Pasadena, Calif.-based Circularity Healthcare LLC has initiated a clinical trial to evaluate its transdermal microcirculation device in COVID-19 patients with underlying health conditions. The aim is to see if use of the noninvasive deoxyhemoglobin vasodilator (from which the product derives its name) improves outcomes in patients suffering from coronavirus-related complications due to diabetes, hypertension, cardiovascular disease or chronic obstructive pulmonary disease.

People with underlying health conditions are at higher risk for complications from COVID-19. In a recent study of 5,700 patients hospitalized with the novel coronavirus in New York City, 57% had high blood pressure, 42% were obese and 34% had diabetes. Among patients who died, those with diabetes were more likely to have received mechanical ventilation or ICU care. Patients with diabetes were also more likely to have developed acute kidney injury during their stay. The results were published online April 22, 2020, in The Journal of the American Medical Association.

Improves oxygen saturation

The combination product delivers pharmaceutical-grade carbon dioxide in a highly concentrated, super-saturated, gentle vapor anywhere on the skin or a wound, allowing the CO2 to pass through skin pores and absorb into the capillaries. Once inside the capillaries, the molecular CO2 acts as a gasotransmitter, triggering a series of reactions that improve central nervous system activity and microcirculation saturation – leading to increased oxygen saturation and tissue survival.

Circularity claims D’oxyva is the first biotech solution to improve overall oxygen-rich blood flow.

The trial is set to launch at multiple sites, pending IRB approvals, and will attempt to demonstrate significant improvements in underlying chronic disease states of patients with the novel coronavirus. Initial study sites include Harvard, Yale, the Massachusetts Institute of Technology, the University of Southern California and the University of California at Los Angeles.

The primary endpoint is full recovery plus improvement in such things as white and red blood cell production, angiogenesis, blood pressure and blood sugar levels, oxygen-rich blood circulation in major organs, waste removal, and tissue and cell regeneration.

Since the over-the-counter product can be safely monitored at home, patients do not need to be hospitalized to participate in the trial. The treatment takes just five minutes per application.

“We will be growing the subjects enrolled along with the sites involved, with an initial half dozen locations growing to over a dozen or more and hundreds of patients,” Norbert Kiss, Circularity’s CEO, told BioWorld. The study is expected to last three to four months.

Evidence-backed therapy

According to the company, more than three dozen human trials have shown D’oxyva’s to be effective in healing diabetic wounds, improving the function of vital organs such as the kidneys and liver, lowering blood pressure and preventing sepsis and amputations, with no adverse effects reported. Patients have experienced significant decreases in systolic and diastolic blood pressure, with consistent results through all study times up to 240 minutes, the maximum post-treatment time evaluated.

Circularity is currently expanding a phase III trial led by David Armstrong, of the Keck School of Medicine at the University of Southern California, which is intended to support FDA approval for D’oxyva in the treatment of diabetic foot ulcers.

“Every medical report released so far shows that severe COVID-19 patients need blood oxygenation and blood thinners,” Kiss said. “The overwhelming majority of patients have diabetes and cardiovascular issues beyond pulmonary complications, and they all have sepsis setting in early on. These are the exact main vitals and chronic diseases D’oxyva improves like no other medication currently available on the market.”

The pharma-grade CO2 is approved by the FDA under the Medical Gas Safety Act of 2012 as a nontoxic, simple molecule for use in anesthesia. The device is categorized by IRBs as a nonsignificant-risk device, with an investigational device exemption. Together, the products are in the final stages of obtaining approval as a combination drug and device product.

Kiss said all of the products for the trial are ready to launch. “CO2 is abundant to serve the population of the entire globe, and our company has warehouses and fulfillment centers around the world to serve any hospitals or individual in less than a week on average,” he said. The device is produced at the company’s factory in Fremont, Calif.