Small low-risk patient RCT with 30 low-dose ivermectin and 26 control patients, with no primary outcome events in either arm. Viral load was significantly better with ivermectin on day 5, while there was no significant difference on day 1 or day 14. There was no significant difference in combined symptoms, however authors include cough which was the most frequent symptom and may persist long after infection has been cleared. Ivermectin patients were 4 years older with a higher standard deviation, had higher prevalence of obesity, diabetes, hypertension, and cardiovascular disease, and lower prevalence of hepatic and kidney disease.
SOC included acetaminophen, which shows
27% [9‑47%] higher risk from
18 studies to date. The slow viral clearance seen may be in part due to acetaminophen use.
Authors conclude that "ivermectin is not effective to prevent progression to a severe state". This is false, there was no progression to severe in either group.
Authors report 92.9% of ivermectin patients compliant with the symptom diary, however there is no number of 30 patients that is 92.9%.
Authors report 45.8% asymptomatic placebo patients on day 14, howevere there is no number of 25 (exc. diary non-compliance) or 26 patients that is 45.8%.
Authors report 37% asymptomatic ivermectin patients on day 14, howevere there is no number of 28 (exc. diary non-compliance) patients that is 37%.
Authors report 28% viral- for ivermectin on day 14, however there is no number of 30 patients that is 28%.
Authors have not yet responded to a data query.
The pre-registered outcome had no events. All other outcomes reported are post-hoc, added after completion of the study:
[clinicaltrials.gov]External influences may have altered the paper. For example, in the preprint authors state:
"Taken together, these data do not show that ivermectin is effective in the treatment of COVID-19 by "accelerating" viral clearance in the first week, which may translate into a lower rate of complications." Elsewhere, authors note faster viral clearance at day 5, which is a positive result. This sentence may have been modified to be negative, while not fully updating the new sentence to be logical.
This study is excluded in the after exclusion results of meta
analysis:
data mismatch, no response from authors.
de la Rocha et al., 23 May 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Mexico, peer-reviewed, 21 authors, dosage 12mg days 1-3, trial
NCT04407507 (history).
Contact:
arieh.mercado@academicos.udg.mx (corresponding author).