Pages

Showing posts with label Parasites/treatmeant. Show all posts
Showing posts with label Parasites/treatmeant. Show all posts

Tuesday, 26 January 2021

Ivermectin - An Unlikely Nation Is Kicking This Pandemic. Guess Which. Then Why.

 MUST READ - The use of Ivermectin in India and Bangladesh for Covid-19

An Unlikely Nation Is Kicking This Pandemic. Guess Which. Then Why.

By Mary Beth Pfeiffer

She is a gynecologist. He is a surgeon. They are married and both 77 years old. 

In mid-November, they were diagnosed with COVID-19, first her, then him. Their paths diverge at this point, but not to worry. 

She took the drug hydroxychloroquine. He took ivermectin. They are both well now – walking, golfing, doing yoga — seven weeks later.

The couple’s brush with COVID might have ended very differently. In the United States, patients 75 to 84 years old die at 220 times the rate of adults under 30. But these two elderly, otherwise healthy physicians live in India. They were able to get early home treatment that is virtually, and unconscionably, unheard of in many western countries.

“Without any treatment, we know that the virus enters the cells and replicates there,” Dr. Makarand Paranjpe told me by phone from his home in Pune, where he had quarantined through a fever and other symptoms. “They can create disease that gets much more severe.” Which, of course, is the point of treating early. Stop the progression. ASAP.

From the outset, India, a nation of both economic vigor and poverty, knew it had to act decisively. It did. India locked down early and long; it promoted masks, tested millions, and, as with the Pune couple, treated the infected early.

Ten months into its battle with the SARS-CoV-2 virus, India is on track to become an unexpected warrior in the fight against this global pandemic. Although the densely populated nation has four times the population of the U.S., India has less than half the U.S. COVID deaths. And India isn’t just beating the poorly performing U.S. In all, 98 nations have higher death rates than India.

It may be tempting to attribute this startling news to imperfect data from a developing country. But doctors in India, Indian press reports, and even the Wall Street Journal have taken note of a sea change in COVID there. “In September, India was reporting almost 100,000 COVID-19 cases a day, with many predicting it would soon pass the U.S. in overall cases,” the WSJ wrote on Dec. 30. “Instead, its infections dropped and are now at one-fourth that level.”

Dr. Anil K. Chaurasia, a physician in Lucknow, in the state of Uttar Pradesh, watched this trend unfold. Starting about mid-September, “a clear decline in COVID cases and fatalities in India was noticeable,” he told me in a text message. The “steep decline in cases and fatalities is still continuing.”

Like a lot of western reporting, the WSJ article held fast to an accepted COVID theme. The Indian miracle was due to masks, it asserted, since they are worn by 88 to 95 percent of a population “bombarded” with public-service reminders. The article cited German research that showed masks work. 

Fair enough. However, many factors are likely at play in India, including its painful yet supported national shutdown and individual state efforts at contact tracing and testing. But a pivotal role in any illness is surely the availability of treatments to resolve illness before crisis. 

Late last March, as the U.S. argued over the merits of Trump-endorsed hydroxychloroquine and studies failed in late-stage patients, India decided to recommend the drug in its national guidelines. HCQ “should be used as early in the disease course as possible…and should be avoided in patients with severe disease,” the directives wisely state. As a precaution, authorities suggested an EKG to monitor for a rare heart arrhythmia that several COVID studies have since shown to be minimal.

The Power Of One State 

But a crucial turn for India may have come in August when the Indian state of Uttar Pradesh recommended use of another drug: Ivermectin, which is coming on fast as a leading COVID treatment — without the baggage of at-turns effective but vilified hydroxychloroquine.

This was no small move. Were it a country, U.P.’s more than 230 million citizens would rank it fifth worldwide. As India’s largest state, its embrace of ivermectin may have changed the treatment landscape across India. 

“This authentication of ivermectin revived the faith of people,” Dr. Chaurasia told me, “and net result was a massive inclination to take these drugs” — both ivermectin and hydroxychloroquine.

By the end of 2020, Uttar Pradesh — which distributed free ivermectin for home care — had the second-lowest fatality rate in India at 0.26 per 100,000 residents in December. Only the state of Bihar, with 128 million residents, was lower, and it, too, recommends ivermectin. 

But Uttar Pradesh did more than treat 300,000 mild cases at home through 2020; it also opted to use ivermectin to prevent infection. It seems a young health officer’s COVID response teams had taken the drug and remained well – something prophylaxis studies support. U.P. then had contacts of COVID patients take it, with similar success. “Recognizing the sense of urgency,” Amit Mohan Prasad, a U.P. health official, wrote in a Dec. 30 article, “we decided to go ahead.”

Such urgency is in short supply in the U.S., where the single-minded focus is on vaccination. Nonetheless, a group of doctors called Frontline COVID Critical Care Alliance is pressing for adoption of ivermectin immediately as an adjunct and bridge to vaccination. Its logic is twofold: Ivermectin has a known safety profile, as a life-saving drug given to millions since the 1980s, and 46 COVID studies, including 18 peer-reviewed, have shown “high efficacy.” 

However, even India is holding back, perhaps temporarily. The Indian Council of Medical Research declined in October to recommend ivermectin nationwide, citing, as other such entities have, the need for more data. Similarly, COVID guidelines in bordering Bangladesh make no mention of the drug, despite successful studies done there.

In India, premier medical centers have, nonetheless, adopted it. In Bangladesh, doctors are using combination ivermectin/doxycycline therapy for home care, as are major hospitals in Dhaka for inpatients.

“The economy is flying,” Dr. Tarek Alam, who led several studies on the drug’s efficacy, told me in an email. “Hospitals have empty COVID beds and the initial demand for ICU has come down.” Indeed, Bangladesh – the world’s most densely populated country — has an even lower fatality rate than India, ranking 126th globally.

Tipping Point? 

Significantly, ivermectin received a tentative endorsement recently in research funded by the World Health Organization-hosted program Unitaid. After analyzing 11 randomized control studies, Dr. Andrew Hill concluded: “If we see these same trends consistently across more studies, then this really is going to be a transformational treatment.”

The agency is publicly acknowledging movement. “Preliminary data is promising,” Herve Verhoosel, a spokesman, wrote in a statement, “but there is the need to await the results of further trials before determining next steps.”

More information is always better. But at what point, in a pandemic, is there enough?

Last spring, when COVID was new, Dr. Dhananjay Bakhle, an M.D. in pharmacology in Pune, observed something. “Many doctors were afraid to use HCQ,” he told me. “I was appalled since the solution was available.” He began treating infections among 15,000 workers of the pharmaceutical company where he directs medical research. Just 3 of 270 patients were hospitalized; he said, and none died.

“I trusted HCQ from the beginning,” Bakhle told me, “and I didn’t trust ivermectin.” He was unsure both of dosing and how the anti-parasitic drug worked. So he did studies in his own laboratory, to test the drug’s anti-viral mechanism, that he hopes to publish. “I changed my mind about Ivermectin in the last three to four months.” Still, he sees HCQ as his top choice, while adding ivermectin frequently. He uses the drug alone when HCQ is contraindicated.

That was the case with his cousin Dr. Paranjpe, who Bakhle treated in consultation with another physician. 

Did the drug make the difference for him, I asked Dr. Paranjpe.

“I can’t pinpoint if it was because of ivermectin,” he said. He also took doxycycline, zinc, aspirin, quercetin and, starting on day nine, the steroid dexamethasone for inflammation. While his wife, Meera, had a mild and quickly resolved infection with HCQ, he suffered through days of low fever and body pain. Paranjpe may not know for sure what worked, but he does know this: He was happy to get early treatment at home In India. “Definitely, it is helping,” he said.

A few days later he emailed an update. “Meera and myself, we both are feeling completely normal,” he wrote. “There are no residual symptoms.” 

I’ll end this with the Worldometer COVID statistics for Jan. 7, 2021.

India

  • New Cases: 18,106
  • New Deaths: 234

United States

  • New Cases: 279,154
  • New Deaths: 4,207

***

Mary Beth Pfeiffer is an investigative journalist and book author. Read her other COVID articles here. Follow her on Twitter: @marybethpf.

TrialSite Editor Comment 

Importantly, the national laws, cultures and approaches are in fact, quite different between India and the United States. As TrialSite is a United States-based digital media platform, importantly we share that the proper path forward for acceptance of a new treatment approach is via the National Institutes of Health (NIH) COVID-19 Protection Treatment Guidelines. TrialSite doesn’t endorse any particular approach but rather seeks to provide unbiased, independent news, information and opportunity to bring more transparency and accessibility to research, with the aim of advancing biomedical research to benefit all humanity.

Currently, Ivermectin is recommended only for research and has a rating of AIII. Although we have been constructively critical of what is a national research treasure, TrialSite recently commended the Panel for inviting members of the Front Line COVID-19 Critical Care Alliance (FLCCC) and Dr. Andrew Hill, a consultant associated with the University of Liverpool in the UK, to present their findings to date. 

This was an important milestone as the Panel associated with that apex national research agency now looks into the accumulating data. The NIH’s Panel will hopefully consider risk-based approaches (much like they have done with highly novel monoclonal antibodies), seeking a way to ensure early-stage treatment in combination with the vaccine rollout over the next year. 

In parallel, other mission-critical agencies such as the Department of Defense could potentially benefit from economical approaches to both pre-exposure prophylaxis (PrEP) as well as post-exposure prophylaxis (PEP). We encourage multiple pathways toward that end, from promising research from AstraZeneca (AZD7442—originating from some brilliant researchers at Vanderbilt and the company) to innovative approaches such as the large United Health and Lilly home-based clinical trial to the potential of Ivermectin as a generic treatment. 

Fully overcoming COVID-19 in the USA necessitates a combination of more harmonized behavior (e.g., social distancing, masks, etc., across the 50 states) plus effective early stage as well as later-stage treatments and, of course, the vaccines. With two vaccines currently authorized on an emergency basis, other promising ones could be underway sooner rather than later. 

The broader economy, society as well as health and vitality of the nation—one that importantly sets a precedent for so many positive forces around the world— benefits from an open, proactive, and progressive approach that includes a dynamic interchange between research, regulatory, the clinic and caregiver—driven by an unbiased recognition of the accumulating data inspired by the most rational of decision making. The NIH made such a move the other day. 

https://trialsitenews.com/an-unlikely-nation-is-kicking-this-pandemic-guess-which-then-why/



Trending News



Saturday, 23 January 2021

Oxford’s PRINCIPLE Trial: Bringing Ivermectin Directly into the Developed World in the Battle Against COVID-19

Researchers at Oxford University are planning the first, large high-quality trial of a cheap drug that has been credited with dramatically reducing Covid-19 deaths in the developing world.

The Principle trial is hunting for treatments that could be used at home soon after symptoms appear. The aim is to find a medicine that makes an impact during the earliest stages of disease, preventing severe illness.

The next batch of medicines it will assess will include ivermectin. Used for decades to treat livestock and people infested with parasitic worms, it has been hailed as a Covid “wonder drug” by supporters. However, many other scientists say that it is yet to be properly evaluated.


https://www.thetimes.co.uk/article/trial-for-covid-wonder-drug-that-could-save-thousands-of-lives-99jc07v2s


Ivermectin, used for decades to treat livestock and people infested with parasitic worms, has been hailed as a Covid “wonder drug”
MAHESH KUMAR/AP


The University of Oxford soon kicks “the PRINCIPLE Trial” into a higher gear now, in what they consider a pathbreaking “high-quality trial” of Ivermectin, a generic drug already evidencing significant efficacy in over two dozen clinical trials around the world, according to some researchers. 

The UK government also backs this pivotal study via the Department of Health and Social Care. Searching for early-onset, home-based ambulatory treatments for COVID-19, the PRINCIPLE Trial seeks to meet a gap in research in the world’s richest nations to date. 

Nearly all of the taxpayer-financed research-based expenditures of governments in the US, UK and Europe, for example, have gone into vaccines, novel monoclonal antibodies, and novel therapeutics, with an emphasis on treating severely ill patients. 

Ivermectin, hailed as the “wonder drug” or “the People’s medicine” for COVID-19, gains growing attention worldwide made more widely available, frankly, partly due to TrialSite’s consistent chronicling of these trials around the world since the original University of Monash breakthrough. 

The team discovered that in a lab cell culture, Ivermectin obliterates the novel coronavirus within 48 hours. Since then, TrialSite has covered most studies worldwide, whereas, by the summer, groups in the U.S., such as the Front Line COVID-19 Critical Care Alliance (FLCCC), commenced meta-analysis covering the dozens of Ivermectin studies around the world. 

According to these physician/scientists, the results reveal compelling data that Ivermectin actually reduces the COVID-19 death rate while accelerating viral clearance and transmission reduction. 

Enter the preeminent University of Oxford and the PRINCIPLE Trial: the globe’s top investigators now seek to finally test if Ivermectin and antiviral Favipiravir, both low-cost, orally-administered, generally available generic drugs, can be proven safe and effective in a “properly designed trial.” 

Led by Co-Chief investigator Chris Butler, Professor of Primary Care, Nuffield Department of Primary Care, Health Services at Oxford, the study team is generally upbeat about the prospects. Still, Dr. Butler notes the “gap in the data.” 

A critically important trial, the PRINCIPLE Trial, is also causing a stir. Groups such as the FLCCC raise the Helsinki Accords: from their vantage, they remind all about the question of ethical conduct—is it right and proper to conduct a randomized placebo-controlled trial when there is sufficient evidence that a drug can save lives? 

Couldn’t a dose control study or well-designed observational study be run instead to both generate data and protect patients? 

On the other hand, that Oxford is the first major center to embrace this important generic drug is truly game-changing and demonstrates the leadership position of that research institution again.

‘Not a Great Place to be’

On Saturday, The Times’ scientific correspondent Rhys Blakely rightly identified growing frustration worldwide with apex research agencies such as the American National Institutes of Health (NIH) and a number of funding governments use of taxpayer money. In the U.S., for example, Operation Warp Speed, in conjunction with the NIH’s ACTIV, has spent over $13 billion of taxpayer money on just a handful of vaccine and novel monoclonal antibody developers, yet the nation has experienced a staggering amount of death from the pandemic.

A growing cry by physicians and other medical professionals for drugs that can be used at the early onset of the virus, to impede the progression of infectious severity, hasn’t been reflected in the research spent to date.

But other nations have commenced with programs to treat early-onset treatments with antivirals or Ivermectin. Albeit, these tend to be low-to-middle-income countries (LMICs) with far fewer resources than would be available in America, Britain or Europe, for that matter. These poorer countries must be ever more resourceful—they don’t have many billions of dollars to spend during a pandemic on lengthy, randomized, placebo-controlled studies. 

Russia led a series of agile studies that led to the approval of Favipiravir, as has India (with multiple generic versions), and several other countries. Ivermectin is used in India’s state of Uttar Pradesh, with 210 million people, health officials there swear by the results. The same is occurring in some Brazilian states, Bangladesh, and for that matter, Peru and Argentina. TrialSite commissioned a documentary about this unfolding situation in Peru. In Europe, at least in the south eastern fringe, the use of Ivermectin gains steam in Greece and the Balkan Peninsula.

Frustration Enters the “First World”

But the “First World” that is the wealthiest Western nations have experienced some of the most horrific losses from this pandemic. The U.S. has been the epicenter of the pandemic, with over 400,000 deaths.

The Times’ Blakely spoke with Wellcome Trust’s Nick Cammack, who shared that there are only “…two strong new antiviral candidates in the pipeline to date. One is called molunpiravir (EIDD-2801) from Merck.” Taken via tablet form and reported on by TrialSite, it is apparently designed to actually “…interfere with an enzyme that the virus relies on to replicate.” Cammack shares that if the clinical trials perform, the drug could be available toward Q3 2021.

Dr. Cammack also introduced Roche’s AT-527, another antiviral drug that is early in the pipeline. This gap, Cammack frets is, “…worrying.” That is, “To have only a few potential therapeutics for a nasty disease during a global pandemic—it’s not a great place to be. We need a big push in R&D.”

In the United States, TrialSite was one of the only media at the time to report on the breakthrough findings of the ICON study in Broward County, Florida. There, Dr. Jean-Jacques Rajter and the team from Broward Health discovered amazing results from the ICON observational study, which evidenced, among other things, that Ivermectin could lower the COVID-19 death rate. The results were finally published in CHEST, but they were not considered strong enough as ICON was observational and not a randomized, placebo controlled study.

Many doctors in the U.S. started prescribing off-label, and with every trial result that TrialSite reported on, the data gained strength. There was some mounting evidence that Ivermectin definitely could inhibit the coronavirus. TrialSite for months called out for NIH funding of Ivermectin studies: the online media platform’s founder even wrote an urgent email communication to NIH Director Francis Collins.

Enter Oxford’s PRINCIPLE Trial

Perhaps there is no stronger brand in research than that of Oxford University. One of the world’s most renowned investigational hubs, this prominent group, led by Dr. Peter Horby, conducted the RECOVERY trial, which showcased and found the benefits of corticosteroids in more severe COVID-19 cases. Backed by the UK government, now The PRINCIPLE Trial seeks to confirm whether low-cost, easy-to-administer drugs such as Ivermectin and Favipiravir can truly inhibit the coronavirus.

In the recent The Times article, journalist Rhys Blakely interviewed Co-Lead investigator Dr. Butler who acknowledged that Ivermectin “…Has potential antiviral properties and anti-inflammatory properties, and there have been quite a few smaller trials conducted in low-and-middle-income countries, showing that it speeds recovery, reduces inflammation and reduces hospitalization…”

“The Data Gap”

TrialSite has now chronicled many dozens of Ivermectin trials around the world—randomized controlled trials, observational studies and case series total near 75, while at least 50 randomized controlled trials and observational studies have occurred worldwide. The FLCCC, based out of the U.S., maintains a meta-analysis of a couple dozen Ivermectin studies, covering about 2,000 patients.

According to this group, the existing data leads to a clear-cut case of evidence for A.) additional dosing studies and B.) emergency use authorization as lives need to be saved now. Already, over 400,000 lives in the U.S. have been lost, despite over $13 billion in taxpayer-supported major clinical trials, primarily targeting vaccines and novel monoclonal antibodies.

But this isn’t enough for what is considered by the biomedical research establishment, including the prominent University of Oxford. The studies in places like Bangladesh and Columbia; Egypt and Argentina; Iraq and India; and Mexico and other LMICs aren’t sufficient. Be it flawed, study design, too much dosing variability, or not sufficient numbers of patients, the evidence must be established elsewhere. That significant groups in America and Britain have studied these underlying studies, and assembled meta-analyses pointing to strong data for efficacy isn’t good enough for the apex research institutes and the West’s major academic medical centers.

While some groups such as the FLCCC call for immediate emergency use authorization and dose-finding studies, the major research center scientists and principal investigators, as well as health authorities, still see a gap in the data that must be filled.

As expressed by Dr. Butler with Oxford “…There’s a gap in the data. There’s not been a really rigorous trial.”

For that matter, neither does Rockstar Principal Investigator Peter Horby, also with Oxford. Dr. Horby led the RECOVERY trial, proving that dexamethasone could reduce COVID-19 death rates, at least in severe scenarios. According to this world-renowned principal investigator, the data covered in the meta-analyses was “interesting, perhaps encouraging, but not yet convincing,” reported Blakely with The Times.

The Study

First, TrialSite commends University of Oxford, the British government and Dr. Butler for progressing this study. No matter the critique that follows, Oxford and the Butler study team were the first to declare the intention to take on this mission-critical effort among the highly industrialized nations of the “West.” That the PRINCIPLE Trial’s leadership embrace both Ivermectin and Favipiravir is a big deal.

In a quest to finally establish safety and efficacy for a low-cost drug that can work earlier–that is, right when COVID-19 symptoms appear, Professor Butler and team seek to establish if Ivermectin can prevent viral replication, thus stopping the SARS-COV-2 pathogen from entering the human host, reports The Times.

Called The PRINCIPLE Trial (ISRCTN86534580), study details can be found here.

The study will employ a number of channels to recruit patients, from GPs and online to contact-tracing systems in Britain to find patients that are either A.) 65 and up or B.) 50 and up, experiencing health conditions that could pose a greater risk.

Study Flaw?

The Times reports that some experts such as Penny Ward, visiting professor in pharmaceutical medicine at Kings’ College London critiques the study, sharing with The Times’ Rhys Blakely that, “They’re allowing a recruitment window 14 days from the onset of symptoms, but the virus peaks on day three—and it’s too late to use an antiviral after the peak of virus replication.”

Dr. Ward continued for The Times, “And if you don’t intervene very rapidly with an antiviral, you will have a failed trial—even though the drug itself might, in fact, have been effective if given correctly. If they do get the skates on and get patients into those trials within two or three days of the first onset of symptoms, then there’s a fighting chance that one or two of those might actually be effective.”

Ethics of this Study Questioned by Some?

On Saturday TrialSite interviewed the head of the FLCCC Dr. Pierre Kory on their position on this study. He shared that although they were pleased that The Times reporter considered their point of view, their full quotes from Dr. Paul E. Marik were precluded from the article.

The FLCCC is adamant about the need for more Ivermectin research; however, based on the principles of the Declaration of Helsinki, Kory articulates, “it’s unethical to use a placebo-based study when the evidence is clear that a medicine actually works.” Because that means that people can become more ill and even die with the foreknowledge that the medicine could be used to save those very lives. 

In the interview, Dr. Kory was very clear that the evidence favors immediate emergency use of Ivermectin at least, and that any study should be designed as a dose-finding study, for example, and well-designed observational study establishing the anti-parasite medicine as standard of care, measuring the differing outcomes utilizing sophisticated propensity matching and access to Big Data for full analytics.

Discussion with the FLCCC about Why LMICs Clinical Trials Not Accepted

TrialSite raised the present challenges to the findings of the existing studies. Referring to those studies that have been conducted around the world and that are captured in the meta-analysis efforts led by the FLCCC, another effort in the UK led by Dr. Andrew Hill, and even another one in Britain led by Tess Lawrie.

Why do Dr. Butler, Dr. Horby and so many other scientists and researchers not accept the evidence that’s been generated to date? It comes down to a few key factors such as the following:

  • The present studies don’t include enough patients
  • They are not well-designed trials
  • Variability in dosing in the studies

In regard to the number of patients, Kory noted that at least 2,000 patients are now covered by the meta-analyses created in both America and the UK. He shared that a meta-analysis—that is, an analysis of many underlying Ivermectin-based COVID-19 clinical trials—represents the strongest form of evidence.

He pointed out that the meta-analysis is stronger than any single underlying trial. The FLCCC’s reading of their meta-analysis of Ivermectin studies is clear: the low-cost medicine has a significant impact on mortality, viral clearance and viral transmission.

But what about the critique that these studies from LMIC’s are not “well designed?” For example, the dosage amounts vary across the dozens of studies. Dr. Kory shared this critique is strange, if not senseless. He pointed out that dosage variability schemes are actually good; they evidence differing forms of efficacy and actually contribute to the quest for the ultimate dosing strategy. Kory suggested compelling research at this point would be a dose-finding study.

Okay, on to the critique that the underlying LMIC-based studies were not well designed? Some of the Ivermectin studies, critics point out, were open-label, leading to possible bias.

That these studies could be influenced by subjective bias because some of them were open-label, for example? Kory acknowledged that open-label studies could lead to bias and hence, influence subjective outcomes. But he hammered on the point that the objective outcomes identified cannot be influenced by this kind of bias—that is, the actual reduction in mortality rate, viral clearance and the like are objective measures regardless.

Heavy Burden

Because the FLCCC physicians are convinced the meta-analyses research from both sides of the Atlantic points to a clear case of efficacy, they worry about the control group patients. As the group maintains that the existing evidence for Ivermectin is overwhelmingly indicative that the medicine is highly effective in reducing hospitalization, inhibiting transmission and lowering COVID-19 death rates as well as accelerating viral clearance, they cannot morally support a placebo-controlled study at this point.

They believe it’s a mistake and that the Oxford PRINCIPLE Trial should be designed as a dose-finding study and/or sophisticated observational study. Kory told TrialSite, “It is grossly unethical to enroll patients in a placebo-controlled trial. Such a study will lead to harm to the control group.” What he means is that from their perspective, because the drug is known to work, purposely not giving the control group that drug brings a heavy burden on those funding and designing the study.

Conclusion

TrialSite has emerged as a prominent objective, unbiased online daily for clinical trials, emphasizing transparency, accessibility and a focus on the trial site organization (that is, the investigational site at the hospital, clinic or commercial center).

With the aim of advancing biomedical research, TrialSite has led all media in identifying and tracking Ivermectin studies during the pandemic. TrialSite isn’t a scientific journal, nor does it exist to promote one opinion or perspective. Nor is it an authority on what is evidence. It’s merely a daily online news channel for those interested in research. The goal is to identify, track and monitor research, with the aim of helping empower more health care consumers, physicians and healthcare professionals with daily updates to research.

Consequently, TrialSite cannot opine on whether the PRINCIPLE Trial is ethical or not. TrialSite commends Dr. Butler, University of Oxford, and the UK government for funding this important research endeavor. It’s the very first major clinical trial in the G8, for example, to embrace Ivermectin. As mentioned previously, a TrialSite founder sent an urgent request letter to the NIH, only to receive no response. 

On the other hand, the FLCCC is too commended by TrialSie for their commitment, dedication, and passion to saving lives during this pandemic. FLCCC members are putting their careers on the line for the mission-critical cause of saving lives during this pandemic, which has already taken over 400,000 in America and over 2.1 million deaths worldwide.

Hopefully, Dr. Butler and team can execute the trial to conclude early should sufficient efficacy data be observed early on. And get on with treating people when and if they deem such evidence sufficient.

Lead Research/Investigator

Chris Butler, BA MBChB, DCH, CCH, MD, FRCGP, (Hon)FFPH, FMedSci, Professor of Primary Care, Nuffield Department of Primary Care, Health Services, Co-Chief investigator

Call to Action: TrialSite follows studies across many different therapeutic areas. Have any requests? Contact us.

https://trialsitenews.com/oxfords-principle-trial-bringing-ivermectin-directly-into-the-developed-world-in-the-battle-against-covid-19-2/


Trending News

Latest Podcasts