With approximately 3 million inhabitants, Lucknow is the largest city in the Indian state of Uttar Pradesh. Taking advantage of that state’s embrace of the anti-parasite drug Ivermectin as a supporting treatment for COVID-19, Lucknow’s municipal administration and health department formed a collaborative endeavor and set up 40 mobile kiosks throughout the city to freely distribute Ivermectin tablets to the city’s asymptomatic COVID-19 patients. With the greenlight from the state, local authorities seek economical and safe ways to treat the pandemic. This coincides with a well-known Australian physician-researcher calling for physicians in that country to consider using Ivermectin off-label with doxycycline and zinc or the Australian triple therapy.” In Bangladesh, the regimen is known as “the People’s Medicine.” Health department officials in Lucknow start handing out the medicine on Monday, August 24.
Uttar Pradesh Ivermectin Move
As TrialSite communicated to the global network, Uttar Pradesh state health officials recently decided against hydroxychloroquine opting for Ivermectin. Uttar Pradesh by itself would be larger than most nations with about 200 million residents.
Administration Full Throttle Tablet Distribution
The COVID-19 kiosks are placed around the city, such as at the airport, railway station and bus stations, reports the Hindustan Times. KP Singh serves as the district magistrate there; his involvement with local governance there spans nearly three decades, according to his LinkedIn profile. With his connectivity in this community, he would be well positioned to fully grasp the conditions there. Although he isn’t a physician, he was quoted, “The use of the Ivermectin tablet has proved effective for asymptomatic COVID-19 patients. It is also being widely prescribed by government doctors. Hence the administration, in collaboration with the health department, is setting up kiosks across the city to ensure its free distribution.”
The local press reports that the Ivermectin will be dispensed to those individuals who exhibit COVID-19 symptoms or to those who have come in contact with infected patients.
What is the Medical Basis for Ivermectin in Lucknow?
Dr RP Singh serves Lucknow as the chief medical officer for the municipality. Last week, the well-respected physician issued a circular that included the instructions for the amounts based on weight, their COVID-19 status, etc.
Much like in Peru, where TrialSite recently produced a documentary showcasing the Ivermectin status in that country, it would appear at least in Uttar Pradesh’s Lucknow that the basis for the conviction of the drug’s efficacy targeting SARS-CoV-2 is the University of Monash laboratory-based cell culture study.
For example, in explaining the rational for the choice of Ivermectin, Dr. Kauser Usman of King George’s Medical University, commented, “In Australia, researchers claimed the viral load went down 5,000 times in 48 hours with this medicine taken in combination.” In a reference to Dr. Tarek Alam, a physician at Bangladesh Medical College that TrialSite has interviewed, Dr. Usman commented, “A Bangladesh scientist claimed a similar effect.”
Meanwhile, Dr. PK Gupta, a formal president of the Indian Medicinal Association in Lucknow, chimed, “It is not a treatment for COVID-19, but yes as a supporting medicine, its role has been identified to boost immunity. It can be taken under a doctor’s guidance for proper dosage.”
Call for Real World Evidence
That Ivermectin is now widely in use as a “supporting” regimen throughout at least some states in India is not in question: TrialSite has chronicled its use in several hospitals and at least a few different states. The common anti-parasitic drug is used in many places now as a way to treat COVID-19.
Although over 30 clinical trials including Ivermectin are ongoing only two have been completed with results including one in Egypt and one in Iraq. Thus far there have been no takers for peer-review publishing. Observational or case series studies have also been completed including the Broward Health effort. Although hundreds of physicians have communicated the drug’s positive impact on treating COVID-19, there is not yet evidence required for Western societies to openly embrace the treatment.
Unfortunately, TrialSite has struggled to identify registries or any evidence or Real-World Evidence studies centering on current Ivermectin activities. Possibly due to the pandemic conditions, lack of resources and a host of other reasons, there needs to be more intervention to contribute back to humanity.
Real World Evidence (RWE)
RWE evidence is not as simple or straightforward as randomized controlled studies are. Why? Because RWE pursuit in many cases stumbles due to the complexities and “multiplicities” involved, such as health system stakeholders involved, real world measures plus methodical methods.
Hence what is needed, hopefully by the health authorities in Lucknow, is a commitment and focus to align stakeholders and their real-world measures for the use of Ivermectin targeting COVID-19 patients or those that have come into contact with such patients. Moreover, the team there would need to identify the design type, whether it be retrospective electronic health record analysis, medical chart analyses, prospective observational registries, or other approaches. TrialSite refers to an example authored by David Thompson, PhD, with contract research organization Syneos Health and his “Which Real-World Research Design is Best.”
Although growing real-world use showcases not only the growing use of Ivermectin in a bid to manage the COVID-19 pandemic conditions in low-to-middle-income countries (LMICs), such as Peru, Bolivia, Brazil, Dominican Republic, Bangladesh, India and others, TrialSite calls out attention to the need for at least RWE. Although not as strong from an evidentiary perspective, it nonetheless raises the seriousness of the matter in relation to Western discussions in medical and health care professional circles. The quest for demonstrable evidence must be a high priority now.