Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH)
This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectine drug in high risk COVID-19 patients.
This study will compare Ivermectin treatment efficacy with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage 2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals within first 7 days of illness.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a multicenter, open-label, randomized controlled clinical trial involving COVID-19 designated hospitals in Malaysia. Patients are randomized at ratio of 1:1 to groups receiving ivermectin for 5 days plus standard-of-care versus standard-of-care only. Patients will be assigned to stratified randomized treatments based on a central, computer-generated randomization scheme coordinated by an independent third party. Based on national guidelines, all high risk COVID-19 patients will be admitted to hospitals, and allow discharge once criteria met |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial |
| Actual Study Start Date : | June 1, 2021 |
| Estimated Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | January 1, 2022 |
Outcome Measures
Primary Outcome Measures :
- Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]
The number of patients recruited who clinically deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
- Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]
The time duration for patients in the treatment arm to deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
Secondary Outcome Measures :
- Mortality [ Time Frame: Through study completion, an average of 28 days ]
- The number of died patients were evaluated in study and control groups. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
- Number of Participants with Complete Resolution of Symptoms by day 5 of Enrolment [ Time Frame: 5 days since time of recruitment ]
- The total numbers of patients with complete resolution of symptoms were evaluated in study and control groups. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
- Chest Radiograph Changes Pertaining to COVID-19 by Day 5 of Enrolment [ Time Frame: 5 days since time of recruitment ]
- Radiological Changes Pertaining to COVID-19 is recorded at day 1 of enrolment and compared with day 5 of enrolment. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
- Changes in Serum Absolute Lymphocyte Count [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
- For changes in Serum Absolute Lymphocyte counts (cell/mm3), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.
- Changes in Serum Absolute Neutrophil Counts [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
- For changes in Serum Absolute Neutrophil counts (cell/mm3), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.
- Changes in Serum C-Reative Protein (CRP) [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
- For changes in Serum C-Reative Protein (mg/L), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.
- Changes in Serum Creatinine [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
- For changes in Serum Creatinine (micro mol/L), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.
- Changes in Serum Alanine Aminotransferase (ALT) [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
- Numbers of Participants Admitted to the Intensive Care Unit [ Time Frame: Through study completion, an average of 28 days ]
- The number of patients admitted to the intensive care unit were evaluated in study and control groups
- Numbers of Participants who Require Mechanical Ventilation [ Time Frame: Through study completion, an average of 28 days ]
- The number of patients who require mechanical ventilation were evaluated in study and control groups
- The Length of Hospital Stay (in Calendar days) [ Time Frame: Through study completion, an average of 28 days ]
- The average number of hospitalisation required for both groups.
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: From the 6th day of study to the 28th day of study ]
- Adverse effects of ivermectin
- Eligibility Criteria
Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- RT-PCR confirmed COVID-19 cases
- Aged 50 years and above,with at least one co-morbidities*
- Within the first 7 days of illness (from symptom onset)
- Mild to moderate clinical severity
Exclusion Criteria:
- Asymptomatic stage 1 patients
- Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due to preexisting disease, eg. COAD or pulmonary fibrosis)
- Patients who need oxygen supplements
- Patients with concomitant bacterial, fungal, parasitic or other viral infections prior to enrollment.
- Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
- Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
- Pregnant or nursing women or women planning pregnancy.
- Female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of ivermectin administration to 7 days after the end of ivermectin administration
- Male patients whose partner cannot agree to use the contraception method described in (8) above
- Patients receiving chemotherapy
- Patients who received interferon or drugs with reported antiviral activity against COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment.
- Patients in whom this episode of infection is a recurrence or reinfection of COVID- 19.
- Patients who have previously received ivermectin.
- Patient receiving warfarin or any medications known to interact with ivermectin.
- Patients who are not able to provide written consent.
- Other patients judged ineligible by the principal investigator or sub-investigator.
Contacts and Locations
Information from the National Library of MedicineTo learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920942
Contacts
| Contact: STEVEN CL LIM, MRCP | 60133620081 | [email protected] | |
| Contact: Mohan D Pathmanathan, MD | 60129190794 | [email protected] |
| Malaysia | |
| Sultanah Aminah Hospital | Recruiting |
| Johor Bahru, Johor, Malaysia, 80000 | |
| Contact: Masliza Zaid, MRCP | |
| Sultanah Bahiyah Hospital | Recruiting |
| Alor Setar, Kadah, Malaysia, 05460 | |
| Contact: Lee L Low, MRCP | |
| Sultan Abdul Halim Hospital | Recruiting |
| Sungai Petani, Kedah, Malaysia, 08000 | |
| Contact: Noralfazita An@Amran, MRCP | |
| Hospital Raja Permaisuri Bainun, Ipoh | Recruiting |
| Ipoh, Perak, Malaysia, 30450 | |
| Contact: Hong B Ker, MRCP | |
| Taiping Hospital | Recruiting |
| Taiping, Perak, Malaysia, 34000 | |
| Contact: Wooi K Cheah, MRCP | |
| Tuanku Fauziah Hospital | Recruiting |
| Kangar, Perlis, Malaysia, 01000 | |
| Contact: Suhaila Ab Wahab, MRCP | |
| Pulau Pinang Hospital | Recruiting |
| George Town, Pulau Pinang, Malaysia, 10990 | |
| Contact: Ting S Chow, MRCP | |
| Lahad Datu Hospital | Recruiting |
| Tawau, Sabah, Malaysia, 911000 | |
| Contact: Song W Khoo, MRCP | |
| Sarawak General Hospital | Recruiting |
| Kuching, Sarawak, Malaysia, 93586 | |
| Contact: Han H Lim, MRCP | |
| Sungai Buloh Hospital | Recruiting |
| Shah Alam, Selangor, Malaysia, 47000 | |
| Contact: Kim H Tay, MRCP | |
| Kuala Lumpur Hospital | Recruiting |
| Kuala Lumpur, Malaysia, 50586 | |
| Contact: Khairil E Khalid, MRCP | |
| Melaka Hospital | Recruiting |
| Melaka, Malaysia, 754000 | |
Sponsors and Collaborators
Clinical Research Centre, Malaysia
Investigators
| Principal Investigator: | CHEE L LIM, MRCP | Ministry of Health, Malaysia |
| Responsible Party: | Clinical Research Centre, Malaysia |
| ClinicalTrials.gov Identifier: | NCT04920942 History of Changes |
| Other Study ID Numbers: | I-TECH21 |
| First Posted: | June 10, 2021 Key Record Dates |
| Last Update Posted: | June 21, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Clinical Research Centre, Malaysia:
| Ivermectin COVID-19 |
Additional relevant MeSH terms:
| Ivermectin Antiparasitic Agents Anti-Infective Agents |
See more here: clinicaltrials.gov
Header image: The Conversation
Please Donate Below To Support Our Ongoing Work To Defend The Scientific Method
PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company 
incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX.
Trackback from your site.
Brian James
| #
Oct 7, 2020 Trump Gets Natural COVID Treatments. What About Us?
https://youtu.be/d1v-dVfrsyo
Reply
FarthingtonMacMananus
| #
But what about when trump peddled vaccines, HCQ, Regeneron (from genetically modified “humanized” mice toxicity results, monoclonal garbage), remdesivir and such?
Guanold dump can get flushed, royally.
Reply
FarthingtonMacMananus
| #
Hey, like I said about a month ago. Ivermectin is what they want you to use, also HCQ, or remdesivir and vaccines.
See, all of that shit is unnecessary and has specific chlorine, electrical related function. I also said, they didn’t want you to use ivermectin THEN. They want you to use ivermectin now. That’s why the latest Pfizer attempt is quite similar to ivermectin.
But hey, you’re clever. You religiously believe covid is a thing that you need to attack with unnecessary pharmacuetical toxins that degenerate you, based on fraud, while you ignore essentials, physics, toxicology and other irrelevant mythical factors of legend.
Reply
FarthingtonMacMananus
| #
In the mean time, ignore say, proteolytic enzymes, magnesium, sulphur, antioxidation +1 gold edition.
Go get yourself some synthetic pharma shit known to be toxic, to address the phantom abstraction, instead.
Reply
FarthingtonMacMananus
| #
I joked about monoatomic gold there. And I didn’t even know that I did.
I’m gonna drink another beer and cry myself to sleep.
Reply
Maiasta
| #
Despite the fact that the battery of nutrients you mention is undoubtedly better than ivermectin, the latter will still come under attack, since it is an alternative to the “vaccine”, and the “vaccine”, let us not forget, is essentially the endgame.
Reply
FarthingtonMacMananus
| #
“… since it is an alternative to the “vaccine”, and the “vaccine”, let us not forget, is essentially the endgame.”
Well that’s the point I’m trying to make. But in exploitation maximization, you shouldn’t think of it merely as an alternative. It’s bonus murder kill stuff, for the glory of Stan! I mean, if someone was vaccinated and they get “breakthrough” whatever, maybe because they’re fucking retarded they’d think “Oh but this time I can trust pharma, because the OTHER side of the same coin says ivermectin and HCQ is for their wealth. And we know my health is dictated by their wealth.”
Just imagine like a pharmaceutical bouquet. So you take some some vaccine, but then you get sick, so you maybe use HCQ and ivermectin. Also, some of those rad new anti-covid vaccine drugs that are made by…the same sort of guys that make the vaccines. That’s interesting but inconsequential.
So anyway… maybe you get even sicker. And then you’re out of ideas, coz as far as you’re concerned, your bodily status can be completely categorized as requiring one of the few marketed drugs in the media which you religiously worship.
THAT’S WHEN THE FUN STARTS! Coz then you probably go to hospital, have some midazolam, heart destroying steroids, a ventilator and some other shit like cyanide to lessen the impact of those drugs and make you more comfortable.
https://bruciarecords.bandcamp.com/album/concealment
Reply
FarthingtonMacMananus
| #
Shit, I forgot you’d get remdesivir too. Extra bonus, coz that shit is fucking worthless but SUPER EXPENSIVE! So you’ll not be able to pay to exist anymore.
Reply
Maiasta
| #
I wouldn’t put ivermectin in the same category as remdesivir or midazolam.
Ivermectin has a good safety profile. Remdesivir, on the other hand, is a killer, and midazolam is used for the purpose of ‘medical’ euthanasia.
If ivermectin were truly dangerous, they would be forcing it upon us.
But, au contraire, France is confiscating ivermectin from its overseas territories in order to force the vaccine (in places that don’t want it):
https://yvymaraey.blogspot.com/2021/08/martinique-and-guadeloupe-ivermectin.html
Reply
FarthingtonMacMananus
| #
I would basically put it in the same category (unessential toxin avoiding fundamental causation).
BUT, I will concede that indeed, v:28 is far more effective.
FarthingtonMacMananus
| #
https://v28band.bandcamp.com/track/to-be-tuned
Sorry, forgot the advertising.
FarthingtonMacMananus
| #
My dad just told me something really important.
He said “Their menus are so programs”.
Doug
| #
another correction for you in your plethora of misinformation. Midazolam is primarily unsed in conscious sedation. That is what it’s used for 99.9% of the time. It’s primary use is not for euthanasia, never was, never will be, nor does it have any negative effect on the heart muscle. You are basically a liar.
FarthingtonMacMananus
| #
“That is what it’s used for 99.9% of the time. It’s primary use is not for euthanasia, never was, never will be, nor does it have any negative effect on the heart muscle. You are basically a liar.”
That’s super interesting, coz I didn’t shit about midazolam function. But thanks for the elaboration desperately trying to defend(?…I mean, you’re trolling them, right?).
Doug
| #
None of those drugs are even similar. You clearly don’t know what you are talking about. Millions of people are alive today becausae of “heart destroying steroids” They don’t destroy your heart by the way, that’s nonsense. Ivermectin is a very safe drug and Midazolam is a benzo. So according to you every classification of drug is dangerous and shouldn’t be used. People like you are dangerous and uninformed.
Thousdands and likely more are only alive today because they took Ivermectin or Plaquenil early on. You are just as dangerous, uninformed and as the rest of them. Your advice will also lead to deaths from anyone stupid enough to listen to you. In addition you have no actual training or credentials that make you credible to speak about this on any level. Googling a bunch of conspiracy theories and nonsense doesn’t give you the upper hand.
Incidentally as a nurse I can tell you that having been giving monoclonal antibodies other than remdesivir it seems anecdotally that they are very effective and most of my patient’s had profound turnarounds. What exactly is your experience in medicine? Just curious? Where did you take microbiology and A&P? What credentials do you hold that give you some special understanding about this the rest of us are lacking.
It’s people like you that cause all of us that don’t agree with the vaccine to look like we are fringe lunatics.
Reply
FarthingtonMacMananus
| #
No aspect of life ever needed pharma, hey.
Sorry to say.
Here’s a picture of your (oils, metals synthetic derivative biologically undermining social controller that wants to degenerate you for industrial profit with toxins) hero:
https://newspunch.com/rockefeller-big-pharma-natural-cures/
Reply
FarthingtonMacMananus
| #
“None of those drugs are even similar. You clearly don’t know what you are talking about. ”
Did I say they’re similar? I simply said, a bouquet of (unnecessary, toxic horseshit) pharmaceuticals.
Your grasping at what?
Reply
FarthingtonMacMananus
| #
I’d apologize for the grammar there. But considering the context, looks like I made the correct sort of mistake. Coz plural.
Doug
| #
appreciate the thoughts but many of the “drugs” you are deriding are made or were derived from natural sources that you are touting. You can’t have it both ways.
Reply
FarthingtonMacMananus
| #
“Derived” from.
So, which of these many drugs are “derived from” natural (necessary, more importantly) sources. And what is the extent of the derivation?
Like for instance, aspirin, acetyl-salicylate or whatever, I don’t remember, that’s “derived from” salycilic acid (excuse my typing). On the other hand, there’s for instance synthetic THC “derived from” natural THC.
Chloroquine (by bayer standards safe to sell now, but too toxic…in wartime), a derivation of natural quinine. But it’s a derivation in the sense of using, subverting function by adding unnecessary toxic shit.
And it was too toxic (except now), so they derived unnecessary hydroxychloroquine from that derived unnecessary product known as chloroquine.
So you certainly can’t have it both ways.
It’s either essential, natural, or it’s toxic pharmaceutical rockefeller industrial deathcult institute of medicine and such establised by peddling synthetics and derivatives of mining, oik and metals, for instance, while demonizing plants.
I believe a new sort of preternatural law is neecessary. When you derive something from any part of nature, nature is prior art. Go fuck yourself.
Reply
FarthingtonMacMananus
| #
By the way. That HCQ kinda hides some (ubi)quinine, quinone related sort of essential deficiencies, as well as vitamin D deficiency and shifts it with sort of exponential effect to other organs not so particularly associated with vitamin D issues. If you could believe such a thing.
Reply
PurplePeopleEater
| #
Hi Man Anus. Quaint name. If you are going to put “ington” as a suffix to a name it is necessary to further suffix “head” occasionally.
Example ; Farthingtonhead. You may get the hang of it.
That Doug is a terror and contrary “mary”.
How dare he correct and challenge for the safety , information, and credibility of readers.
Damn the torpedos.
Doug
| #
there isn’t a shred of science that any of those “nutrients” or electrolytes that are usually saturated and do little when you take them would have a positive effect once you actually get sick. Zero evidence of that. The drugs do work, there is irrefutible proof of that. People like this are dangrous and just as responsible for misleading people into dangerous territory as the people pushing the vaccine.
Reply
FarthingtonMacMananus
| #
So when potassium, magnesium, selenium, zinc, vitamin A, B, C, D, E, various antioxidants (relative to toxic inputs and such), melatonin, serotonin balance is fucked up….yeah you prescribe toxic shit.
I’m the most dangerous man that can conceivably exist, btw.
Reply
FarthingtonMacMananus
| #
Did you hear that, doug? Your scent’s been picked up by this black hound of vengeance that I casually associate with.
Reply
FarthingtonMacMananus
| #
Like, when you say “the drugs do work”.
Firstly, I take it you believe in physically fallacious horseshit like “viruses” while you ignore the OBVIOUS KNOWN PROVABLE CAUSATIVE associations of deficiencies and toxicities, imbalancies. Right?
Like, you think you have to attack “covid”, right?
Reply
FarthingtonMacMananus
| #
Remember when scurvy was considered a contagious thing…until it wasn’t, remember when Merck sold arsenic as a “skin medicine” regarding smallpox (and shit like arsenic being causative, btw)?
But I guess, if you just cut your finger, I can fix your pain there by decapitating you.
Reply
FarthingtonMacMananus
| #
Sick of this shit, sick of your lies, sick of your denial. I’ll let you burn.
Reply
FarthingtonMacMananus
| #
Here’s a random example.
Vitamin D, from sunlight, is like hormone, endocrine, immune genetic system regulator.
https://www.medicine.news/2021-09-17-study-confirms-sunlight-exposure-protect-against-covid.html
But did you know, the sunlight also has other associated function? Tryptophan, melatonin and serotonin balance. Good melatonin function, for instance, is necessary to sleep as well as I do and not like have to wonder if you’re going to get murdered tonight based on the damage you’ve caused. It also has significant antioxidation effects with respect to common toxins, AND EMF.
Reply
FarthingtonMacMananus
| #
“This method is known as Mendelian randomization. According to The BMJ, it “uses genetic variation to investigate the relations between modifiable risk factors and health outcomes in observational data.””
Alternatively, you could’ve have looked at every winter ever. Especially the catastophic winter awating, most greedily, the zombiedronerobosheepclone fodder in the northern hemisphere, within the next several months. I certainly can’t say I invented plants, physics or that I could even help you. BUT, I can promise you I won’t damage you like pharma does.
I like that Mendelian reference there, particularly considering my 46&2 sort of configuration (actually, I lie, it’s beyond that).
Listen closely to what he says.
https://mendelian.bandcamp.com/track/messengers-ii
War is safe.
Reply