In Pursuit of Real-World Ivermectin Stories: Tales from Pathanamthitta

Jun 17, 2020 | COVID-19, India, Ivermectin, Real World Evidence, Real-world data

In Pursuit of Real-World Ivermectin Stories Tales from Pathanamthitta

A request came from someone in the TrialSite Network out of India to look into a Times of India story reporting that a Pathanamthitta, Kerala-based health team has successfully treated six severe to critical COVID-19 patients with Ivermectin. The patients, including an elderly female hospitalized for 43 days due to SARS-CoV-2, were given the anti-parasitic drug which purportedly led to positive results. Four of the patients were admitted in March and two in April. Based on growing reports of success, the team initially administering 12 mg of Ivermectin on alternative days and they now report that all the patients test negative for COVID-19. Some gaps in information led a probe to other stories and a telephone interview. Does this latest observational data point equate to “real-world” evidence for Ivermectin as one possible treatment for COVID-19 patients?

Nestled inland near rainforest-covered, mystical mountains in southwest India, Pathanamthitta is a gorgeous place.  Well known for its “pilgrimage tours,” eco-tourism and various festivals, TrialSite News tapped into its network to learn more about how Ivermectin was being used successfully to treat COVID-19 patients. Approaching one million in the “TrialSite Network,” tens of thousands of readers reside in India. A tip was sent to review an article where a provider purportedly used Ivermectin to successfully treat COVID-19 patients

Issues with the Report

The Times of India article sent to TrialSite News didn’t disclose the name of the health care provider in the Kerala-based city adjacent to what could be deemed a paradise of natural landscapes. This seems strange. Why wouldn’t they share such important information? With a global pandemic where 8.3 million have been infected and nearly half a million dead, transparency, not the opposite, is important.

It was declared that the health team decided to use Ivermectin based on recent research studies. The impetus for the use of the drug was the early-stage lab experiment out of Monash University. This, of course, was critically important, where the Australian team disclosed the results of the use of ivermectin in cell culture in a laboratory. But this early-stage lab research can’t represent enough evidence to go directly to the clinic!

Of course, that creative scientific work out of Australia has led to interest worldwide but more evidence is required in the form of randomized controlled trials and complementary “real-world’ data from well governed observational treatment protocols.

Digging around Finds the Provider: Kozhencherry Hospital

TrialSite News probed into other reports on the Ivermectin story and found an actual hospital: Kozhencherry Hospital. A previous article from the Times of India in April disclosed not only the hospital but also the elderly female patient. Apparently it was 62-year-old Sherli Abraham who was hospitalized with COVID-19 for 48 days that was one of the patients given Ivermectin by doctors at the Pathanamthitta District Hospital, Kozhencherry. Initially a baffling case, she tested negative and then 20 subsequent test panels turned up positive. According to this article, it was Ivermectin that was her “saving grace.” The Pathanamthitta district medical officer quoted was Dr. Sheeja A.L. By May 6, apparently all of the COVID-19 patients were cured and released from the Pathanamthitta District Hospital.

TrialSite News researcher was able to connect with Dr. Sheeja on her cell phone, but a combination of faulty connection (on the doctors end) and accent led to a challenging communication and not a lot of useful information. However, the doctor did at least acknowledge that the patients were successfully treated with Ivermectin. However, the source of authority for ivermectin use was not clear and it was almost as if the doctor was hesitant to share more information.

What is the Evidence for Ivermectin Thus Far?

Based on the medical standard of evidence requiring the results randomized controlled trials, there is still absolutely no evidence that Ivermectin can be used to safety treat COVID-19 patients.  

With at least 26 formal, randomized clinical trials disclosed to Clinicaltrials.gov, only one trial has completed. The University of Baghdad sponsored a 100 patient Phase I clinical trial investigating the comparison of the efficacy of add on therapy of a single dose of 12mg Ivermectin to hydroxychloroquine (HCQ) and azithromycin (AZT) in COVID-19 patients versus a Non-Ivermectin group just having HCQ and AZT.

Led by principal investigator Gorial Faiq, a professor of Rheumatology at the University of Baghdad, TrialSite News was able to trade emails with the Professor. He reported that the study is complete and that the study team has submitted the results for publishing in a peer review academic journal. The investigator didn’t disclose any findings, good or bad. Hence, from the standpoint of evidence generated from randomized controlled trials, there is no publicly disclosed evidence that Ivermectin works.

What about Real-World Evidence?

If the definition of evidence is extended to include “real world evidence,” that is, data obtained from real world use cases involving observational data obtained outside the context of randomized controlled trials (often generated during some either routine or emergency clinical practice), the story starts to evolve to a different picture. 

TrialSite News researchers have been following various hospitals, health systems and physicians around the world as they administer Ivermectin to COVID-19 patients. In some cases, esteemed physicians are reporting “astounding results.”  From Dr. Tarek Alam’s findings at the Bangladesh Medical Hospital to Dr. Rajter’s observational effort at Broward Health in Florida, to government approval of Ivermectin out of Peru and Bolivia as well as news out of India that a growing number of medical providers have bought into the use of Ivermectin as a treatment that seems to be effective in cutting down the time of illness associated with COVID-19.

Conclusion

TrialSIte News has seen what is called the TrialSite Network grow to nearly 1 million strong, representing people interested in transparent and accessible research from around the world. With a number of requests to follow and pursue information about the potential of Ivermectin as a cost-effective and widely available potential treatment for the pathogen causing havoc around the world, the TrialSite News team has some exciting efforts undergoing now, including efforts on the ground in Peru where the drug has been approved by authorities to use in certain COVID-19 cases.

7 Comments

  1. Jason Milner

    Why is no one in the United States “free” press reporting This? If this is the cure why are we not using This? Seems no one cares if there is a cure.

    • TrialSite

      Dear Jason,
      Thanks for visiting TrialSite News. We have certainly asked ourselves this question. Could it represent such an outlier of a topic? An economical and accessible potential treatment that has a growing movement of medical proponents around the world. We have been monitoring the topic since we first read the Monash University/Doherty Institute lab research with interest. Through the monitoring we observed how interest in the drug grew in countries around the world. A couple of prominent U.S. universities have opened up studies. We aren’t certain why this hasn’t received more attention from the larger media outlets. Interestingly, we have experienced similar phenomena with other really important topics; we were certain the reporting would trigger attention and the exact opposite occurred: crickets. As an independently financed media platform, we have a certain flexibility. We will continue to monitor and report on the Ivermectin topic as we have been doing. Its’ fascinating–could an economical treatment for a good percentage of COVID-19 cases be right in front of us? Or will the sponsors of the current batch of clinical trials involving the drug ultimately report its influence is less than reported via real-world activity from multiple corners of the world today.. Only time will tell and TrialSite News will be there to share whatever findings we uncover. We appreciate your visit and comments.
      Regards,
      Publisher

    • Mark

      So much Money has been put into a vaccine and I believe the world health organization is waiting for that vaccine. A lot more money stands to be made from a vaccine than from of a cheap anti-parasitic.

  2. Marcos Yunaka

    Hi. In Brazil there is also a Doctor that is posting videos with consistent content.
    https://www.youtube.com/watch?v=Vy7outTf-H4
    Please do try to reach her and geather the infos about this ivermectin medication to treat covid19. Although this could be yet another hype, it could also be true. Maybe this would lead to a far less fatalities at treating covid19.

    • Mark

      Is there a version that is translated? To English

  3. John F Backus

    There is increasing evidence of a lack of transparency and perhaps even some altering of research and reports/testing with regard to some of these better known older medicines.

    There is just too much money involved to allow inexpensive medicines and treatments to be proclaimed as successful. For example:

    https://www.ageofautism.com/2020/06/who-solidarity-and-uk-recovery-clinical-trials-of-hydroxychloroquine-using-potentially-fatal-doses.html

    http://www.statnews.com/2020/06/04/lancet-retracts-major-covid-19-paper-that-raised-safety-concerns-about-malaria-drugs/

    Why is ivermectin very successful in the case of Covid-19. I think that this scientist offers the reason and these things are being ignored or silenced/covered up.

    After reading various articles AND particularly this scholarly article that immediately follows,
    I formulated the following opinion:

    [The key ideas (my interpretation) are:

    #1. The various ‘flu’ related vaccines have been creating a situation waiting to happen with regard to a pandemic in that there is evidence that these ‘activate’ the immune system to have a ‘storm’ response to the infection.

    #2. There are cheap and effective drugs that deal well with this ‘storm’ and it is this ‘storm’ that kills.

    Why is ivermectin so successful?
    It is interesting to learn that those who have experienced a ‘corona’ family type disease before **OR** have had
    a ‘corona’ flu type vaccine have been sensitized to react strongly in an allergic type response.
    A possible reason why the older and others are more susceptible to death from covid. ‘Those having immune
    “activated” systems is how one person once reported it. So, the various flu’ vaccines given to the poor most
    susceptible and older have been setting them up for a severe response to covid!

    As an individual, I do not have my own specific website, but I have been in contact with a scientist that publishes at http://www.ageofautism.com and it will suffice.

    I have been in corresponding with Mr. Vinu Arumugham. He shared with me something that he shared with one of his professors/mentors at the Beckman Center for Molecular Medicine who said about Vinu’s comments below:

    All very interesting.
    Congratulations to you for being correct, on point and prescient!

    Mr. Vinu’s comments as related to the abstract he published (and which I reference above), at:

    https://zenodo.org/record/3748304#.XurqwBOSmCh

    Mr. Vinu’s email to his mentor, June 6, 2020:

    Professor XXXXX,

    I have been predicting for 4 months now that mast cell stabilizers and antihistamines (like H1/H2 blockers) can help in COVID-19.

    I described the details, connecting mast cells, histamine, COVID-19 and dengue in my article below (uploaded Apr 11’20):

    Immunological mechanisms explaining the role of IgE, mast cells, histamine, elevating ferritin, IL-6, D-dimer, VEGF levels in COVID-19 and dengue, potential treatments such as mast cell stabilizers, antihistamines, Vitamin C, hydroxychloroquine, ivermectin and azithromycin
    https://doi.org/10.5281/zenodo.3748303

    As you may have read, famotidine (an antihistamine, H2 blocker) has been found to help in COVID-19, just like I predicted.

    A large group of experts with expertise covering drug discovery, vaccines, pathology etc. recently (May 24’20 report) hypothesized and investigated numerous potential mechanisms involved in famotidine’s beneficial effect in COVID-19. The study was funded by the “Department of Defense (DoD), Defense Threat Reduction Agency (DTRA), and the Joint Science and Technology Office (JSTO) of the Chemical and Biological Defense Program (CBDP) for funding under the Discovery of Medical countermeasures Against Novel Entities (DOMANE) initiative.”

    COVID-19: Famotidine, Histamine, Mast Cells, and Mechanisms
    http://www.researchsquare.com/article/rs-30934/v1

    They conclude: “We propose that the principal famotidine mechanism of action for COVID-19 involves on-target histamine receptor H2 activity, and that development of clinical COVID-19 involves dysfunctional mast cell activation and histamine release.”

    They write: ” … COVID-19 disease progression could share an immunologic basis with Dengue hemorrhagic fever” and

    “This model is also supported by the significant overlap in the clinical signs and symptoms of the initial phase of COVID-19 disease and those of mast cell activation syndrome (MCAS) 89-92 as well similarities to Dengue hemorrhagic fever and shock syndrome (including T cell depletion) during the later phase of COVID-19”

    “If COVID-19 is partially driven by dysfunctional mast cell degranulation, then a variety of medical interventions employing marketed drugs useful for treating mast cell-related disorders may help to reduce death and disease associated with SARS-CoV-2 infection. Examples include drugs with mast cell stabilizing activity, other histamine antagonists (for example H1 and H4 types), leukotriene antagonists and leukotriene receptor antagonists”

    In other words, their findings are in perfect agreement with my prediction and analysis.

    Thanks,

    Vinu