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Single Dose of Ivermectin is not Useful in Patients with Hematological Disorders and COVID-19 Illness: A Phase II B Open Labelled Randomized Controlled Trial

George et al., Indian Journal of Hematology and Blood Transfusion, doi:10.1007/s12288-022-01546-w, CTRI/2020/05/025068
May 2022  
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Mortality, 24mg 30% Improvement Relative Risk Mortality, 12mg -3% Recovery time, 24mg 19% Recovery time, 12mg 6% Progression, 24mg 33% Progression, 12mg 18% Viral clearance, 24mg -33% Viral clearance, 12mg -18% Ivermectin  George et al.  LATE TREATMENT  RCT Is late treatment with ivermectin beneficial for COVID-19? RCT 112 patients in India (June 2020 - February 2021) Lower mortality (p=0.55) and faster recovery (p=0.37), not sig. c19ivm.org George et al., Indian J. Hematology an.., May 2022 Favorsivermectin Favorscontrol 0 0.5 1 1.5 2+
Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020, now with p < 0.00000000001 from 105 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 110 treatments. c19ivm.org
RCT with 35 single dose 24mg, 38 single dose 12mg, and 39 SOC hospitalized patients with hematological illnesses in India, showing no significant differences. Results were better for 24mg vs. 12mg for all symptomatic outcomes.
Viral clearance results do not follow the randomization with less than 50% of patients tested at day 7, and no adjusted results are provided. Results were obtained for only 43.8% of ivermectin patients and 56.4% of control patients at day 7 and may not be comparable due to the large difference in the percentage of patients tested. Lower test coverage in the ivermectin group is likely related to faster recovery. Ct 40 for E or S was used for viral clearance which may also have low relevance to infectious disease.
Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.
This is the 35th of 52 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000021.
This is the 84th of 105 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 774 quintillion).
risk of death, 30.4% lower, RR 0.70, p = 0.55, treatment 5 of 35 (14.3%), control 8 of 39 (20.5%), NNT 16, 24mg.
risk of death, 2.6% higher, RR 1.03, p = 1.00, treatment 8 of 38 (21.1%), control 8 of 39 (20.5%), 12mg.
recovery time, 18.7% lower, relative time 0.81, p = 0.37, treatment mean 4.82 (±4.35) n=35, control mean 5.93 (±5.93) n=39, 24mg.
recovery time, 6.2% lower, relative time 0.94, p = 0.78, treatment mean 5.56 (±5.42) n=38, control mean 5.93 (±5.93) n=39, 12mg.
risk of progression, 33.1% lower, RR 0.67, p = 0.41, treatment 6 of 35 (17.1%), control 10 of 39 (25.6%), NNT 12, 24mg.
risk of progression, 17.9% lower, RR 0.82, p = 0.79, treatment 8 of 38 (21.1%), control 10 of 39 (25.6%), NNT 22, 12mg.
risk of no viral clearance, 33.3% higher, RR 1.33, p = 0.50, treatment 10 of 15 (66.7%), control 11 of 22 (50.0%), subset of patients with a large difference between groups, day 7, 24mg.
risk of no viral clearance, 17.6% higher, RR 1.18, p = 0.75, treatment 10 of 17 (58.8%), control 11 of 22 (50.0%), subset of patients with a large difference between groups, day 7, 12mg.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
George et al., 27 May 2022, Randomized Controlled Trial, India, peer-reviewed, 15 authors, study period June 2020 - February 2021, dosage 24mg single dose, trial CTRI/2020/05/025068. Contact: biju@cmcvellore.ac.in, maheshmoorthy@cmcvellore.ac.in.
This PaperIvermectinAll
Single Dose of Ivermectin is not Useful in Patients with Hematological Disorders and COVID-19 Illness: A Phase II B Open Labelled Randomized Controlled Trial
Biju George, Mahesh Moorthy, Uday Kulkarni, Sushil Selvarajan, Priscilla Rupali, D J Christopher, T Balamugesh, Winsley Rose, Kavitha M Lakshmi, Anup J Devasia, N A Fouzia, Anu Korula, Sharon Lionel, Aby Abraham, Vikram Mathews
Indian Journal of Hematology and Blood Transfusion, doi:10.1007/s12288-022-01546-w
Repurposed drugs may reduce morbidity and mortality in patients with hematological disorders who develop COVID-19 illness. 112 patients with predominantly hematological illnesses were randomized to receive standard of care, ivermectin 12 mg [Iv 12] or 24 mg [Iv24] for asymptomatic, mild, or moderate COVID 19 illness. Serial respiratory samples for rRT-PCR samples were sent on Day 3, 5 and 7. rRT-PCR negativity and C 2 log 10 reduction in viral loads on day 3, 5 and 7 were similar between the 3 treatment groups across all disease categories. Symptom progression occurred in 26 patients [21.6%] with no difference across 3 treatment groups. Twenty-two patients [18.3%] have expired while 98 [81.7%] survived. Survival rates were similar across treatment groups [controls-80.5%, Iv12-77.5%, Iv24-87.2% respectively]. Overall, poorer survival was seen with moderate illness compared to others [51.6% vs 92.1%; p = 0.000] and was the only significant risk factor identified on multivariate analysis. In this Phase II randomised trial, single dose of 12 or 24 mg of ivermectin did not reduce viral loads, prevent symptom progression, or reduce mortality in patients with predominantly haematological illnesses who develop mild to moderate COVID 19 illness.
Author Contributions BG, UK designed the study, interpreted the data and drafted the paper. MM designed the study, acquired of laboratory data and drafted the paper. KML analysed the data, provided critical revision of the paper and approved the final version. SS, PR, DJC, BT, WR, AJD, FNA, AK, SL, AA and VM helped in acquiring the clinical data, interpretation of data and revising the manuscript critically. All authors have approved the final submitted version of the manuscript. Declarations Conflict of interest No conflicts of interest to declare for any of the authors.
References
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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