A year. Bummer. Why does it take so friggin' long? :( :( :(
The investigational interest in common and economical anti-parasitic drug ivermctin (Stromectol) continues to grow now as the prestigious Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins plans to launch a clinical trial in June. In hospitalized patients with SARS-CoV-2, the virus behind the COVID-19 pandemic, the Baltimore, Maryland-based investigators will compare the standard of care with bicalutamide or ivermctin. They are joining a growing group of research centers in a search for effective and safe treatments. This group is taking a noticeably different approach than the University of Kentucky study, which focuses on patients at home with milder cases of COVID-19.
A growing number of research centers around the world are investigating the use of ivermctin as a potential therapy targeting SARS-CoV-2. The idea started thanks to a group of creative and out-of-the-box thinking scientists in Australia. The word spread and now a number of companies, academic medical centers, and governments are exploring the use of the anti-parasitic drug as a possible therapy. The upside could be huge: the drug is inexpensive and available. In fact, Merck even helps developing nations by giving the drug, called Stromectol, away in some cases. Now Johns Hopkins investigates ivermctin and an anti-androgen drug known as Bicalutamide—used together or with another hormone to treat prostate cancer.
The Study
Planned to commence June 2020 for a year, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins will probe into whether bicalutamide or ivermctin can have an impact on hospitalized patients infected with SARS-CoV-2. Led by Principal Investigator Catherine H. Marshall, MD, MPH, and a team of sub-investigators listed below, the team will study two groups including one randomized group receiving Bicalutamide Casodex) 150 mg by mouth daily for seven (7) days versus plus the standard of care for COVID-19 versus the use of versus a study group receiving ivermctin (Stromectol/Soolantra/Sklice) 600 µg/kg (maximum dose of 60mg) by mouth daily for three days with the possibility of extension to six (6) days if still hospitalized and approved by the Data and Safety Monitoring Board.
A year? Are they serious? How long did it take them to conclude with Remdesivir? Millions of people could potentially die from COVID-19 within the next year. We already KNOW that Ivermectin works, we just don't know to what extent!
This is the trial, originally titled "Trial to Promote Recovery From COVID-19 With Ivermectin or Endocrine Therapy", now titled "Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)".
I noticed that the number of trials registered for ivermectin went from 33 to 32 and had a bad feeling. (Every time I wonder why, it's not that hard to imagine. The fix is in, as the old saying goes.)
I hate conspiracy theories, and always prefer to assume that things happen for good reasons. This is suspicious, though. The Hopkins study was the only US trial looking at ivermectin -- and it's the only trial to remove ivermectin.
I'm going to email one of the researchers and ask why ivermectin was removed.
Edit: I sent this
Subject: Why did you decide to remove ivermectin from your trial?
Hi, Dr. Marshall,
I am closely following ivermectin research, and I'm disappointed to learn that you are not going to be looking at ivermectin in your trial named (as of today) "Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)".
Would you be so kind as to explain why you dropped the ivermectin arm of your trial?
The trial has been underway since May 5. Did your results so far indicate that ivermectin is not effective? Surely that would be worth reporting. Were patients doing so badly that it was irresponsible to continue the ivermectin arm?
There are now 32 trials looking at ivermectin vs covid-19 on ClinicalTrials.gov. There are at least 10 trials registered elsewhere. There is only 1 trial, yours, looking at bicalutamide.
I'll be very interested, if you will please share your reason for dropping ivermectin.
Who am I? Nobody, really, just a retired software engineer who has time enough to scour the internet looking for all things ivermectin, which I (and others) gather here:
https://www.reddit.com/r/ivermectin/
There are almost 350 posts there: trial descriptions, news articles, a handful of completed studies. I'm biased, I admit, but so far ivermectin looks very promising. If you are interested, let me know and I'll send you links to the three trials that have published results. I'll also admit that the three trials have problems. That's why I was so looking forward to the results of your study!
Thanks in advance for whatever information you are willing to share.
- Name (TrumpLyftAlles on reddit -- an embarrassing username chosen on a whim)
Edit: I got a reply but not an answer to my question.
~~Which unfortunately isn't much, just ivermectin as an optional treatment in the mildest cases -- despite the protocol citing the ICON study which found that ivermectin reduced fatalities 52% for the most severely-ill patients. :(~~
Check out the changes to the Kentucky trial - they are looking at ivermectin on its own, rather than in combination with HCQ (though still no control arm?) and they added artemisia annua, which is fascinating.
Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial.
??? I googled 'ivermectin AND (wormwood OR "artemisia annua")' and found a bunch of links about the 2015 Nobel Prize citing research into wormwood / artemisia annua but nothing relating it to ivermectin directly.
Why do you suppose? Apparently some people are allergic to ivermectin. If that was their concern, then why wouldn't "allergic to ivermectin" be an exclusion criterion, directly?
Oh: ivermectin is a macrolide, which is among the exclusion criteria.
Edit: How do Mass Drug Administrations to 540 million people (in 2019 alone) work if some people are allergic? Maybe the allergic reactions are mild?
I don't know about the exclusion criteria. All I know is that artemisia is an antimalarial. The plant is artemisia annua and various pharmaceuticals were developed from it, including artemisinin (available OTC) and artesunate. Artemisinin also led to a nobel prize.
When you wrote "U of Kentucky" I thought you meant the University of West Virginia protocol. Damn my feeble brain! I had forgotten that UK was doing a trial. Thanks for the follow up!
Armed with the link to the old trial (thanks, elkrange), I also sent this:
Hi again, Dr. Marshall,
I found the link to the original trial. The ivermectin treatment of 600mcg/kg was just right, IMO. If memory serves, another trial is looking at that dose, and another is looking at both 600mcg/kg and 1200mcg/kg (!!).
Did you observe Central Nervous System effects?
As you are very likely aware, this study:
Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects
Looked for CNS toxicity and found none with the highest tested dose.
Ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 microg/kg.
I write this in the very faint hope that this is new information that might lead to your reversing your decision to drop the ivermectin arm of your trial.
If the results are extremely promising, it will be announced early- maybe by mid summer. The study goes for a year while the authors continue gathering data. If early data is reveals this will save lives, there is no doubt that information will be shared.
[-] TrumpLyftAlles | 1 points | May 14 2020 18:34:21
This is a news story about a study registered at ClinicalTrials. If is the only registered trial looking at Bicalutamide.
Planned to commence June 2020 for a year
A year. Bummer. Why does it take so friggin' long? :( :( :(
The investigational interest in common and economical anti-parasitic drug ivermctin (Stromectol) continues to grow now as the prestigious Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins plans to launch a clinical trial in June. In hospitalized patients with SARS-CoV-2, the virus behind the COVID-19 pandemic, the Baltimore, Maryland-based investigators will compare the standard of care with bicalutamide or ivermctin. They are joining a growing group of research centers in a search for effective and safe treatments. This group is taking a noticeably different approach than the University of Kentucky study, which focuses on patients at home with milder cases of COVID-19.
A growing number of research centers around the world are investigating the use of ivermctin as a potential therapy targeting SARS-CoV-2. The idea started thanks to a group of creative and out-of-the-box thinking scientists in Australia. The word spread and now a number of companies, academic medical centers, and governments are exploring the use of the anti-parasitic drug as a possible therapy. The upside could be huge: the drug is inexpensive and available. In fact, Merck even helps developing nations by giving the drug, called Stromectol, away in some cases. Now Johns Hopkins investigates ivermctin and an anti-androgen drug known as Bicalutamide—used together or with another hormone to treat prostate cancer.
The Study
Planned to commence June 2020 for a year, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins will probe into whether bicalutamide or ivermctin can have an impact on hospitalized patients infected with SARS-CoV-2. Led by Principal Investigator Catherine H. Marshall, MD, MPH, and a team of sub-investigators listed below, the team will study two groups including one randomized group receiving Bicalutamide Casodex) 150 mg by mouth daily for seven (7) days versus plus the standard of care for COVID-19 versus the use of versus a study group receiving ivermctin (Stromectol/Soolantra/Sklice) 600 µg/kg (maximum dose of 60mg) by mouth daily for three days with the possibility of extension to six (6) days if still hospitalized and approved by the Data and Safety Monitoring Board.
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[-] kunkr | 2 points | May 14 2020 19:03:18
A year? Are they serious? How long did it take them to conclude with Remdesivir? Millions of people could potentially die from COVID-19 within the next year. We already KNOW that Ivermectin works, we just don't know to what extent!
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[-] elkrange | 2 points | Jul 16 2020 16:44:19
It looks like the Johns Hopkins study deleted ivermectin.
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:15:50
Great catch. How did you figure that out?
This is the trial, originally titled "Trial to Promote Recovery From COVID-19 With Ivermectin or Endocrine Therapy", now titled "Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)".
Discouraging. :(
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[-] elkrange | 2 points | Jul 16 2020 18:18:55
I noticed that the number of trials registered for ivermectin went from 33 to 32 and had a bad feeling. (Every time I wonder why, it's not that hard to imagine. The fix is in, as the old saying goes.)
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:25:43
And then you had to figure out which one went away. Nice work.
Next time please include the link to the trial. I had to figure it out too. ;)
It's this trial.
Hopefully there won't be a next time.
The fix is in, as the old saying goes.
I hate conspiracy theories, and always prefer to assume that things happen for good reasons. This is suspicious, though. The Hopkins study was the only US trial looking at ivermectin -- and it's the only trial to remove ivermectin.
I'm going to email one of the researchers and ask why ivermectin was removed.
Edit: I sent this
Subject: Why did you decide to remove ivermectin from your trial?
Hi, Dr. Marshall,
I am closely following ivermectin research, and I'm disappointed to learn that you are not going to be looking at ivermectin in your trial named (as of today) "Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)".
Would you be so kind as to explain why you dropped the ivermectin arm of your trial?
The trial has been underway since May 5. Did your results so far indicate that ivermectin is not effective? Surely that would be worth reporting. Were patients doing so badly that it was irresponsible to continue the ivermectin arm?
There are now 32 trials looking at ivermectin vs covid-19 on ClinicalTrials.gov. There are at least 10 trials registered elsewhere. There is only 1 trial, yours, looking at bicalutamide.
I'll be very interested, if you will please share your reason for dropping ivermectin.
Who am I? Nobody, really, just a retired software engineer who has time enough to scour the internet looking for all things ivermectin, which I (and others) gather here:
https://www.reddit.com/r/ivermectin/
There are almost 350 posts there: trial descriptions, news articles, a handful of completed studies. I'm biased, I admit, but so far ivermectin looks very promising. If you are interested, let me know and I'll send you links to the three trials that have published results. I'll also admit that the three trials have problems. That's why I was so looking forward to the results of your study!
Thanks in advance for whatever information you are willing to share.
- Name (TrumpLyftAlles on reddit -- an embarrassing username chosen on a whim)
Edit: I got a reply but not an answer to my question.
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[-] elkrange | 2 points | Jul 16 2020 18:30:20
There's still U Kentucky
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:38:50
~~Which unfortunately isn't much, just ivermectin as an optional treatment in the mildest cases -- despite the protocol citing the ICON study which found that ivermectin reduced fatalities 52% for the most severely-ill patients. :(~~
Disregard comment; brain broken.
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[-] elkrange | 1 points | Jul 16 2020 18:44:35
Check out the changes to the Kentucky trial - they are looking at ivermectin on its own, rather than in combination with HCQ (though still no control arm?) and they added artemisia annua, which is fascinating.
https://clinicaltrials.gov/ct2/history/NCT04374019?A=2&B=3&C=Side-by-Side#StudyPageTop
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:54:53
Exclusion criteria:
Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial.
??? I googled 'ivermectin AND (wormwood OR "artemisia annua")' and found a bunch of links about the 2015 Nobel Prize citing research into wormwood / artemisia annua but nothing relating it to ivermectin directly.
Why do you suppose? Apparently some people are allergic to ivermectin. If that was their concern, then why wouldn't "allergic to ivermectin" be an exclusion criterion, directly?
Oh: ivermectin is a macrolide, which is among the exclusion criteria.
Edit: How do Mass Drug Administrations to 540 million people (in 2019 alone) work if some people are allergic? Maybe the allergic reactions are mild?
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[-] elkrange | 2 points | Jul 16 2020 19:14:20
I don't know about the exclusion criteria. All I know is that artemisia is an antimalarial. The plant is artemisia annua and various pharmaceuticals were developed from it, including artemisinin (available OTC) and artesunate. Artemisinin also led to a nobel prize.
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 19:27:20
That's the same year that the same prize was given to Campbell and Omura for their ivermectin work!
That's why (the light dawns) searching for ivermectin AND artemisia turns up the Nobel Prize hits.
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 19:10:15
When you wrote "U of Kentucky" I thought you meant the University of West Virginia protocol. Damn my feeble brain! I had forgotten that UK was doing a trial. Thanks for the follow up!
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[-] elkrange | 2 points | Jul 16 2020 18:32:51
In case anyone is wondering, the historical version of the trial, with ivermectin, is available here: https://clinicaltrials.gov/ct2/history/NCT04374279?V_1=View#StudyPageTop
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:37:31
Your google (or otherwise) fu is impressive. Thanks!
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[-] elkrange | 1 points | Jul 16 2020 18:39:26
In tabular view, if you scroll down partway, there's a field in the left column called "Change History" that gives the link ("Complete list of historical versions of study NCT04374279 on ClinicalTrials.gov Archive Site").
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:43:54
Thanks for teaching me how to fish!
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[-] TrumpLyftAlles | 1 points | Jul 16 2020 18:52:19
Armed with the link to the old trial (thanks, elkrange), I also sent this:
Hi again, Dr. Marshall, I found the link to the original trial. The ivermectin treatment of 600mcg/kg was just right, IMO. If memory serves, another trial is looking at that dose, and another is looking at both 600mcg/kg and 1200mcg/kg (!!). Did you observe Central Nervous System effects? As you are very likely aware, this study: Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects
Looked for CNS toxicity and found none with the highest tested dose. Ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 microg/kg. I write this in the very faint hope that this is new information that might lead to your reversing your decision to drop the ivermectin arm of your trial.
- Name
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