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0 0.5 1 1.5 2+ Mortality 69% Improvement Relative Risk Mortality (b) 75% Ventilation 59% ICU admission 22% Progression 31% Progression (b) -25% primary Hospitalization time -5% Recovery -2% Lim et al. NCT04920942 I-TECH Ivermectin RCT LATE Favors ivermectin Favors control
Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial
Lim et al., JAMA, doi:10.1001/jamainternmed.2022.0189 (data 11/3/21), I-TECH, NCT04920942 (history)
3 Nov 2021    Source   PDF   Share   Tweet
RCT 490 late stage (>65% lung change chest radiography at baseline) hospitalized patients in Malaysia, showing no significant differences.
Mortality was 1.2% for ivermectin vs. 4% for control. If the same event rates continue, the trial would need to add ~13% more patients to reach statistical significance.
i.e., by continuing the trial for ~2 weeks, there is a reasonable chance of the result being a statistically significant ~69% reduction in mortality, which would equate to ~4 million lives saved if adopted at the start of the pandemic.
The mortality reduction is consistent with the results from all trials to date. While not reaching the significance threshold with the specified test, Bayesian analysis shows a 97% probability that ivermectin reduces mortality [].
Authors describe the mortality results as "similar" and they are not mentioned in the visual abstract or the conclusion, suggesting substantial investigator bias with a preference for a null result.
The primary outcome is based on SpO2 <95%, however baseline SpO2 is not provided. This outcome is of limited use in evaluating treatment because it occurred before the end of treatment for > ~80% of patients. The trial was open label and the primary outcome is subject to investigator bias - clinicians could easily bias the results by altering how they monitor SpO2, how precisely they enforced the threshold, or other aspects of SOC such as propensity to use prone positioning. Authors indicate the 95% value is from clinical stage 4, however the Malaysian government defines 94% as the threshold for stage 4 [], as per the NIH definition []. Using death/IMV/NIV/high flow for severe (as per WHO) also shows more favorable results [].
The mortality rate among all patients is too low to detect a 69% benefit with statistical significance, however the primary outcome gives us a subset of patients with severe cases that had progressed to SpO2 <95% shortly after randomization (and mostly before treatment ended). This result is statistically significant. For more discussion see: [ (B), (C)].
The trial started May 31, 2021 and outcomes were changed in the trial record on June 16, 2021 []. Previously the only clinical outcomes listed (under secondary outcomes) were mortality and clinical response, both at 28 days. Clinical response at 28 days would be more informative than complete recovery at day 5 as reported.
Contact information was deleted in the trial record on November 3, 2021 [ (B)].
Data sharing: authors report that the data is available, send requests to: NCT04920942 (history).
risk of death, 69.0% lower, RR 0.31, p = 0.09, treatment 3 of 241 (1.2%), control 10 of 249 (4.0%), NNT 36.
risk of death, 75.2% lower, RR 0.25, p = 0.02, treatment 3 of 52 (5.8%), control 10 of 43 (23.3%), NNT 5.7, among patients progressing to severe cases (mostly before treatment ended).
risk of mechanical ventilation, 59.0% lower, RR 0.41, p = 0.17, treatment 4 of 241 (1.7%), control 10 of 249 (4.0%), NNT 42.
risk of ICU admission, 22.0% lower, RR 0.78, p = 0.79, treatment 6 of 241 (2.5%), control 8 of 249 (3.2%), NNT 138.
risk of progression, 31.1% lower, RR 0.69, p = 0.29, treatment 14 of 241 (5.8%), control 21 of 249 (8.4%), NNT 38, death/IMV/NIV/high flow (WHO severe cases).
risk of progression, 25.0% higher, RR 1.25, p = 0.25, treatment 52 of 241 (21.6%), control 43 of 249 (17.3%), primary outcome.
hospitalization time, 5.5% higher, relative time 1.05, p = 0.38, treatment 241, control 249.
risk of no recovery, 2.5% higher, RR 1.02, p = 0.86, treatment 116 of 241 (48.1%), control 116 of 247 (47.0%), day 5.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lim et al., 3 Nov 2021, Randomized Controlled Trial, Malaysia, peer-reviewed, 26 authors, study period 31 May, 2021 - 9 October, 2021, average treatment delay 5.1 days, dosage 400μg/kg days 1-5, trial NCT04920942 (history) (I-TECH).
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