Promising Treatments for Covid-19 Enter Clinical Trials

While vaccines have rapidly gone from clinical trials to arms at what seems like a rapid speed, treatments for COVID-19 have fared a lot slower. But research continues with many advances now in human clinical trial testing. Presently, COVID-19 is now being treated with standard therapies, including steroids, antivirals and monoclonal antibodies. During this first year of the pandemic, approximately 840,000 patients required hospitalization in the US.

Researchers at two major medical centers in Israel, Rambam Medical Health Care Campus and Ziv Medical Center, have initiated a Phase 2 clinical trial of a promising new treatment for COVID-19. These trials are testing TXA27, a compound that prevents cell proliferation and inflammation in the lungs per Professor Karl Skorecki, Dean of the Azrieli Faculty of Medicine of Bar-Ilan University in the Galilee.

Coronavirus enters the human body by binding to Angiotensin-Converting Enzyme 2 (ACE2) receptors, which are also responsible for producing Angiotensin (1-7). This interaction leads to a reduction in Angiotensin-(1-7) and the loss of its intrinsic protective effects.

“When the enzyme is busy acting as a receptor for the virus, it can no longer do what it is supposed to do, which is make Angiotensin (1-7),” Professor Skorecki said. “We hope that by replenishing this peptide, the lungs of patients will get back what the virus nefariously took away from them.”

Research has shown that respiratory failure is the leading cause of death in COVID-19, and inflammation in the lungs may lead to secondary damage of other tissues through the release of cytokines. SARS-CoV-2 directly affects the endothelial lining of blood vessels leading to hypercoagulation and stroke. In multiple animal models of acute lung injury, Angiotensin-(1-7) reduces these effects and may improve many of the symptoms associated with COVID-19, both in the acute form and in “long-COVID”.

Older drug sees new purpose.

Meanwhile, FSD Pharma headquartered in Toronto has begun clinical studies using a drug called ultramicronized palmitoylethanolamid (or micro PEA).

Micro PEA is a unique drug. It is believed to act as an anti-inflammatory and promoted between 1969 and 1979 in former Czechoslovakia as treatment for influenza and the common cold. Clinical trials conducted at the time showed PEA was an effective prophylactic in respiratory infection, with no registered side effects. According to scientists behind the research, it could act as a quick therapeutic answer for the ongoing COVID pandemic.

Today, the drug is promoted as a prescription nutraceutical in Italy and used to treat chronic inflammation.

“We contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines,” Philadelphia-based physician and FSD CEO Dr. Raza Bokhari.

Dr. Raza Bokhari, FSD Pharma’s CEO emphasized that FSD does not claim cannabinoids, synthetic or plant-based, is an alternative for COVID-19 treatment. But the CEO said FSD-201 modulates the endocannabinoid system as “a naturally occurring fatty acid” by targeting CB2 receptors, which are believed to affect pain and inflammation in humans.

“Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm,” said Bokhari in a statement to the press.  “FSD-201 is not a virus killer. But we believe it can mitigate that immune response, which can be fatal.”

Treatment for COVID-19 outside the hospital setting.

University Hospitals announced Monday that they will participate in a clinical trial of a drug to treat people with COVID-19 who do not need to be hospitalized.

UH will be one of the first sites in the nation for the phase 2 clinical trial of the orally-administered drug known as Upamostat, according to a hospital press release.

The drug has demonstrated antiviral and potential tissue-protective effects, the release said. RedHill Biopharma is evaluating the drug’s effectiveness in treating people who have COVID-19 and are experiencing symptoms of the infection but do not need to be in the hospital.

“Laboratory studies have shown that Upamostat may prevent attachment and entry of SARS-CoV-2 virus, commonly called COVID-19, particles to cells. Therefore, it is being studied to see if it helps people with coronavirus infections at an early stage before they become severe and require hospitalization,” said Grace McComsey, the Vice President of Research at UH who is leading the study. “This is what we need currently; we need early COVID-19 studies to keep people at home and out of the hospital and keep COVID-19 as a mild illness that does not progress.”

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