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.
A 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.
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.