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.
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.
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.