This study is being done at a hospital in Mexico. The ClinicalTrials write-up describes ivermectin as a "enzyme inhibitor" which I don't recall seeing before.
Ivermectin 12 mg PO every 24 hours for one day
??? Isn't that the same as "One 12mg dose"?
Bigger people will get 18mg. Standard dosing.
For some inexplicable reason, both the experimental group and placebo group will get placebo tablets for 4 days. ???
Interesting! Patients will be categorized into two groups based on whether their QTc is 500 ms.
Corrected QT interval (QTc) The corrected QT interval (QTc) estimates the QT interval at a standard heart rate of 60 bpm. This allows comparison of QT values over time at different heart rates and improves detection of patients at increased risk of arrhythmias.
Less than 500 ms, patients get HCQ + ivermectin. Greater than 500 ms, they just get ivermctin. This is because:
The risk of hydroxychloroquine complications will be assessed by QT corrected by Bazett formula.
Then the description gets totally confusing with this:
If QTc 500 ms could be randomized to hydroxychloroquine, ivermectin or placebo.
Say wut? You just said "No HCQ for you!" if QTc 500 ms.
NO ZINC!!
The HCQ/Zinc crowd will be bummed.
I don't know if the design is fucked, or just the person who entered the data into ClinicalTrials, or me -- but this registration is contradictory and confusing. Maybe the person who wrote it up isn't that great at English. As long as they do the work!
First results by the end of summer! :)
N = 200. That's bigger than all but one registered ivermectin study, IIRC.
Official Title: Efficacy and Safety of Hydroxychloroquine and Ivermectin in Hospitalized no Critical Patients Secondary to COVID-19 Infection: Randomized Controlled Trial
From the description:
In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results.
The "has been shown in vitro to reduce viral replication and" remark references Monash 48 hours.
The "n an observational cohort, greater viral clearance with promising clinical results" reference is to Patel Usefullness.
Continuing with the prescription, with reformatting:
Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients.
Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule.
Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day.
Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed.
If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned.
Outcomes: The primary outcome will be discharge from hospital for improvement.
The safety outcomes will be requirement of mechanical intubation, septic shock or death.
Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.
Estimated PrimaryCompletion Date: August 30, 2020
Estimated Study Completion Date : September 30, 2020
[-] TrumpLyftAlles | 5 points | May 18 2020 22:32:10
This study is being done at a hospital in Mexico. The ClinicalTrials write-up describes ivermectin as a "enzyme inhibitor" which I don't recall seeing before.
Ivermectin 12 mg PO every 24 hours for one day
??? Isn't that the same as "One 12mg dose"?
Bigger people will get 18mg. Standard dosing.
For some inexplicable reason, both the experimental group and placebo group will get placebo tablets for 4 days. ???
Interesting! Patients will be categorized into two groups based on whether their QTc is 500 ms.
Corrected QT interval (QTc) The corrected QT interval (QTc) estimates the QT interval at a standard heart rate of 60 bpm. This allows comparison of QT values over time at different heart rates and improves detection of patients at increased risk of arrhythmias.
Less than 500 ms, patients get HCQ + ivermectin. Greater than 500 ms, they just get ivermctin. This is because:
The risk of hydroxychloroquine complications will be assessed by QT corrected by Bazett formula.
Then the description gets totally confusing with this:
If QTc 500 ms could be randomized to hydroxychloroquine, ivermectin or placebo.
Say wut? You just said "No HCQ for you!" if QTc 500 ms.
NO ZINC!!
The HCQ/Zinc crowd will be bummed.
I don't know if the design is fucked, or just the person who entered the data into ClinicalTrials, or me -- but this registration is contradictory and confusing. Maybe the person who wrote it up isn't that great at English. As long as they do the work!
First results by the end of summer! :)
N = 200. That's bigger than all but one registered ivermectin study, IIRC.
Official Title: Efficacy and Safety of Hydroxychloroquine and Ivermectin in Hospitalized no Critical Patients Secondary to COVID-19 Infection: Randomized Controlled Trial
From the description:
In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results.
The "has been shown in vitro to reduce viral replication and" remark references Monash 48 hours.
The "n an observational cohort, greater viral clearance with promising clinical results" reference is to Patel Usefullness.
Continuing with the prescription, with reformatting:
Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients.
Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule.
Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day.
Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed.
If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned.
Outcomes: The primary outcome will be discharge from hospital for improvement.
The safety outcomes will be requirement of mechanical intubation, septic shock or death.
Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.
Wow: This study will take people up to age 90!
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