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0 0.5 1 1.5 2+ Progression to serious.. -187% Improvement Relative Risk Recovery [data mismatch].. -18% Recovery [data misma.. (b) 6% Viral load, day 5 8% Viral load, day 14 2% Rocha et al. NCT04407507 Ivermectin RCT EARLY TREATMENT Favors ivermectin Favors control
Ivermectin compared with placebo in the clinical evolution of Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial
Rocha et al., Research Square, doi:10.21203/ (Preprint), NCT04407507 (history)
23 May 2022    Source   PDF   Share   Tweet
Authors did not respond to a request for the data.
Authors report 45.8% asymptomatic placebo patients on day 14, howevere there is no number of 26 patients that is 45.8%. Authors report 18% of ivermectin patients asymptomatic at day 5, however there is no number of 30 patients that is 18%.
The pre-registered outcome had no events. All other outcomes reported are post-hoc, added after completion of the study: []
External influences may have altered the paper. For example, 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 usually considered to be a positive result. This sentence may have been modified to be negative, while not fully updating the new sentence to be logical.
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.
risk of progression to serious adverse events, 186.7% higher, RR 2.87, p = 1.00, treatment 1 of 30 (3.3%), control 0 of 26 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of no recovery, 17.6% higher, RR 1.18, p = 0.59, treatment 19 of 30 (63.3%), control 14 of 26 (53.8%), day 14, numbers unclear due to data mismatch.
risk of no recovery, 5.8% lower, RR 0.94, p = 0.71, treatment 25 of 30 (83.3%), control 23 of 26 (88.5%), NNT 20, day 5, numbers unclear due to data mismatch.
viral load, 7.8% lower, relative load 0.92, p = 0.04, treatment mean 30.64 (±3.74) n=30, control mean 28.25 (±4.21) n=26, day 5.
viral load, 2.4% lower, relative load 0.98, p = 0.64, treatment mean 33.74 (±4.77) n=30, control mean 32.94 (±7.74) n=26, day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rocha et al., 23 May 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Mexico, preprint, 21 authors, dosage 12mg days 1-3, trial NCT04407507 (history).
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