Trial Explores Traditional Chinese Medicine Use Against COVID-19> News> USC Dornsife

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The pilot study focuses on a combination of 13 traditional medicinal compounds used in China at the start of the coronavirus epidemic. [5 min read]

Shortly after the appearance of the new coronavirus SARS-CoV-2 and the start of its spread in the Chinese city of Wuhan, the pandemic response team in China turned to traditional medicine to understand and treat the new disease. One therapy that has emerged is a new cocktail derived from ancient therapies.

The therapy has been widely used in Wuhan, and hospitals that have treated patients with it have seen significant success compared to those that have not. However, formal clinical trials designed to scientifically show whether the therapy is effective and to produce a detailed understanding of side effects were not conducted during the initial outbreak.

Today, researchers from USC Dornsife College of Letters, Arts and Sciences and Keck School of Medicine at USC have developed a plan to study traditional medicine used in Wuhan to counter the severe and often fatal symptoms that many COVID-19 patients experience.

The pilot study examines the use of Xuanfei Baidu granules (XFBD) for COVID-19 patients with mild to moderate symptoms.

A cocktail of traditional Chinese medicinal compounds

Doctor Zhang Boli, president of Tianjin University of Traditional Chinese Medicine, and his team, drawing on generations of knowledge, created XFBD using a combination of 13 distinct medicinal compounds targeting various symptoms of COVID-19.

The mixture includes compounds believed to reduce fever, clear the virus, suppress coughing, help clear phlegm from the lungs, soothe muscles in the trachea, and relieve shortness of breath.

Additionally, an ingredient is believed to provide a mild anticoagulant effect, potentially dissolving or preventing blood clots that can pose serious danger to COVID-19 patients.

The need for treatment options continues

Currently, there are few options for mild or moderate cases of COVID-19. Pharmacological treatments – such as antiviral and anti-inflammatory drugs – only become available slowly, initially focusing on severe cases and hospitalized patients.

While the number of cases in the United States has declined dramatically in recent weeks, the threat of a new wave still looms, especially at the current pace of vaccine distribution and as new, more contagious variants of the virus emerge. .

“We hope and should expect to move from the uncontrolled epidemic and the resulting need for mitigation to rapid containment of small outbreaks over the next 12 to 18 months. Continued vigilance, social distancing measures and vaccine distribution will be a key factor in this successful transition, but so will the availability of drugs that can reduce the risk of progression to serious illness, ”said Peter Kuhn, Professor of Biological Sciences to Dean and Professor of Biological Sciences, Medicine, Biomedical Engineering, Aerospace and Mechanical Engineering, and Urology at USC Dornsife.

Kuhn, founding member of the Bridge Institute of the USC Michelson Center for Convergent Biosciences, is the co-principal investigator of the study with his collaborator Darcy Spicer, associate professor of clinical medicine and head of the oncology division of the department of medicine at the Keck School of Medicine.

Building on years of collaborative science

Although no clinical studies examining XFBD have been undertaken, there is some evidence that traditional Chinese medicines can help. Before the widespread use of traditional medicines, China saw 10% of its mild and moderate cases progress in severity. As the use of traditional medicine has become more common, the number of escalating cases has decreased, with only 2-5% of them experiencing worsening of the disease.

Kuhn and Spicer, along with USC postdoctoral researcher Dornsife Elizabeth Qi, worked together to design a study that can scientifically determine what effect, if any, XFBD has on the progression of COVID-19.

Kuhn, who holds joint positions at the Keck School of Medicine and USC Viterbi Engineering School, previously studied the SARS virus responsible for the 2003 outbreak in Asia, said he had started discussing the current virus, SARS-CoV-2, and the disease it causes, COVID-19 , in early 2020 as the pandemic took hold in the United States.

“These conversations quickly focused on testing and therapy strategies,” Kuhn said. An exchange, with entrepreneur Ming Hsieh, president and CEO of Fulgent Genetics and administrator of USC, focused on what researchers in China had learned about the virus and the disease. This led to a formal collaboration between the USC team, Fulgent, and scientists at Tianjin University of Traditional Chinese Medicine, who developed XFBD.

“We are excited to partner with esteemed researchers at USC and leverage our next-generation sequencing capabilities to help develop this potential treatment for COVID-19,” Hsieh said. “We believe that by using our [next-generation sequencing] Our expertise as well as our knowledge of the evolution and treatment of COVID-19 in China, we have provided insightful and actionable data to the development of XFBD. “

Clinical trial paves way for better understanding of traditional medicine

The clinical trial is a pilot study conducted entirely remotely, including obtaining informed patient consent and monitoring patient performance. The resulting data produced will support the design of future XFBD studies.

During the 12-week study, patients are randomly assigned to one of two groups: one receiving XFBD and the other receiving placebo. Patients take the medication or placebo dissolved in water by mouth twice a day for 14 days, and the clinical trials team using remote patient management software will follow them 10 weeks later to assess their symptoms and their performance.

If the pilot study shows that XFBD is safe and that the remote trial is feasible, researchers can move on to phase II studies, which will involve a larger group of patients as well as specific subgroups of patients, such as specific age and ethnic groups. If these studies go well, phase III studies would follow to demonstrate clinical efficacy.

Ultimately, researchers hope to see if XFBD will reduce the risk of progression to serious illness, hospitalization, and death in people with COVID-19.

For more information on the study, see http://kuhn.usc.edu/xfbd.


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