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
et al., Indian Journal of Hematology and Blood Transfusion, doi:10.1007/s12288-022-01546-w, CTRI/2020/05/025068
, Single Dose of Ivermectin is not Useful in Patients with Hematological Disorders and COVID-19 Illness: A Phase.., Indian Journal of Hematology and Blood Transfusion, doi:10.1007/s12288-022-01546-w, CTRI/2020/05/025068
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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| 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.
Abstract: Indian J Hematol Blood Transfus
https://doi.org/10.1007/s12288-022-01546-w
ORIGINAL ARTICLE
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 George1 • Mahesh Moorthy5 • Uday Kulkarni1 • Sushil Selvarajan1 •
Priscilla Rupali2 • D. J. Christopher3 • T. Balamugesh3 • Winsley Rose4 •
Kavitha M. Lakshmi1 • Anup J. Devasia1 • N. A. Fouzia1 • Anu Korula1 •
Sharon Lionel1 • Aby Abraham1 • Vikram Mathews1
Received: 8 February 2022 / Accepted: 26 April 2022
Ó The Author(s), under exclusive licence to Indian Society of Hematology and Blood Transfusion 2022
Abstract 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 log10
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%;
Biju George and Mahesh Moorthy are primary authors.
& Biju George
biju@cmcvellore.ac.in
Mahesh Moorthy
maheshmoorthy@cmcvellore.ac.in
1
Department of Haematology, Christian Medical College,
Vellore, India
2
Department of Infectious Diseases, Christian Medical
College, Vellore, India
3
Department of Pulmonary Medicine, Christian Medical
College, Vellore, India
4
Department of Paediatric Infectious Diseases, Christian
Medical College, Vellore, India
5
Department of Clinical Virology, Christian Medical College,
Vellore, India
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.
Keywords Ivermectin COVID-19 Symptom
progression Survival
Late treatment
is less effective
is less effective
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