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Research Article
Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial
Nematollah Gheibi
Qazvin university of medical sciences
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
Background: It appears that ivermectin can potentially act against COVID-19 infection. Today, it is an urgent need to evaluate the efficacy and safety of ivermectin. The effect of ivermectin therapy on mild to severe COVID-19 patients was investigated.
Methods: A 45-days randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical trial was designed at five hospitals. A total number of 180 mild to severe hospitalized patients with confirmed PCR and chest image tests were enrolled. The radiographic findings, hospitalization and low O2 saturation duration, and clinical outcomes such as mortality and variables of blood samples were analyzed using standard statistical analyses in SPSS (V20).
Results: Average age of the participants was 56 years (45-67) and 50% were women. The primary and secondary results showed significant changes between day zero and day five of admission (∆ 0/5) in terms of ΔALC5/0, ΔPLT5/0, ΔESR5/0, ΔCRP5/0, duration of low O2 saturation, and duration of hospitalization (CI = 95% ). Risk of mortality was also decreased significantly in the study groups.
Conclusion: Ivermectin as an adjunct reduced the rate of mortality, low O2 duration, and duration of hospitalization in adult COVID 19 patients. The improvement of other clinical parameters showed that the ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.
Trial Registration: This trial was registered with the Iranian Registry of Clinical Trials website (registration ID IRCT20200408046987N1).
Keywords
SARS-CoV-2, Ivermectin, Randomized controlled trial, Dose-response relationship
Figure 1
Figure 2
Jean-Claude Ghaleb
commented on 25 November, 2020
There’s probably a mistake in writing: « Hydroxychloroquine 200mg/kg twice per day » It’s way over the common dosage.
View 2 replies
A french scientist
commented on 27 December, 2020
Dear M. Niaee. As you might know your study is referenced on this website http://www.metaevidence.org/viewPathology2.aspx?exposition=684&comparator=649&pathology=87&domain=12 as having a "high risk of bias". Expect fierce resistance to your findings by dogmatist western scientists that use specious arguments to bring down your excellent work. I would be happy to help you push the evidence in the right direction. We desperately need to make this drug widely accessible to end this pandemic. Thank you
View 1 reply
A chilean med student
replied on 30 December, 2020
Don't you think it's irresponsible to say "push the evidence in the right direction. We desperately need to make this drug widely accessible to end this pandemic" considering the evidence available to this date? I don't want to make judgements without all the facts, but there's a worrying amount of people lobbying for the emergency approval of IVM, considering it the "key" to ending the pandemic, when clearly it's not. Reminds a little of what happened with the hidroxicloroquine before studies started to show that it didn't work as promised, and harmed a lot of pacients in the process.
View 1 reply
Dr.niaee
replied on 30 December, 2020
Dear friends, we just tried to do our best and test ivermectin for treatment of Covid-19 patients to help these patients. Our findings and our further exprience on about 30,000 patients showed a promising result. We hope ivermectin could help our people, but for the judgment we need to test it in large populations. Lets hope...
View 1 reply
A chilean med student
replied on 30 December, 2020
You're right, and I'm sorry for sounding a bit to harsh in my previous comment. I hope that this and the other studies, along with the RCTs that're being made can help us to know more abut the effectiveness of this and other drugs. Best regards.
View 1 reply
Dr.niaee
replied on 31 December, 2020
Ofcourse, you're right. Thanks for your attention
Adriaan
commented on 04 January, 2021
Can you please explain the discrepancy between: "A total number of 180 mild to severe hospitalized patients with confirmed PCR and chest image tests were enrolled" and the fact that 52 patients had negative PCR in the Baseline table. If you can also comment on the statistically significant difference in PCR positiveness between the Control Groups (P and S) (47% PCR negative) and 20% on average for the other legs. These are points that will be used against this study.
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This is a preprint. It has not completed peer review.
Research Article
Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial
Nematollah Gheibi
Qazvin university of medical sciences
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 24 Nov, 2020
Community comments: 9
Metrics
Comments: 9
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
Background: It appears that ivermectin can potentially act against COVID-19 infection. Today, it is an urgent need to evaluate the efficacy and safety of ivermectin. The effect of ivermectin therapy on mild to severe COVID-19 patients was investigated.
Methods: A 45-days randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical trial was designed at five hospitals. A total number of 180 mild to severe hospitalized patients with confirmed PCR and chest image tests were enrolled. The radiographic findings, hospitalization and low O2 saturation duration, and clinical outcomes such as mortality and variables of blood samples were analyzed using standard statistical analyses in SPSS (V20).
Results: Average age of the participants was 56 years (45-67) and 50% were women. The primary and secondary results showed significant changes between day zero and day five of admission (∆ 0/5) in terms of ΔALC5/0, ΔPLT5/0, ΔESR5/0, ΔCRP5/0, duration of low O2 saturation, and duration of hospitalization (CI = 95% ). Risk of mortality was also decreased significantly in the study groups.
Conclusion: Ivermectin as an adjunct reduced the rate of mortality, low O2 duration, and duration of hospitalization in adult COVID 19 patients. The improvement of other clinical parameters showed that the ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.
Trial Registration: This trial was registered with the Iranian Registry of Clinical Trials website (registration ID IRCT20200408046987N1).
Figure 1
Figure 2
Jean-Claude Ghaleb
commented on 25 November, 2020
There’s probably a mistake in writing: « Hydroxychloroquine 200mg/kg twice per day » It’s way over the common dosage.
View 2 replies
Morteza Niaee
replied on 25 November, 2020
Hi dear friend, yes it's a typo, it will be corrected.
DJ
replied on 04 December, 2020
Clearly, that's a lethal dose. They mean 200mg tablets probably.
A french scientist
commented on 27 December, 2020
Dear M. Niaee. As you might know your study is referenced on this website http://www.metaevidence.org/viewPathology2.aspx?exposition=684&comparator=649&pathology=87&domain=12 as having a "high risk of bias". Expect fierce resistance to your findings by dogmatist western scientists that use specious arguments to bring down your excellent work. I would be happy to help you push the evidence in the right direction. We desperately need to make this drug widely accessible to end this pandemic. Thank you
View 1 reply
A chilean med student
replied on 30 December, 2020
Don't you think it's irresponsible to say "push the evidence in the right direction. We desperately need to make this drug widely accessible to end this pandemic" considering the evidence available to this date? I don't want to make judgements without all the facts, but there's a worrying amount of people lobbying for the emergency approval of IVM, considering it the "key" to ending the pandemic, when clearly it's not. Reminds a little of what happened with the hidroxicloroquine before studies started to show that it didn't work as promised, and harmed a lot of pacients in the process.
View 1 reply
Dr.niaee
replied on 30 December, 2020
Dear friends, we just tried to do our best and test ivermectin for treatment of Covid-19 patients to help these patients. Our findings and our further exprience on about 30,000 patients showed a promising result. We hope ivermectin could help our people, but for the judgment we need to test it in large populations. Lets hope...
View 1 reply
A chilean med student
replied on 30 December, 2020
You're right, and I'm sorry for sounding a bit to harsh in my previous comment. I hope that this and the other studies, along with the RCTs that're being made can help us to know more abut the effectiveness of this and other drugs. Best regards.
View 1 reply
Dr.niaee
replied on 31 December, 2020
Ofcourse, you're right. Thanks for your attention
Adriaan
commented on 04 January, 2021
Can you please explain the discrepancy between: "A total number of 180 mild to severe hospitalized patients with confirmed PCR and chest image tests were enrolled" and the fact that 52 patients had negative PCR in the Baseline table. If you can also comment on the statistically significant difference in PCR positiveness between the Control Groups (P and S) (47% PCR negative) and 20% on average for the other legs. These are points that will be used against this study.
Morteza Niaee
replied on 25 November, 2020
Hi dear friend, yes it's a typo, it will be corrected.
DJ
replied on 04 December, 2020
Clearly, that's a lethal dose. They mean 200mg tablets probably.