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0 0.5 1 1.5 2+ Hospitalization -211% Improvement Relative Risk Hospitalization (b) -610% Change in viral load 20% primary Change in viral load (b) 31% primary Buonfrate et al. NCT04438850 Ivermectin RCT EARLY Favors ivermectin Favors control
Buonfrate, 61 patient ivermectin early treatment RCT: 20% improved viral clearance [p=0.59]
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High dose ivermectin for the early treatment of COVID-19 (COVER study): a randomised, double-blind, multicentre, phase II, dose-finding, proof of concept trial
Buonfrate et al., International Journal of Antimicrobial Agents, doi:10.1016/j.ijantimicag.2021.106516 (date from earlier preprint), COVER, NCT04438850 (history)
6 Sep 2021    Source   PDF   Share   Tweet
Early terminated 89 patient RCT with 29 high dose and 32 very high dose ivermectin patients, showing dose dependent viral load reduction, although not reaching statistical significance due to early termination. Since most patients have low viral load at day 7, there is little room for improvement with a treatment at day 7. Intermediate results may show significantly greater improvement, but are not provided. Authors note that ivermectin remained safe even at the very high dose used, although tolerability was reduced. Adherence was very low in the very high dose arm (~60%).
The paper reports 4 SAEs, all resolved, with 3 patients hospitalized in the very high dose ivermectin arm, 1 in the high dose arm, and 0 in the control arm. However, the supplementary data is contradictory, showing 2 grade 3 events in both ivermectin arms (2 infections and infestations, and 2 COVID-19 pneumonia). While this result is not statistically significant, it may be in part due to randomization failure because three times as many patients were randomized in a hospital setting in the ivermectin arms (12/58) compared to the placebo arm (2/29), as shown in supplemental table 2, suggesting higher baseline severity in the ivermectin arms. The very high dose ivermectin arm also had more male patients (73% vs. 45%), higher median weight (79 vs. 70kg), and higher baseline cough (56% vs 42%), pyrexia (56% vs 33%), and anosmia (33% vs 17%) as per supplemental table 2.
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risk of hospitalization, 210.7% higher, RR 3.11, p = 0.47, treatment 1 of 28 (3.6%), control 0 of 31 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), arm B.
risk of hospitalization, 610.0% higher, RR 7.10, p = 0.11, treatment 3 of 30 (10.0%), control 0 of 31 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), arm C, very high dose, poorly tolerated with low compliance.
relative change in viral load, RR 0.80, p = 0.59, treatment mean 2.5 (±2.2) n=28, control mean 2.0 (±4.4) n=29, day 7, arm B, primary outcome.
relative change in viral load, RR 0.69, p = 0.07, treatment mean 2.9 (±1.6) n=30, control mean 2.0 (±2.1) n=29, day 7, arm C, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
This study is excluded in the after exclusion results of meta analysis: significant unadjusted group differences, with 3 times as many patients in the ivermectin arms having the baseline visit in a hospital setting, and arm C having large differences in baseline gender, weight, cough, pyrexia, and anosmia, excessive dose for arm C.
Buonfrate et al., 6 Sep 2021, Double Blind Randomized Controlled Trial, Italy, peer-reviewed, 18 authors, average treatment delay 4.0 days, dosage 1200μg/kg days 1-5, arm B 600µg/kg, arm C 1200µg/kg, trial NCT04438850 (history) (COVER).
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