New COVID-19 Clinical Trial Announced To Treat Patients With Underlying Medical Conditions

A Pasadena-based biotech company has started a clinical trial using a drug they say could significantly increase the rate of recovery for COVID-19 patients with underlying health conditions.

The company, Circularity Healthcare, said its trial will help some of the most at-risk patients suffering from complications due to diabetes, poor circulation, hypertension, cardiovascular disease and high blood pressure.

The trial will involve the use of Circularity’s already FDA-approved drug and IDE (investigational device exemption) device called D’OXYVA, short for “deoxyhemoglobin vasodilator,” which the company describes as a “non-toxic, non-invasive microcirculation transdermal device.”

In a statement, Circularity Healthcare said D’OXYVA is the first biotech solution of its kind to improve overall oxygen-rich blood flow.

The statement said the device has been shown to significantly heal diabetic wounds, reduce the risks of amputations, prevent sepsis and septic shock,  improve blood pressure and general vital organ function of the pancreas, liver, brain and kidneys, while increasing overall health for some of the most vulnerable patients.

“Anyone who suffers from an underlying condition should know that this proven treatment option is available,” Norbert Kiss, Circularity Healthcare CEO, said. “Every medical report released so far shows that severe COVID-19 patients need blood oxygenation and blood thinners. 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 company said D’OXYVA has gone through eight years of three dozen human studies at some of the most prestigious universities and hospitals in the world, including Penn State and Airlangga University, and no adverse effects were reported.

Now expanding its Phase 3 trial, the device, manufactured in the company’s factory in Fremont, California, uses pharmaceutical-grade CO2 which has been approved by the FDA, the company said.

The company said the use of transdermal CO2 therapy has shown great success to improve the healthcare of patients with high blood pressure, general vital organ function of patients with high blood pressure, and general vital organ function like that of the pancreas, liver, brain, and kidneys.

The clinical trials are now waiting for approvals by institutional review boards and are about to launch under existing contracts at multiple sites, including top U.S. universities such as Harvard, Yale, M.I.T, USC, and UCLA, according to the statement.

The statement said potential patients do not have to be currently admitted to a hospital in order to take part in the trial.

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