New #ACTIV6 results: high dose ivermectin (600 mcg/kg x 6 days) does NOT improve outcomes in COVID19
- n=1206 outpatients randomized to IVM vs placebo
- no difference in time to recovery (11 vs 11 days)
- no difference in mortality or hospitalization
📄medrxiv.org
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- n=1206 outpatients randomized to IVM vs placebo
- no difference in time to recovery (11 vs 11 days)
- no difference in mortality or hospitalization
📄medrxiv.org
1/
Some context:
#ACTIV6 is a large double blind RCT investigating repurposed drugs in outpatients w/ COVID19. Patients had to be >30 yo & have symptomatic COVID.
Previously we looked at the lower dose arm of ACTIV6 (IVM 400 mcg/day x 3 days) which was stone cold NEGATIVE.
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#ACTIV6 is a large double blind RCT investigating repurposed drugs in outpatients w/ COVID19. Patients had to be >30 yo & have symptomatic COVID.
Previously we looked at the lower dose arm of ACTIV6 (IVM 400 mcg/day x 3 days) which was stone cold NEGATIVE.
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The ACTIV6 study was a decentralized study performed at 93 sites in the US. Participants could be enrolled by phone & would be shipped study drug next day.
This pragmatic design allowed them to enroll ~1200 people between February & June 2022 (the Omicron period).
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This pragmatic design allowed them to enroll ~1200 people between February & June 2022 (the Omicron period).
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Depending on weight the patient was instructed how many pills to take. The IVM dose was *up to* 600 mcg/kg.
Depending on weight every patients received between 400 & 600 mcg/kg. (The median dose was 500 mcg/kg)
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Depending on weight every patients received between 400 & 600 mcg/kg. (The median dose was 500 mcg/kg)
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500 mcg/kg x 6 days is high dose!
FDA approved dose of IVM (for worms) is 200 mcg/kg once.
Back in Dec 2020 when Pierre Kory was telling congress that ivermectin was a “miracle cure”, he recommended 300 mcg/kg x 5 days!
Every ACTIV6 pt got a higher than “miracle cure” dose!
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FDA approved dose of IVM (for worms) is 200 mcg/kg once.
Back in Dec 2020 when Pierre Kory was telling congress that ivermectin was a “miracle cure”, he recommended 300 mcg/kg x 5 days!
Every ACTIV6 pt got a higher than “miracle cure” dose!
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The patients enrolled in ACTIV are pretty representative of US in 2022:
- about half over 50 yo
- about a third were obese
- many had typical comorbidities (HTN, Asthma, DM, etc) that can be high risk in COVID
- about 80% were fully vaccinated (at least 2 shot primary series)
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- about half over 50 yo
- about a third were obese
- many had typical comorbidities (HTN, Asthma, DM, etc) that can be high risk in COVID
- about 80% were fully vaccinated (at least 2 shot primary series)
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Most people received the study med within a few days of onset. Median 5 days.
(This is pretty reasonable when you consider that patients had to test positive, enroll, & get medication shipped to them.)
Also, crucially, early treatment made no difference in outcomes!
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(This is pretty reasonable when you consider that patients had to test positive, enroll, & get medication shipped to them.)
Also, crucially, early treatment made no difference in outcomes!
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The study was stone-cold negative.
No difference in the primary endpoint of time to symptom recovery: 11.2 vs 11.3 days.
There were numerically more deaths & hospitalizations among those treated with ivermectin (though very few, presumably because >80% were vaccinated)
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No difference in the primary endpoint of time to symptom recovery: 11.2 vs 11.3 days.
There were numerically more deaths & hospitalizations among those treated with ivermectin (though very few, presumably because >80% were vaccinated)
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It’s pretty clear from #ACTIV6 - a large DB RCT - that high dose ivermectin isn’t beneficial in terms of preventing hospitalization, death, or making patients recover from COVID faster.
This ought to 🔨the final nail in the “ivermectin cures COVID” ⚰️.
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This ought to 🔨the final nail in the “ivermectin cures COVID” ⚰️.
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