Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups
Scheim et al., OSF Preprints (Preprint) (meta analysis)
Scheim et al., Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of.., OSF Preprints (Preprint) (meta analysis)
Report on protocol violations in López-Medina et al.
Currently there are 95 ivermectin studies
and meta analysis shows:
Scheim et al., 11 Mar 2021, preprint, 3 authors.
Abstract: Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of
blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups
David E Scheim, a Jennifer A. Hibberd, b Juan J. Chamie-Quintero c
re: López-Medina et al., Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild
COVID-19: A Randomized Clinical Trial (JAMA, 2021; links to study paper and supplements are below).1
A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported
no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking
anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM
use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM
use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period,
with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of
contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A
labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for the
first 64 patients in the placebo group, easily distinguishable from bitter tasting IVM. Given widespread
availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVMcharacteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information
can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and
generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were
generally mild and transient.
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