The I-TECH ivermectin trial just concluded, and the results summary show that ivermectin FAILED to prevent severe COVID-19!
Here is what you need to know…
I-TECH Study : Multi-Centre Ivermectin Trial Vs. COVID-19
On 6 June 2021, the Malaysia Ministry of Health started an Ivermectin trial for high-risk COVID-19 patients called the I-TECH (Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients) Study.
The I-TECH Study was a multi-centre open-label randomised controlled trial approved by the Medical Research and Ethics Committee (MREC), and registered in the Clinical Trials database as NCT04920942.
The trial was conducted by the Institute for Clinical Research (ICR), together with infectious disease physicians and clinicians at 20 government hospitals and the MAEPS 2.0 Quarantine and COVID-19 Treatment Centre.
500 patients were recruited for the I-TECH study, with four excluded for not meeting the study criteria and six withdrawing after expressing concerns about ivermectin’s side effects.
- patients who were 50 years and above, with co-morbidities were selected
- patients had to be hospitalised, with Stage 2 / 3 (mild to moderate) COVID-19
- patients were randomised at a 1:1 ratio to :
a) IVM group receiving ivermectin + standard of care
b) SOC group receiving only standard of care
- IVM group patients received 2X the standard dose of ivermectin (0.4 mg/kg/day) for 5 days
The last patient was recruited on 9 October 2021, and the follow-up ended on 25 October 2021.
I-TECH Study Results : Does Ivermectin Work Against COVID-19?
Here is a summary of the I-TECH study results that were announced by the Malaysia Ministry of Health :
- Ivermectin did not prevent patients from progressing to severe COVID-19
- Ivermectin did not delay the progression to severe COVID-19
- Patients on ivermectin complained of 3X more adverse events
- The most common ivermectin side effect was diarrhoea
- There was no difference between the two groups in terms of ICU admission, mechanical ventilation, symptom recovery, blood parameters and chest x-ray resolution.
- The rate of full symptom recovery by Day 5 was very similar between the two groups
- There was a trend of reduced 28-day mortality, but it was not statistically significant (p=0.09).
Independent analysis was not able to determine if mortality was indeed reduced, due to the few deaths in this study (13 out of 490).
For those who prefer their results in tabular form, I summarised their results in this table :
|Symptom Recovery by Day 5||Very similar||Not significant (p=0.77)|
|Progress to Severe COVID-19||IVM : 21.2%
SOC : 17.3%
|SOC : -3.9 points
Not significant (p=0.30)
|Time to Severe COVID-19||IVM : 3 days (±2.3)
SOC : 2.9 days (±1.8)
|IVM : +0.1 day
Not significant (p=0.68)
|ICU Admission||NA||Not significant|
|Mechanical Ventilation||NA||Not significant|
|Symptom Recovery||NA||Not significant|
|Blood Parameters||NA||Not significant|
|Chest X-Ray Resolution||NA||Not significant|
|Adverse Events||3X more in IVM group||Significant|
|Mortality||NA||Not significant (p=0.09)|
As a result of ivermectin’s lack of effect on the 490 patients in the I-TECH study, the Malaysia Ministry of Health sites that :
- The outcome of the I-TECH study shows that ivermectin does not reduce risk of severe illness from COVID-19
- Ivermectin cannot be recommended for inclusion in current COVID-19 treatment guidelines
- The MOH will continue with prior advice that ivermectin only be used within clinical trials settings with monitoring.
The Ministry of Health also pointed out the I-TECH study findings are supported by other recent large ivermectin studies like IVERCOR-COVID19 from Argentina and the TOGETHER trial from Brazil.
The I-TECH team will submit their data for publication in a peer-reviewed journal to help provide additional research information for ivermectin studies, including meta-analyses.
Finally, the Malaysia Ministry of Health cautioned medical practitioners NOT to recommend ivermectin, including sharing illegal advertising or sale of ivermectin for the treatment of COVID-19.
I should point out that individuals or companies that sell illegal ivermectin can face fines of up to RM100,000 and/or 5 years of prison.
How Do I-TECH Study Results Compare With Other Ivermectin Studies?
The Malaysia Director-General of Health, Dr. Noor Hisham Abdullah also shared an updated meta-analysis of ivermectin trials with the new I-TECH study results, but removing three fraudulent studies – Elgazzar, Okomus and Niaee.
Results towards the left suggest a clinical benefit for ivermectin. In this case, Dr. Noor Hisham used the study’s most promising result – post-study mortality, but even that did not reach clinical significant (p<0.05)
You can also see the results of the TOGETHER trial from Brazil, and IVERCOR-COVID19 (Vallejos) trial that Dr. Noor Hisham mentioned just above the I-TECH results.
Taken in totality, the updated meta-analysis show that the clinical effect of ivermectin on COVID-19 patients is NOT SIGNIFICANT enough to warrant being used as a treatment.
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