Covinnovations™ Announces Plans for FDA EUA for CovArrest™
Covinnovations™ announced Friday that it has begun the process for FDA Emergency Use Authorization (EUA) for its CovArrest™ COVID-19 treatment. CovArrest™ is a patent-pending, trademarked drug combination, created by founder and inventor, Dr. Aury Nagy. It halts the cytokine storm that COVID-19 creates. “It is the cytokine storm that, in turn, kills so many people,” Covinnovations™ said in a statement.
CovArrest™ is administered to hospitalized patients who have moderate to severe COVID-19 symptoms and require oxygen. “Once a patient has reached the point of requiring oxygen supplementation, the cytokine storm becomes very dangerous and can quickly lead to intubation,” said Kristine Leavitt, Vice President-Clinical Trials.
Covinnovations™ has two other unique new tests; CovAssess™ and CovaTest™. CovAssess™ is a dual-marker COVID-19 susceptibility test that can measure a person’s chances of catching the Coronavirus and even dying from it. CovaTest™ is an RNA-based rapid test being designed for home use or point of care that can determine the presence of COVID-19 and the strain in about 2 minutes. Both tests are in the pre-prototype phase of development.
“We believe these tests and CovArrest™ will save lives,” said Covinnovations™ in a statement. Currently, there is only one therapeutic approved by the FDA for COVID-19 standard of caretreatment. Covinnovations™ believes they have the next one in CovArrest™. CovArrest™ is a combination of already FDA approved drugs used to treat other indications, that when combined in a certain formula and are administered over the course of a treatment, demonstrates remarkable recovery rates for hypoxic COVID-19 patients.
“These are the sickest of the sick,” said Leavitt. “These are the people who end up in ICUs intubated on ventilators. And, unfortunately, these are our loved ones that Coronavirus ends up killing.” Covinnovations™ has hired an FDA specialist to assist with the FDA fast-track process for EUA. “We believe that we have an answer for these people. With or without a vaccine, we believe CovArrest™ gives hope to those who catch COVID-19 and become very sick,” said Leavitt.
There is no timetable for FDA fast track, however, Covinnovations™ believes that they have a compelling case for a speedy EUA approval and are committed to seeing the process through to fruition.
About CovArrest™
This new drug is composed of two current FDA-approved drugs that work synergistically to attack the same disease and are both metabolized by the same liver enzymes. One of the components of CovArrest™ showed significant success in a retrospective review completed in December 2020. This study demonstrated a 68% reduction in mortality (p<0.05) and a 37% reduction in length of hospital stay (p<0.01). The treated group and the control group both received standard of care treatment as of 6/2020. Patients in the group provided the drug had a 93.6% survival rate as compared to the control group which had a survival rate of 78.5%. Those who did not survive appeared to experience a resurgence of viral replication or an insufficiently suppressed immune response, leading to the addition of the second component of CovArrest™. A subsequent cohort of 11 patients with the combined drug achieved 100% survival.
ABOUT Covinnovations™
Covinnovations™ creates technologies and solutions directly related to the COVID-19 pandemic. The company’s patent-pending treatments seek to create a new standard of care in the battle against this disease. Covinnovations™ products feature groundbreaking technologies that assess, diagnose and treat COVID-19 with the goal of integrating our world back to pre-pandemic times. The company was founded by Dr. Aury Nagy, M.D. FAANS, a neurosurgeon practicing in Las Vegas.
For further information, visit: www.covinnovations.com.
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