Top California Gastroenterology Investigator Leads Phase 2 Ivermectin Clinical Trial Targeting COVID-19 Cases

Jul 22, 2020 | Blog, COVID-19, Doxycycline, Dr. Sabine Hazan, Ivermectin, News, Popular Posts, Progenabiome LLC

Top California Gastroenterology Investigator Leads Phase 2 Ivermectin Clinical Trial Targeting COVID-19 Cases

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

The Sponsor

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.

The Study

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.

Principal Investigator

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 jordan@progenabiome.com. 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.

8 Comments

  1. Ram Bahadur

    When will publish data of ivermectine’s trials on covid19 patients?

    • TrialSite

      Dear Ram TrialSite will be discussing with the sponsor and will update when we have any material information.
      Regards,
      Publisher

  2. Walt

    This will all be mostly over in 2 years. This is why the current system for new drug and treatment approval needs to be rethought given the speed information travels today. We are still using 1900 methodology in 2020. This suits vested interests like the big pharmaceuticals fine as they can control the outcomes when they move at snail pace, but this does not work for the rest of us who need treatments ASAP in this situation. Having said that, I hope their studies are successful.

  3. DEBASHIS NATH

    I think at least two trials are completed. One of them is “SAINT” trial by Dr. Carlos Chaccour. I cannot recollect now the name of the other one. Do you have any information? Dr. Debashis Nath

    • Arun Kumar Laha

      COVID19 and Ivermectin

      High population density plus unlocking lead to community transmission, resulting in fast increase in the number of COVID19 cases in India. Good news is that, large number of infected persons would be cured of the disease without much symptoms; these asymptomatic persons would not subject themselves to any form of testing or treatment; they would roam freely in society and would infect more persons – and this would usher in HERD IMMUNITY in India.

      Patients with mild-to-moderate symptoms do not require costly indoor treatment; and such patients should be treated by doctors at the periphery; and the doctors should treat these patients based on clinical assessments of the patients – elaborate testing, to exclude COVID19, for each and every persons suffering from fever with mild-to-moderate Flu-like symptoms is a very costly proposition. There would be severe forms of chaos if we try to cater indoor treatment to all symptomatic patients presenting with mild-to-moderate Flu-like features. However, severely ill patients, aged patients with comorbidities should be admitted in well-equipped institutions.

      ICMR should allow doctors, not attached to any state-run hospital or private institution, to treat patients with mild-to-moderate Flu-like symptoms with a cocktail of drugs – Vitamin D, Vitamin C, Zinc, Azithromycin and Ivermectin. Doctors attached to state-run or private institutions are, I think, already instructed by ICMR about management of such patients at indoor and outdoor.

      COVID19 is a Global emergency; we do not have much time for elaborate clinical trials (multi-centric, double-blind, placebo-controlled, above all, reports should be acceptable to peer-group-reviewed international Journals) to prove or disprove efficacy of Ivermectin in treating COVID19. Doctors of many nations have published reports proving excellent efficacy of Ivermectin; no doubt, these studies have been conducted with a small number of patients; but still, we cannot discard the inferences of these reports out right, because these findings are collected by senior physicians with long experiences in clinical medicine.

      Arun Kumar Laha 09 06 2020

      IVERMECTIN

      Times Of India published two reports on 21st and 22th May praising Rendesivir and Favipiravir, two antivirals. Mainstream media worldwide are promoting these drugs of big pharma companies; however, most, if not all, antivirals are of questionable efficacy. No one is promoting IVERMECTIN, a cheap oral drug, prescribing which against COVID19 doctors from many nations, including Bangladesh, got EXCELLENT results. No one is interested in promoting this off patented molecule. Scientists could not fabricate vaccines against all and every pathogenic Virus; most probably, COVID19 is one of such type. Monoclonal antibody against viral proteins, however, is a good treatment plan.

      NO MASK, NO SOCIAL DISTANCING, NO LOCKDOWN, WILL BE ABLE TO SAVE HUMANITY FROM COVID19. IVERMECTIN, HCQ AND HERD IMMUNITY DUE TO SUBCLINICAL INFECTION IN COMMUNITY AT LARGE WOULD SAVE US.

      Fight against COVID19

      To fight against COVID19 India has to chalk out her own plan; we should not ape other nations. There would be serious socio-economic disaster in India if we continue total or partial lockdown. Most of the COVID19 infected patients in India are asymptomatic; and this might be due to the presence of Curcumin in our daily food. So, it is very difficult to determine patient- load in India; we can not test for COVID19 in all persons under the Sun.

      Asymptomatic persons would refuse testing and any form of treatment – they would roam freely in society; and would infect the population at large; and this will in near future usher in HERD IMMUNITY in India. Most of the symptomatic patients present with mild to moderate illness; we should treat them as OPD patients. We have to treat these patients with mild-to-moderate Flu-like symptoms as quickly as possible; so that they do not become severely ill to overwhelm the scarce indoor facilities in our country. Here is a safe outdoor treatment plan that will show quick and effective response in symptomatic patients (for adults): – Vitamin D & C and Zinc daily in usual recommended doses + Virostatic drug Ivermectin 12mg daily for 3 to 5 days + Senolytic antibiotic Azithromycin 250mg to 500mg daily for 5 days to 10 days. This treatment plan ushers in prompt response. Serious indoor patients would get these medicines + necessary supportive measures + Hydroxychloroquine (HCQS). – Arun Kumar Laha 29, Abinash Banerjee Lane. Howrah 711104. (laha.a53@gmail.com)

      Disclaimer: –

      This is not a prescription for the general public to self- medicate themselves. It is for the medical fraternity to think about my humble suggestion.

      To solve the problems of COVID 19, lockdown is not the only way out; we have to rely on development of HERD IMMUNITY by exposing people to low grade infection with COVID19 and we have to treat the symptomatic patients as fast as possible, to cut short the number of serious patients requiring indoor treatment.

      Many health- care personnel and other fighters against COVID19 are losing their lives to save humanity at large; ICMR should think about prescribing IVERMECTIN (12mg in empty stomach once in a week instead of Hydroxychloroquine) to these persons. Ivermectin is safer than Hydroxychloroquine.

      Clinical trials with IVERMECTIN

      To treat Covid19, Ivermectin should be given orally in empty stomach – 200mcg to 600mcg per Kg body weight daily for 3 to 5 days; and Azithromycin 250mg to 500mg orally in empty stomach for 10 days. This is the best treatment plan for Covid19 patients with mild-to-moderate symptoms. To prevent Covid19 one should take only Ivermectin in empty stomach 200mcg per Kg body weight once in a week. Clinical trials with inadequate doses of Ivermectin do not give desired results; and anti-Ivermectin lobbies would start shouting that, Ivermectin is worthless in treating and preventing Covid19.

    • TrialSite

      Yes we have shared results from Bangladesh and from University of Baghdad. Neither have made it into the major peer review journals.
      Thanks for visiting the TrialSite!
      Publisher

  4. Ram Bahadur

    What is the process for publishing results of any trials in medical journal?
    Why doesn’t publish result of completed trial of ivermectine’s in verious universities like bagdad and other’s yet?

    • TrialSite

      Dear Ram,
      We cannot be certain. There have been a few completed clinical trials including in Iraq and Bangladesh and several major observational undertakings–in some cases with many hundreds of patients to the case of the Grupo Rescue in the DR where we interviewed Dr. Redondo, president of that provider network, who has treated at least 1,300 patients–over 98%of them successfully according to the interview. Of course Dr. Rajter in Florida reported materially positive results as did Dr. Alam in Bangladesh. We are working on a major story in Peru as we speak.

      Thus far there hasn’t been any takers however from the major peer-review publications. Interestingly many send us comments and feedback that the pharma sector isn’t interested due to the economics. That could most certainly be the case as many companies, especially ones operating in expensive pockets in North America have enormous cost overhead and they must make calculated decisions where to invest. We understand this and although may not agree we know many great people in Pharma. They do care. They just work in a system.

      But what has been striking is the complete lack of intellectual curiosity from not only biopharma companies (which again at least have a micro-economic basis to focus on what keeps them afloat) but more importantly, health systems, community providers and frankly probably the mass of consumers is what is most surprising.

      Ram this suggests that a society is evolving (or devolving) in such a way that doesn’t encourage true critical thinking. Rather a herd like mentality sets in. And they must find justification in the big media (one of the handful of conglomerates that own the major outlets). But there are great people in these companies too and they have to bring in ad sales revenue.
      The Big media can’t focus on stories that turn off advertisers so they won’t focus on this.

      The TrialSite is independently financed so we can keep reporting on the facts and not what advertisers tell us to publish (or for that matter don’t tell us). If enough people form a critical mass to raise the question, force a dialogue and debate and shine more attention to some of these questions then believe it will be taken more seriously. That’s our dose of sobering night time medicine, or day time depending on where you are.
      Best Regards,
      Publisher

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