Meta-Analysis of 38 Studies Reveals Potential of Ivermectin as Adjuvant Therapy for Mild-to-Moderate COVID-19 Patients & Reduced Risk of Mortality

Meta-Analysis of 38 Studies Reveals Potential of Ivermectin as Adjuvant Therapy for Mild-to-Moderate COVID-19 Patients & a Reduced Risk of Mortality

A group of researchers from prominent institutions, including Mayo Clinic, Rochester and Government Medical College in India, recently conducted a comprehensive meta-analysis evaluating the benefits and possible risks associated with the use of ivermectin as a treatment option targeting SARS-CoV-2, the virus behind COVID-19. The authors recently shared the results with medRxiv. Although not peer reviewed nor published as of yet, the findings were of interest and are now available on the preprint server medRxiv. Their efforts are premised on the challenge that despite over a year of intensive R&D spend in the billions of dollars, there is still no effective therapy for the COVID-19 virus. The authors acknowledge that ivermectin has demonstrated positive results in several observational studies and after a review of 38 studies covering 15,002 patients, the research team came to the conclusion that their analysis points to ivermectin as a possibly effective adjuvant therapy in helping to reduce mortality—only in those patients with mild-to-moderate clinical presentation of COVID-19 based on high certainty of evidence from RCTs subgroup analysis. However, certainty of evidence was very low in observational studies. Decreased need for ICU admissions and mechanical ventilation were observed, however the findings were not statistically significant. An analysis of adverse events was inconclusive. Due to high heterogeneity in analysis and low to moderate level of certainty of evidence, they suggest use of Ivermectin in COVID-19 patients should depend on bedside clinician’s judgement.  

Led by corresponding author Vikas Bansal, MBBS, MPH, Assistant Professor of Medicine, Division of Pulmonary Medicine and Critical Care at Mayo Clinic (Rochester, MN), the team reviewed a total of 38 clinical trials involving 15,002 patients. Apparently, ivermectin influenced a lower mortality rate: those in the ivermectin arms of study experienced lower mortality as compared to the non-ivermectin arms (OR 0.39, 95% CI 0.22-0.70; I2 84=81%). A subgroup analysis of 12 clinical trials based on severity-based data revealed that the ivermectin arm showed morality benefit (OR 0.33, 95% CK 0.15-0.72; 12 85 = 53%) as well as benefit in the mild/moderate subgroup (OR 0.10, 95% CI 0.03-0.33; I2 86 =0%).

Moreover, the team uncovered that the benefit of ivermectin in lowering the need for ICU admission (OR 0.48, 95% CI 0.17-1.37; I2 87 =59%) as well as mechanical ventilation (OR 0.64, 95% CI 0.40-1.04; I2 88 =17%), however, it was not  statistically significant.

They concluded that this meta-analysis revealed that Ivermectin may in fact represent an effective adjuvant therapy in reducing mortality, especially in those patients classified in the mild-to-moderate stage. They proposed that there is a need of pragmatic practice embedded platform trials to test Ivermectin and other re-purposed and novel therapies specifically in severe COVID-19 patients. TrialSite notes that in most places around the world, about 90% of the COVID-19 infections fall into this category.

TrialSite briefly spoke with corresponding author Vikas Bansal who shared that this was an investigator-initiated study as he and colleagues sought to better understand the efficacy of ivermectin given the pandemic and the fact that in countries like India, wide-spread vaccination may take longer and hence low cost therapies can be of great public health benefit.

Dr. Bansal shared with TrialSite that the team has submitted the manuscript to the ​​​​​​​Critical Care Medicine Journal, which is the premier peer-reviewed, scientific publication of Society of Critical Care Medicine’s official Journal for peer review and publishing.

Lead Research/Investigator

Vikas Bansal, MBBS, MPH, Assistant Professor of Medicine, Division of Pulmonary Medicine and Critical Care at Mayo Clinic, Rochester

Smruti Karale, MBBS, Department of Internal Medicine, Government Medical College-Kolhapur, Kolhapur, Maharashtra, India

Rahul Kashyap, MBBS, MBA, Assistant Professor of Anesthesiology, Department of Anesthesiology and Critical Care Medicine at Mayo Clinic, Rochester

Twitter handles

@VikasBa23474580, @Dr_SRKashyap, @romilsingh1892, @AyssTekin

Responses

  1. “benefit of ivermectin in lowering the need for ICU admission (OR 0.48, 95% CI 0.17-1.37; I2 87 =59%)”

    I have enough background to understand statistics and probability, but I am unfamilar with the notation at the end of statements like this. I get OR and CI, but what does “12 87 = 59%” mean?

  2. Guys, again, why don’t you include the link to the study??? Why are you not listening to your readers? People here in the comments have pointed out numerous times the lack of a link to the original paper in many of your recent stories. You go through so much trouble to research, interview, write up and publish a story, and you can’t make just a TINY little more effort to include the link in a short sentence at the end?
    Here, this is how you do it:
    “The referenced study: https://www.medrxiv.org/content/10.1101/2021.04.30.21256415v1

    1. Thanks for your comment – at times we are made privy to studies that have not yet been published – and this was the case here. Therefore no link can be provided at this time until the study has been published. “Although not peer reviewed nor published as of yet.”

  3. After over 12 months since the priginal Monash work and numerous small trials, how is it that we are still looking a meta data from the myriad small studies. Where are the 1000 plus subject, double blind placebo controlled study results? Or does no one think the funding is worth it. Get the proper studies done and publish the results and then we will know with certainty.

    1. The current studies are far more than adequate. dismissing their worth and demanding more delays for long term RCTs is unwarranted. And those RCT cost millions? Who will pay? Big Pharma and the national PHA they have co-opted and corrupted. Their studies will be designed to fail and to attck the efficacy of non-patentable, inexpensive therapeutics, such as ivermectin that has already gone through huge testing and trials to become licensed and approved by the USA FDA. Doctors are free to use it off label for covid or any other disease they think the benefits exceed the risks.