This is the 44th ivermectin vs covid19 trial registered at ClinicalTrials. Completed but no results: I contacted the lead author via twitter @okumus_nurullah to ask if there's a report.
Small N=60, randomized, not blinded, has a control group!
Treatment: 200mcg/kg of IVM for 5 days, plus standard care: HFA (hydroxychloroquine, favipiravir and azithromycin)
Control: Just HFA
17 (!) primary outcome measures:
1) Gender distribution of the patients [ Time Frame: At the first day of the study ]
I'm pretty sure they're not expecting any gender changes; that's not a known side-effect of ivermectin.
10 secondary outcome measures.
Detailed Description: Patients with severe COVID-19 pneumonia were included in the study. Two groups, the study group and the control group, took part in the study.
Ivermectin 200 mcg/kg/day for five days (9 mg between 36-50 kg, 12 mg between 51-65 kg, 15 mg between 66-79 kg and 200 microgram/kg in 80 kg) in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days) + favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) + azithromycin (first day 500mg followed by 4 days 250mg/day, po, total 5 days)- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin.
The mutations in 29 pairs of primers in mdr1/abcab1 gene by sequencing analysis using Sanger method, and the haplotypes and mutations of the CYP3A4 gene that cause the function losing were investigated among the patients who meet criteria and who were included in the study group according to randomization. Mutation screening was done when the first dose of the research drug ivermectin was given, ivermectin treatment was not continued in patients with mutations detected as a result of genetic examination and these patients were excluded from the study.
Disqualifying patients because of genes? Perhaps because of the single known case of a kid who went into coma after taking ivermectin, because of a very rare mutation, who recovered in 2 days?
Patients were followed for 5 additional days after treatment. At the end of the treatment and follow-up period (At the end of 10th day), clinical response and changes in oxygenation and laboratory parameters were evaluated.
I'll leave it at that. Let's hope the trial report comes out soon!
Is this kind of post still interesting? Let me know if it's not, save me the trouble of bothering.
[-] TrumpLyftAlles | 3 points | Dec 01 2020 01:56:43
This is the 44th ivermectin vs covid19 trial registered at ClinicalTrials. Completed but no results: I contacted the lead author via twitter @okumus_nurullah to ask if there's a report.
Small N=60, randomized, not blinded, has a control group!
Treatment: 200mcg/kg of IVM for 5 days, plus standard care: HFA (hydroxychloroquine, favipiravir and azithromycin)
Control: Just HFA
17 (!) primary outcome measures:
1) Gender distribution of the patients [ Time Frame: At the first day of the study ]
I'm pretty sure they're not expecting any gender changes; that's not a known side-effect of ivermectin.
10 secondary outcome measures.
Detailed Description: Patients with severe COVID-19 pneumonia were included in the study. Two groups, the study group and the control group, took part in the study.
Ivermectin 200 mcg/kg/day for five days (9 mg between 36-50 kg, 12 mg between 51-65 kg, 15 mg between 66-79 kg and 200 microgram/kg in 80 kg) in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days) + favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) + azithromycin (first day 500mg followed by 4 days 250mg/day, po, total 5 days)- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin.
The mutations in 29 pairs of primers in mdr1/abcab1 gene by sequencing analysis using Sanger method, and the haplotypes and mutations of the CYP3A4 gene that cause the function losing were investigated among the patients who meet criteria and who were included in the study group according to randomization. Mutation screening was done when the first dose of the research drug ivermectin was given, ivermectin treatment was not continued in patients with mutations detected as a result of genetic examination and these patients were excluded from the study.
Disqualifying patients because of genes? Perhaps because of the single known case of a kid who went into coma after taking ivermectin, because of a very rare mutation, who recovered in 2 days?
Patients were followed for 5 additional days after treatment. At the end of the treatment and follow-up period (At the end of 10th day), clinical response and changes in oxygenation and laboratory parameters were evaluated.
I'll leave it at that. Let's hope the trial report comes out soon!
Is this kind of post still interesting? Let me know if it's not, save me the trouble of bothering.
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[-] IcyEven | 2 points | Dec 01 2020 22:13:50
It is still interesting to me, thank you for posting.
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[-] TrumpLyftAlles | 1 points | Dec 01 2020 23:01:25
Thanks for letting me know!
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