Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial
Niaee et al.,
Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center..,
Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.318304 (date from earlier preprint)
82% lower mortality with ivermectin. RCT with 180 hospitalized patients showing reduced mortality and hospital stay with ivermectin, with a wide margin of safety. All patients received SOC including low dose HCQ. Analysis suggests randomization failure
[]. This study was reported as pending retraction, however the journal has indicated that this is incorrect and no retraction is pending.
This study is excluded in the after exclusion results of meta
analysis:
analysis suggests randomization failure.
risk of death, 81.8% lower, RR 0.18, p = 0.001, treatment 4 of 120 (3.3%), control 11 of 60 (18.3%), NNT 6.7, All IVM vs. all control, primary outcome.
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risk of death, 94.3% lower, RR 0.06, p = 0.01, treatment 0 of 30 (0.0%), control 11 of 60 (18.3%), NNT 5.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), IVM single dose 200mcg/kg vs. all control.
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risk of death, 45.5% lower, RR 0.55, p = 0.37, treatment 3 of 30 (10.0%), control 11 of 60 (18.3%), NNT 12, IVM three dose 200mcg/kg vs. all control.
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risk of death, 94.3% lower, RR 0.06, p = 0.01, treatment 0 of 30 (0.0%), control 11 of 60 (18.3%), NNT 5.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), IVM single dose 400mcg/kg vs. all control.
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risk of death, 81.8% lower, RR 0.18, p = 0.06, treatment 1 of 30 (3.3%), control 11 of 60 (18.3%), NNT 6.7, IVM three dose 400/200/200mcg/kg vs. all control.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Niaee et al., 24 Nov 2020, Double Blind Randomized Controlled Trial, Iran, peer-reviewed, mean age 56.0, 14 authors, dosage 400μg/kg single dose, dose varies in different groups.
Abstract: [
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Asian Pacific Journal of Tropical Medicine 2021; 14(6): 266-273
apjtm.org
Original Article
Asian Pacific Journal of Tropical Medicine
doi: 10.4103/1995-7645.318304
Impact Factor: 1.94
Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A
randomized multi-center clinical trial
Morteza Shakhsi Niaee1, Peyman Namdar2, Abbas Allami3, Leila Zolghadr4, Amir Javadi5, Amin Karampour3,
Mehran Varnaseri6, Behzad Bijani7, Fatemeh Cheraghi1, Yazdan Naderi8, Fatemeh Amini9, Masoumeh Karamyan6,
Mohammad Jafar YadYad6, Ramin Jamshidian6, Nematollah Gheibi8
Sciences and Technology Park, Qazvin, Iran
1
Department of Surgery, Qazvin University of Medical Sciences, Qazvin, Iran
2
Department of Infectious Diseases, Clinical Research Development Unit, BouAliSina Hospital, Qazvin University of Medical Sciences, Qazvin, Iran
3
Department of Chemistry, Imam Khomeini International University Qazvin, Iran
4
Department of Social Sciences School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran
5
Infectious and Tropical Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
6
Department of Infectious Diseases, Qazvin University of Medical Sciences, Qazvin, Iran
7
Cellular and Molecular Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences,
Qazvin, Iran
8
Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
9
ABSTRACT
Objective: To evaluate different doses of ivermectin in adult patients
with mild COVID-19 and to evaluate the effect of ivermectin on
mortality and clinical consequences.
Methods: A randomized, double-blind, placebo-controlled,
multicenter clinical trial was performed at five hospitals. A total
of 180 mild hospitalized patients with COVID-19 confirmed by
PCR or chest image tests were enrolled and allocated to six arms
including hydroxychloroquine 200 mg twice per day, placebo
plus hydroxychloroquine 200 mg twice per day, single dose
ivermectin (200 µg/kg), three low interval doses of ivermectin
(200, 200, 200 µg/kg), single dose ivermectin (400 µg/kg), and
three high interval doses of ivermectin (400, 200, 200 µg/kg).
The primary endpoint of this trial was all-cause of mortality or
clinical recovery. The radiographic findings, hospitalization and
low O2 saturation duration, and hematological variables of blood
samples were analyzed.
Results: A total of 16.7% (5/30) and 20.0% (6/30) patients died
in arms treated with hydroxychloroquine 200 mg twice per day
and placebo plus hydroxychloroquine 200 mg twice per day,
respectively, and a reduction in mortality rate in patients
receiving ivermectin treatment to 0%, 10%, 0% and 3.3% for
arms 1-4 were observed. Risk of mortality was also decreased
about 15% in the ivermectin treated arms.
Conclusions: Ivermectin as an adjunct reduces the rate of mortality,
time of low O2 saturation, and duration of hospitalization in adult
COVID-19 patients. The improvement of other clinical parameters
shows that ivermectin, with a wide margin of safety, had a high
therapeutic effect on COVID-19.
KEYWORDS: SARS-COV-2; Ivermectin; Randomized controlled
trial; Dose-respond relationship
Late treatment
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