Southern California Research Institute Receives FDA Greenlight for Ivermectin Clinical Trial

Southern California Research Institute Receives FDA Greenlight for Ivermectin Clinical Trial TrialsiteN

California’s ProgenaBiome recently received the greenlight from the U.S. Food and Drug Administration (FDA) for two Phase 2 clinical trials involving investigational therapies targeting COVID-19: one of them based on hydroxychloroquine and the other ivermectin. With approved investigational new drug (IND) applications, a dynamic and accomplished California gastroenterology principal investigator, Dr. Sabine Hazan, and team now prepare to conduct important studies investigating two possible economical therapies for treating SARS-CoV-2, the virus behind the COVID-19 pandemic.

In late JulyTrialSite reported that Dr. Sabine Hazan, a prominent Malibu-based physician and researcher, and her organization called ProgenaBiome, LLC would sponsor a Phase 2 clinical trial investigating the efficacy of ivermectin in combination with Doxycycline, much like the successful combination tested by Dr. Tarek Alam from the Bangladesh Medical College, in combination of with dietary supplements including Zinc, Vitamin D3 and Vitamin C. Dr. Hazan-Steinberg was also previously profiled by TrialSite as a dynamic, patient-committed and passionate health care advocate.

Then in August, TrialSite reported that Dr. Hazan-Steinberg joined forces with Dr. Thomas Borody from Australia to form Topelia Therapeutics, a new company created to commercialize cost-effective treatments against COVID-19, including one based on hydroxychloroquine and the other based on ivermectin. TrialSite reminded that often progress is actually made by those willing to “buck the trend,” potentially leading to the possibility of economical, safe and effective treatment approaches targeting the novel coronavirus.

FDA Agrees on Investigation

Now the FDA has just issued two “Study May Proceed” letters to the clinical investigator and trial site research organization. The Southern California-based research team will commence two Phase 2 clinical trials, including two controversial therapies involving combinations with Zinc, Vitamin D3 and Vitamin C, the antimalarial drug first embraced by much of the research establishment and ivermectin. 

The Phase 2 ivermectin study NCT04482686 involves the treatment of 300 COVID-19 patients with a combination of therapies or a placebo and standard of care. The study treatment duration is 10 days with follow up for 6 months. The study drug combination includes ivermectin, Doxycycline, and dietary supplements including Zinc, Vitamin D3 and Vitamin C.

Meanwhile, the hydroxychloroquine Phase 2 study NCT04459702 seeks to determine whether a dual or quadruple therapy (involving the antimalarial drug as well as Azithromycin and Ritonavir and Lopinavir) is more effective at treating COVID-19. The FDA approved study calls for 200 participants.

Recent Ivermectin Study Results

TrialSite has chronicled the extensive use of Ivermectin to combat COVID-19 and recently reported positive results from a clinical trial at Zagazig University in Egypt. Led by Dr. Waheed Shouman, the study results reveal that based on a study size of 304 (203 in ivermectin group), ivermectin is effective as a prophylactic against SARS-CoV-2, the virus behind COVID-19. Critics undoubtedly will point to study size and a few other elements of the study, but this is the third study to evidence effectivity of ivermectin in association with COVID-19.

About ProgenaBiome

ProgenaBiome, based in Ventura, California, is a genetic sequencing research laboratory dedicated to continuing the work of the late Dr. Sydney Feingold, a doctor who recognized the power of anaerobic bacteria and spent his life correlating microbes to diseases. This group is on a mission to crack the genetic code of a trillion bacteria, fungi and viruses that live in the human gut.

Led by Dr. Hazan, the group is dedicated to patient-centered, long-term health care. Dr. Hazan is joined by a committed team of medical professionals including her husband—prominent Malibu physician, Dr. Alon Steinberg. Now ProgenaBiome, the lab, CRO and now sponsor, runs 42 ongoing clinical trials investigating immunity and disease, including six COVID-19 studies validating, testing, prophylaxis and treatment protocols for the novel coronavirus.

Lead Research/Investigator

Sabine Hazan, MD