A new clinical trial could significantly increase the rate of recovery and potentially save the lives of COVID-19 patients who have underlying health conditions.
Preliminary medical data shows people with pre-existing conditions, including diabetes, may experience serious complications from COVID-19, the novel coronavirus that’s infected and killed people worldwide.
Circularity Healthcare’s trial — which involves the use of an FDA-approved drug from Circularity in addition to IDE device D’OXYVA® (deoxyhemoglobin vasodilator), a non-toxic, non-invasive microcirculation transdermal device — is poised to help the most at-risk coronavirus patients experiencing complications due to diabetes, poor circulation, hypertension, cardiovascular disease, and high blood pressure.
Improved blood flow
This clinical trial represents the first biotech solution to improve a patient’s overall oxygen-rich blood flow.
D’OXYVA is a simple, commercially-available device that delivers transdermal carbon dioxide (CO₂) to the skin’s sweat pores and glands.
The device has already been shown to considerably heal diabetic wounds; improve blood pressure and general vital organ function of the kidneys, liver, pancreas, and brain; reduce the risks of amputations; and prevent sepsis and septic shock, all while improving the overall health for many at-risk patients.
“Anyone who suffers from an underlying condition should know that this treatment option is available,” says Norbert Kiss, CEO of Circularity Healthcare, LLC. “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.”
Helping COVID-19 patients
Researchers and clinicians are optimistic that this potential microcirculation and nerve stimulant therapy and treatment could help vulnerable coronavirus patients. Kiss says this device could benefit over 90 percent of COVID-19 patients.
Overseen by leading experts, D’OXYVA was evaluated over eight years and three dozen human studies where zero adverse effects were reported. The CO₂ is approved by the FDA for anesthesia as a non-toxic, simple molecule under the Medical Gas Safety Act of 2012. It’s in the final phase of getting a combination device-drug approval.
Research shows a significant decrease in both systolic blood pressure and diastolic blood pressure, throughout all study time periods, up to 240 minutes, which is the longest time period evaluated post-treatment.
Previous clinical studies show the healing, closure, and recovery of an otherwise non-healing ulcer due to diabetes and cardiovascular, is much faster with this method and is often successful when other treatment modalities have failed. It’s also been used as prevention against sepsis and septic shock.
D’OXYVA promotes central nervous system activity and microcirculation, the circulation of the blood in the smallest blood vessels. That microcirculation, especially at the organ capillary beds, is important since adequate blood flow in the capillary bed is necessary for tissue survival and ideal organ function.
If blood flow is impaired, passing too fast, or not at all, the tissue can’t extract the needed oxygen efficiently. That could result in chronic pain, poor wound healing, diabetic neuropathy and other conditions.
One major benefit to potential clinical trial participants is that D’OXYVA can be administered and monitored at home and patients would not have to be currently admitted to a hospital to participate. Each application lasts five minutes.
The clinical trials, which are waiting institutional review board (IRB) approval, will operate under existing contracts at multiple sites, including Harvard, Yale, M.I.T, USC, and UCLA, and others.
D’OXYVA, which is made at a factory in Fremont, California, is readily available, as is the pharmaceutical-grade CO₂ utilized by the device.
For more information on the trial: https://doxyva.com/covid-19/