Misui has pointed out another potential problem (e

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Misui has pointed out another potential problem (early discharge without further LL treatment). There are probably 10 others, which might only be obvious in hindsight.

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Critical trial -

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Leronlimab 700 mg intravenously once a week (up to 4 doses) until hospital discharge

primary endpoint - Cumulative proportion of clinical recovery [ Time Frame: 28 days ]
Patients will be considered to have recovered if they attain categories 1, 2, or 3 on the eight-category ordinal scale within 28 days, as follows:

1. Not hospitalized, no limitations on activities
2. Not hospitalized, limitation on activities and/or requiring home oxygen
3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care

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As can be seen this is no problem. If they attain 1,2 or 3 at any time within 28 days they are considered to be clinically recovered.

For secondary endpoints those who are discharged will have follow up to day 28 for the primary part of the trial and then a further 60 day follow up.

Severe follows the same pathway for within 28 days except a primary endpoint of - Cumulative incidence of death or respiratory failure until day 28.

Both are leronlimab injections until hospital discharge. Which would be low flow oxygen at worst. In the ordinary course of things in Brazil they may try to speed patients out at the first sign of recovery. In a clinical trial they'll take more care.

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I think Ohm even has stated that he had one concern about CD12 (uneven enrollment), and it came to pass.

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I had two concerns, skew towards those more likely to die in the leronlimab arm and a prepondarance of severe over critical. I thought both unlikely but both occurred.

Where I was really blindsided was assuming most of the EINDs were two dose so I never considered that a factor.