Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
et al., International Journal of Sciences, 9:31-35, doi:10.18483/ijSci.2378, NCT04739410, Sep 2020
Ivermectin for COVID-19
4th treatment shown to reduce risk in
August 2020, now with p < 0.00000000001 from 106 studies, recognized in 24 countries.
No treatment is 100% effective. Protocols
combine treatments.
6,600+ studies for
220+ treatments. c19early.org
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Small RCT with 25 ivermectin and 25 control patients, not finding a significant difference in recovery at day 7.
This study has several major issues:
Failed/uncertain randomization - five of eleven baseline characteristics differ significantly between arms (cough, vomiting, diarrhea, loss of taste, anosmia), when ~0.5 would be expected by chance. The probability of this occurring through genuine randomization is ~0.0001, and the imbalance is patterned (controls loaded with GI symptoms, cases with sensory loss), indicating the randomization either failed or was not truly random.
Unadjusted confounding making the result uninterpretable - because the arms differ at baseline on exactly the symptoms that drive the "symptom-free" endpoint, and no covariate adjustment was performed, the headline comparison is close to meaningless. Different starting symptom profiles have different natural recovery trajectories.
Wrong percentage denominators throughout - within-group percentages in Tables 1 and 3 (and the narrative text) are calculated against the total sample (N=50) instead of the group size (N=25), e.g., 17 male cases shown as 34% rather than the correct 68%.
Retrospective trial registration: NCT04739410 (history) was registered February 2021, after the study finished (June 2020) and after publication (September 2020).
Contradictory case definition - Table 1 reports 100% dyspnea in both arms, but the inclusion criteria specify "mild" disease, and dyspnea typically categorizes a case as moderate-to-severe.
Non-reproducible primary p-value - the reported p = 0.500 for 16/25 vs 15/25 cannot be reproduced by any standard test (Fisher's exact ≈ 1.0).
Internal contradictions and transcription errors - the primary-outcome sentence labels both subgroups "asymptomatic"; the nausea total reads 26 when 6+10=16; mean age is reported three different ways (40.60, 41.84, 42).
Identical loss-of-taste and anosmia counts - both rows are exactly 15/5 across both arms for two distinct symptoms, suggesting a possible combined-item duplication.
Underpowered with conflicting methods - n=25/arm with no power calculation, and "convenient sampling" described alongside "computer-generated randomization."
This is the 5th of 54 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000004.
This is the 9th of 106 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001.
This study is excluded in the after exclusion results of meta-analysis:
multiple significant issues - pending author response.
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risk of no recovery at day 7, 10.0% lower, RR 0.90, p = 0.50, treatment 9 of 25 (36.0%), control 10 of 25 (40.0%), NNT 25, primary outcome.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Chachar et al., 30 Sep 2020, Randomized Controlled Trial, India, peer-reviewed, 6 authors, dosage 36mg, 12mg stat, 12mg after 12 hours, 12mg after 24 hours, trial NCT04739410 (history).
Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
International Journal of Sciences, doi:10.18483/ijsci.2378
Background:The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings: Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration of Study: From 1 st May, 2020 to 30 th June, 2020.Patients & Methods: Sample size and technique: Sample size was 50 patients; 25 patients were kept in control group and 25 patients were kept in experimental group. Results: There were total 50 patients, divided into two groups case and control group.The mean age of the participants was 40.60 ± 17 and out of those 31 (62%) were male and 19 (38%) were females. Cough was observed more in case group (p= 0.049). Fever, myalgias and dyspnea were the commonest symptoms in both the groups (p= 1.000). Diarrhea and vomiting were more common in control group (p=0.0001, p= 0.042 respectively). On follow up at day 7, patients were stratified as asymptomatic and symptomatic. Amongst the case group, out of 25 patients, 16(64%) patients were asymptomatic and rest of the 9(36%) patients was asymptomatic. In control group, out of 25 patients, 15(60%) patients were asymptomatic and rest of the 10(40%) patients was asymptomatic. p-value (0.500). Statistically there was no significant difference between case group who were given ivermectin along with symptomatic treatment and control group who were only given symptomatic treatment without ivermectin, being asymptomatic on day 7 at follow up. p-value (0.500
References
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Caly, Druce, Catton, Jans, Wagstaff, The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, Antiviral research, doi:10.1016/j.antiviral.2020.104787
Chowdhury, Shahbaz, Karim, Islam, Dan et al., A comparative observational study on Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients, doi:10.21203/rs.3.rs-38896/v1
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Rajter, Sherman, Fatteh, Vogel, Sacks et al., ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19, medRxiv, doi:10.26434/chemrxiv.11875446.v1
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Late treatment
is less effective
is less effective
