WHO & Pan American Health Organization Position on Ivermectin Use & COVID-19: Produce Evidence via RCT

Jun 25, 2020 | COVID-19, Ivermectin, News, Pan American Health Organization, World Health Organization

WHO & Pan American Health Organization Position on Ivermectin Use & COVID-19 Produce Evidence via RCT

Recently, the Pan American Health Organization (PAHO) and the WHO (World Health Organization) came together to respond to the growing use of Ivermectin around the world (especially in South America) to treat COVID-19. Although the “Monash” study demonstrated successfully that ivermectin could be used to treat SARS-CoV-2 in experimentally infected cells and two preprint publications, based on observational studies reporting the apparent utility of ivermectin to treat patients with COVID-19 needing mechanical ventilation, none of these sources represent sufficient evidence justifying use of the drug off label. The observational studies were not accepted in any peer reviewed journals and one of them was associated with the suspect “Surgisphere” group. Consequently, PAHO and WHO recommend the only ivermectin use occur in randomized controlled trials. TrialSite News would only add that there are a growing number of well-respected physicians around the world that have set up careful ivermectin off label case studies with successful results according to their reports and associated interviews. Moreover at least 30 clinical trials involving ivermectin have commenced and in fact two are now completed. Could there be an institutional bias against ivermectin?

PAHO and WHO position that any ivermectin use in relation to COVID-19 that is not part of a randomized controlled trial (RCT) represents an incorrect use of the drug. That is because there is not any formal scientific evidence of its efficacy and safety for the treatment of the disease. However, WHO and PAHO in fact dictate that any use of unproven therapies, such as ivermectin, must be undertaken in the context of a RCT. In the recent joint report, WHO shares a link to its position on off-label use of treatments for COVID-19.  

It is important to note that the U.S. Food and Drug Administration (FDA) has a similar message and although they have modified their “FAQ: COVID-19 and Ivermectin Intended for Animals,” they still concede “data from clinical trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-19.” What the FDA is really stating is that they are not precluding the use of ivermectin in randomized controlled trials but actually embrace the opportunity to review data from such trials. However, there are only a couple trials at this point in the United States.

Ivermectin RCT Status

At present, at least 30 clinical trials involving ivermectin are disclosed in the Clincaltrials.gov government database. This figure could in fact be higher as there could be additional studies around the world that are not included in this database. A couple of the studies are completed, and in fact, principal investigator Faiq Gorial of University of Baghdad, Iraq communicated with TrialSite News that they were in fact trying to get their results published. Dr. Gorial did not disclose any findings to TrialSite News so it isn’t clear what the outcomes in fact were. This study, funded by the university, was to compare the efficacy of add on therapy of single dose 12mg ivermectin to hydroxychloroquine (HCQ) and azithromycin (AZT) in COVID-19 patients to non-ivermectin group (HCQ+AZT). The established primary outcome measure centered on a 4 week time span and the number of patients cured by Nasopharyngeal swab, oropharyngeal swab and blood aspiration for COVID-19 (PCR) plus a chest X-ray. Obviously, HCQ fell way out of favor in many nations so this entire study will be questioned by powerful interests.

Another purportedly completed study out of Bangladesh involves the ivermectin/Doxycycline treatment administered by Dr. Alam in is now well known off-label Bangladesh Medical College protocol approved case effort and Hydroxychloroquine and Azithromycin.

Sponsored by Upazila Health & Family Planning Officer’s (UHFPO) Office, Chakoria, Cox’s Bazar, this observational study was conducted from May 2 to June 5th, 2020. The investigators observed 181 patients who tested positive for COVID-19 via RT PCR.  The testing was completed at Cox’s Bazar Medical College. Patients were carefully evaluated for comorbidities, etc. and treated as an outpatient protocol.

The patients were divided into two groups, including Group A (n=60): Ivermectin 200 µgm/kg single dose + Doxycycline 100mg BID for 10days and Group B (n=56): Hydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin 500mg daily for 5Days. The results of this study have not been published anywhere accessible as of yet.

Ongoing Studies

A number of prominent studies involving ivermectin are now planned or underway from Sheba Medical Center (Israel) to Johns Hopkins University and University of Kentucky to a major hospital chain in India called Maxx Healthcare backed by American private equity group KKR. Ivermectin randomized controlled trials are occurring from Mexico and Argentina to Pakistan and Singapore. By mid to late summer, the hope is that sufficient data will start educating the world as to the evidence of this approach to treating COVID-19.

Conclusion

Although TrialSite News has interviewed physicians that have conducted what they declare are successful off-label studies with Ivermectin, from Dr. Alam at the Bangladesh Medical College to Dr. Rajter at Broward Health in Florida to physicians in Columbia and Peru, until the evidence is generated from the 30 or so randomized controlled trials ongoing, there will be little attention paid to this economical and widely accessible investigational approach to treating COVID-19. And in America, the U.S. based studies would have to produce some compelling evidence to peek the FDA’s interest. In other parts of the world, the various health authorities and medical establishments should become more intrigued should these studies produce materially significant results. In the meantime, the pandemic actually worsens. The U.S. had its worst day on record on Wednesday June 25.

8 Comments

  1. Walt

    It is interesting that some of these studies are having difficulty getting published.. Unfortunately it is looking more and more like entrenched interests are raising their ugly heads. Four words big pharma does not want to hear, effective, inexpensive, available and safe. They cannot make any profit from this human tragedy if a therapeutic like that is found. TrialSite, take the lead, make these studies available for the good of everyone. Dr. Gorial should be putting his research out there on the pre peer review sites, if none of the so called respectable scientific journals will publish his work. Keep up the great work TrialSite.

  2. Ram Bahadur

    Why is not publishing data of completed trials of ivermectine’s for covid19?

  3. bh

    By the time the great and wise (being really sarcastic here) powers of the FDA and other such organizations approve the use of ANY treatment (low cost that is) for Covid-19, the pandemic will be over and it will not matter any more. And I agree with other opinions that these organizations love any drug promoted by by big Pharma. Big bucks = lots of love by the FDA. Saving live is the last thing they care about. Covering their big behinds is the first.

    • TrialSite

      Dear BH
      We have colleagues in high places in phrma that have been in clinical research for decades. They are great people and are well intentioned. They work in a system and it is this system that has grown, consolidated and expanded like an out of control blob. It gets to the point where it becomes kind of like a country club where certain members from industry, regulators and academia are at the cocktail party but all of those scrappy researchers, thinly capitalized upstarts or brilliant professors that don’t know how to play with politics: well they get left behind. And then there are the mindless zombies wandering around out there that the system feeds on…

      So a movement will grow for transparency, accessibility and competitive transformation as we see it even here at the TrialSite Network. You are part of it and we are grateful that you are here. Keep positive but critical; don’t try to change some people’s opinion that have already made up their mind or who are sort of too dense to think any other way or a patch of zombies.
      Think about the people you can reach for that one moment where the seed is planted and they never forget the idea. That no one can take away.
      Best Regards,
      Publisher

      • Ram Bahadur

        I think something conceal about ivermectine’s research by researchers or govt.
        Why doesn’t publish yet any data of trial study?

  4. Elijah

    I have now taken 2 schedules of Ivermectin and 30 grams of febendazole over the course of the last 3 months. I have never felt better in my life. I was researching these medicines to heal from apparent parasite infections. I believe profoundly in the Ivermectin RNA approach. It is derived from naturally occurring bacteria from the soil then fermented. This is preventative medicine and why our backward medical system won’t except this fashion of medicine. It’s like when doctors had to learn not to smoke in hospitals or to wash their hands. Our medical system is a joke when it come to preventative medicine. This is the #1 reason why communities outside of the United States are doing better. PREVENTATIVE NATURAL MEDICINE.

  5. Ron Carson

    The combination of Ivermectin, hydroxychloroquine, doxycycline,and zinc makes the most sense overall,as each molecule serves a different purpose. It makes perfect sense that this cocktail would eliminate the virus in a matter of days. This is what the Dr.s in south Florida are using.

    The key element to success is to administer it early. Don’t wait around 3-4 days for test results, because once the patient reaches a certain point it is no longer the virus that kills, but ones own immune system. Hit it early and hard !!!

    These are some of the safest drugs in the world. Literally tens of millions of people have been treated over the past fifty years with these drugs.

Pin It on Pinterest