Update: I will cover the I-TECH study published on 2/18/22 on Ivermectin in COVID-19 Patients soon. The link to the article (but not my thoughts just yet) is down below in the citations. I am on service this weekend and don’t have time to tackle it appropriately. Spoiler alert: as much as this is a well conducted randomized controlled trial looking at Ivermectin in COVID-19 patients, I have to state that they were looking at the wrong patient population. This is my opinion. Others will differ. But, you can’t look for clinical deterioration in patients who have a median age of 37. Both you and I know quite well, given that we have been taking care of these patients for over a year, that 37-year-old patients who have a BMI less than 30 generally do extremely well with COVID-19 and recover. This is why I always encourage you to read the article for yourself and not trust the headlines nor what I state.
The conclusions to this clinical trial state that “among adults with mild COVID-19, a five day course of ivermectin, compared to placebo, did not significantly improve the time to resolution of symptoms”. At the end of the day, but you and I know that we don’t really care about the resolution of symptoms. What we care about is avoiding people ending up in the hospital and avoiding death. This study did not look at that whatsoever. So you can’t state in good faith that this trial answers that question. At the time of randomization, 61.5% of patients in the ivermectin group were not hospitalized and they also had no limitation of their activities. Do I need to clarify this anymore? These patients were able to continue living their life without any issues whatsoever.
This is another one of those clinical trials that I wish was positive but unfortunately it is a negative trial. Based on this data that were published on 4 March of 2021, it seems as if ivermectin does not help with the time to resolution of symptoms in patients with mild COVID-19. I have covered the utilization and concepts behind using ivermectin in COVID-19 on several occasions before including posts back in April as well as May 2020. Since then, there have been numerous studies but, to be completely honest, they haven’t been of high quality. Over REBEL-EM, my buddy Salim Rezaie has created a compendium of the numerous studies looking at ivermectin and critiquing them appropriately. I recommend that you check out that post for further details as to why one should not rely their clinical practice based on these multiple studies.
I would like to tip my hat to the authors and researchers who are over in Colombia for coming up with the study. What they did was randomize patients to receive either ivermectin at 300 µg per kilogram of body weight orally per day for five days versus a placebo in a double blind style. The primary outcome was to determine if ivermectin help to resolve symptoms faster than placebo in a 21 day follow up period.
The first question I always ask myself whenever I read one of the studies is what is the patient population in whom this was a minister to. Here, it seems as if it was a combined outpatient as well as inpatient study. Although, the inpatient population were those who were not on high flow nasal cannula, non-invasive ventilation nor mechanical ventilation.
A bit of good news overall was discovered while conducting the study because the primary outcome was grossly defined as patient is worsening based on a scale. They actually found, however, that there was an insufficient amount of patient worsening in both the control and experimental group to reach this primary outcome. This meant that they had to change their original primary outcome. They also had some other errors listed which you should read for yourself.
I am not going to waste your time any further looking into the study. I’m actually surprised that JAMA went ahead and published this. I am also surprised at the amount of people who want this therapy to fail. We absolutely have no idea whether it works or it doesn’t work. There is no denying that. There’s no robust randomized controlled trial looking at ivermectin and showing beneficial results that are practice changing. That being said this is not a negative trial of ivermectin. If this trial would have been conducted in patients, like many other trials have done in the past, where they look at people who are greater than or equal to 65 years of age with risk factors and comorbidities then we could have a more valid conversation.
Check out my first post on Ivermectin HERE from 4/5/2020
Check out my second post on Ivermectin HERE from 5/2/2020
Citations for Ivermectin in COVID:
López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071. PMID: 33662102; PMCID: PMC7934083.
Link to Article and FULL FREE PDF
Study Published in JAMA Internal Medicine on 2/18/22
Lim SCL, Hor CP, Tay KH, Mat Jelani A, Tan WH, Ker HB, Chow TS, Zaid M, Cheah WK, Lim HH, Khalid KE, Cheng JT, Mohd Unit H, An N, Nasruddin AB, Low LL, Khoo SWR, Loh JH, Zaidan NZ, Ab Wahab S, Song LH, Koh HM, King TL, Lai NM, Chidambaram SK, Peariasamy KM; I-TECH Study Group. Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial. JAMA Intern Med. 2022 Feb 18. doi: 10.1001/jamainternmed.2022.0189. Epub ahead of print. PMID: 35179551.
Link to Article and FULL FREE PDF
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