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0 0.5 1 1.5 2+ Mortality -4% Improvement Relative Risk Deterioration of 2 or more.. 41% Escalation of care 15% Fever during study 18% Recovery 36% primary Recovery time 31% primary Ivermectin  Abbas et al.  EARLY TREATMENT  DB RCT Is early treatment with ivermectin beneficial for COVID-19? Double-blind RCT 202 patients in China (May - August 2021) Improved recovery with ivermectin (p=0.037) Abbas et al., Indian J. Pharmaceutical.., Dec 2021 Favors ivermectin Favors control

The Effect of Ivermectin on Reducing Viral Symptoms in Patients with Mild COVID-19

Abbas et al., Indian Journal of Pharmaceutical Sciences, doi:10.36468/pharmaceutical-sciences.spl.416
Dec 2021  
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RCT 99 ivermectin and 103 control low risk patients in China, up to 7 days from symptom onset, showing statistically significant improvement in recovery with treatment, and non-statistically significant improvements in recovery time and deterioration.
Authors selectively omitted the p-value for recovery which shows statistical significance. Very little information on the patients is provided (only age, gender, and insurance status). The table, text, and abstract show three different versions of recovery numbers. The table and abstract show two different versions of recovery time. The abstract contains a hazard ratio that is not in the text, and no statistical methods are reported. Given the selective omission of the statistically significant recovery p-value, three different sets of numbers for that outcome, and other inconsistencies, the data in this study does not appear to be very reliable. Patients >50 were excluded.
Authors administered ivermectin on an empty stomach. Ivermectin is a lipophilic drug with low aqueous solubility and is better absorbed when given with food, especially high-fat meals. Administration with a high-fat meal can significantly increase plasma and tissue concentrations (~2.5x plasma concentration in Guzzo) and reduce time to onset of action. Standard practice for systemic use of ivermectin is administration with food (for intestinal parasitic infections, systemic distribution may not be required). Specifying fasted administration may avoid or delay the attainment of therapeutic concentrations and raises concerns about possible investigator bias.
This is the 32nd of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.
This is the 75th of 99 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion). This study is excluded in the after exclusion results of meta analysis: very minimal patient information, three different results for the recovery outcome, selective omission of the statistically significant recovery p-value, and other inconsistencies.
risk of death, 4.0% higher, RR 1.04, p = 1.00, treatment 1 of 99 (1.0%), control 1 of 103 (1.0%).
deterioration of 2 or more points, 40.5% lower, RR 0.59, p = 0.54, treatment 4 of 99 (4.0%), control 7 of 103 (6.8%), NNT 36.
escalation of care, 14.9% lower, RR 0.85, p = 0.82, treatment 9 of 99 (9.1%), control 11 of 103 (10.7%), NNT 63.
fever during study, 17.9% lower, RR 0.82, p = 0.58, treatment 15 of 99 (15.2%), control 19 of 103 (18.4%), NNT 30.
risk of no recovery, 35.6% lower, RR 0.64, p = 0.04, treatment 26 of 99 (26.3%), control 42 of 103 (40.8%), NNT 6.9, primary outcome.
recovery time, 30.8% lower, relative time 0.69, p = 0.08, treatment 99, control 103, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Abbas et al., 31 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, 3 authors, study period May 2021 - August 2021, dosage 300μg/kg days 1-5.
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The Effect of Ivermectin on Reducing Viral Symptoms in Patients with Mild COVID-19
K U Abbas, S Muhammad, S F Ding
Ivermectin is widely prescribed as a potential treatment for coronavirus disease 2019, despite uncertainty about its clinical benefit. To determine whether ivermectin is an efficacious treatment for mild coronavirus disease 2019 is the objective of the study. A total of 476 adult patients with mild symptoms for 7 d or fewer in Jinan, China, were enrolled and followed up. Patients were randomly selected to receive ivermectin, 300 μg/ kg body weight per day for 5 d or placebo. The median time to resolution of symptoms was 10 d (interquartile range, 9-13) in the ivermectin group whereas it was 12 d (interquartile range, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95 % confidence interval, 0.87 to 1.32]; p=0.53 by log-rank test). By d 21, 82 % in the ivermectin group and 79 % in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 104 patients (52 %) who received ivermectin and 111 patients (56 %) who received placebo. The most serious adverse event was multiorgan failure. Among adults with mild coronavirus disease 2019, a 5 d course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild coronavirus disease 2019.
Conflict of interests: The authors declared no conflict of interest.
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