Discussion Currently, as of December 14, 2020, the accumulating evidence demonstrating the safety and efficacy of Ivermectin(Iverheal 6) in COVID-19 strongly supports its immediate use on a risk/benefit calculation in the context of a pandemic. Regions of the world with widespread Ivermectin use have demonstrated a sizable reduction in case counts, hospitalizations, and fatality rates. This approach should be urgently considered in the presence of an escalating COVID-19 pandemic and as a bridge to vaccination.
A recent systematic review of eight RCTs by Australian researchers, published as a preprint, similarly concluded that Ivermectin(Iverheal) treatment led to a reduction in mortality, time to clinical recovery, the incidence of disease progression, and duration of hospital admission in patients across all stages of clinical severity (Kalfas et al., 2020).
Our current review includes a total of 6,612 patients from 27 controlled studies [16 of them were RCTs, 5 double-blinded, one single-blinded, (n= 2,503)]; 11 published in peer-reviewed journals including 3,900 patients. Pre-print publications have exploded during the COVID-19 pandemic.
Except for hydroxychloroquine and convalescent plasma that were widely adopted before the availability of any clinical data to support, almost all subsequent therapeutics were adopted after pre-print publication and prior to peer review. Examples include redeliver, corticosteroids, and monoclonal antibodies. An even more aggressive example of rapid adoption was the initiation of inoculation programs using novel mRNA vaccines prior to the review of either pre-print or peer-reviewed trials data by physicians ordering the inoculations for patients.11 In all such situations, both academia and governmental health care agencies relaxed their standard to rise to the needs dictated by the pandemic.
In the context of Ivermectin(Iverheal 12) long-standing safety record, low cost, and wide availability along with the consistent, reproducible, large magnitude findings on transmission rates, need for hospitalization, mortality, and population-wide control of COVID-19 case and fatality rates in areas with widespread Ivermectin(Iverheal) distribution, insisting on the remaining studies to pass peer review prior to widespread adoption appears to be imprudent and to deviate from the now established standard approach towards adoption of new therapeutics during the pandemic.
In fact, insisting on such a barrier to adoption would actually violate this new standard given that 12 of the 24 controlled trials have already been published in peer-reviewed journals. In regard to concerns over the validity of observational trial findings,
it must be recognized that in the case of Ivermectin(Iverheal); 1) half of the trials employed a randomized, controlled trial design (12 of the 24 reviewed above), and 2) that observational and randomized trial designs reach equivalent conclusions on average in nearly all diseases studied, as reported in a large Cochrane review of the topic from 2014 (Anglemyer et al., 2014).