A dynamic research organization in Ventura, California, called Progenabiome, LLC will initiate 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 Bangladesh Medical College, in combination with dietary supplements including Zinc, Vitamin D3 and Vitamin C. The study is led by a top principal investigator in California, profiled previously by TrialSite: Dr. Sabine Hazan.
A genetic sequencing research laboratory, Progenabiome dedicates their efforts to the work of the late Dr. Sydney Finegold, a pioneer in the field of anaerobic bacteria research. Their research is driven by a passion and mission that cures to diseases can be identified by investigations into the gut flora influenced by the work on Fecal Microbiota Transplant of Dr. Thomas Borody.
They are involved with a range of research activity from assay development and clinical trials to companion diagnostics and “Gut Refloralization” to the development of COVID-19 treatment protocols.
Based in Ventura, California, their true mission is to crack the genetic code of a trillion bacteria, fungi that lives in the human gut. Their hopes: find cures to diseases that they suspect may be caused by alteration of the gut flora.
Officially titled “A Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection,” the study start date is planned for August and their protocol calls for a two year ongoing study, but assuming they can enroll and treat sufficient numbers of participants, they will be able to report on results earlier. They are seeking to enroll 300 participants with either intervention or placebo arm of the study.
The intervention arm incudes ivermectin (Soolantra, Stromectol, Sklice) as well as the antibiotic Doxycycline, Zinc, Vitamin D3 and Vitamin C.
The sponsor has established four (4) primary outcome measures, including 1) time to negative RT-PRC result indicating the patient is no longer infected; 2) time to reduce symptom progression in days as measured by NEWS scoring system (National Early Warning Score); 3) Time to Symptom improvement as measured by NEWS scoring system and 4) Efficacy of treatment as measured by TITER. They have established several secondary outcome measure targets a well.
The study will be led by Dr. Sabine Hazan, MD. Dr. Hazan is a specialist in gastroenterology, internal medicine, and hepatology. She has been profiled by TrialSite as she is also the Founder and CEO of the Malibu Specialty Center and Venture Clinical Trials, where she conducts and oversees clinical trials for cutting-edge research on various medical issues. Dr. Hazan is a top principal investigator for multiple global pharmaceutical companies and also serves as an editor of Practical Gastroenterology on the microbiome, a peer review journal that reaches 18,000 gastroenterologists. She has been a speaker at the World Congress of Digestive Disease, MAGI, Microbiome Congress, International Drug Discovery Science and Technology Conference, and NIST.
Call to Action: If you reside in the Ventura area and meet the inclusion criteria, consider contacting the center when this study commences. The contact there is Jordan Daniels, MS, at 805-339-0549 or email [email protected]. Interested in Ivermectin and COVID-19 research? Feel free to contact TrialSite, which has accumulated perhaps more information than any other group on the planet.