Cytodyn Inc (CYDY)

[CTMedic]

kgro,

I have not seen the evidence you claim that CRP is the best indicator of severe covid.It is certainly an indicator, but there are many.

For mortality, age remains the single biggest risk factor, with patients in there 80s having mortality 50 times higher than those in their 20s.

You are correct that CRP demonstrates inflammation. The tocilizumab study did select for patients with CRP > 75.

Please recall the clinical correlates (from the paper you noted) for high CRP.

Venous thrombo-embolism (VTE), acute kidney injury (AKI), critical illness, and in-hospital mortality were determined for all patients. Among 2782 patients hospitalized with COVID-19, 2601 (93.5%) had a CRP measurement [median 108 mg/L, interquartile range (IQR) 53–169]. CRP concentrations above the median value were associated with VTE [8.3% vs. 3.4%; adjusted odds ratio (aOR) 2.33, 95% confidence interval (CI) 1.61–3.36], AKI (43.0% vs. 28.4%; aOR 2.11, 95% CI 1.76–2.52), critical illness (47.6% vs. 25.9%; aOR 2.83, 95% CI 2.37–3.37), and mortality (32.2% vs. 17.8%; aOR 2.59, 95% CI 2.11–3.18), compared with CRP below the median

As discussed in the study you noted, CRP (as a measure of inflammation) is a good indicator of inflammation and dysfunction.

Did CD12 exclude patients based on CRP?

No, it did not.

It only limited ARDS to mild and moderate. The claim that CD12 excluded high risk patients is false.

Excluding some high risk patients is not the same as excluding all high risk patients.

As a reminder, the tocilizumab study was open label.

Cytodyn's CD12 leronlimab trial was double-blinded, placebo controlled.

Here are is a nice table summarizing other predictors of mortality.



Looking at this table, CD12 could have restricted patients based on age, liver function, kidney function, hyperkalemia, coagulopathy and hypovolemia.

However, these is a point at which section criteria are sufficiently selective.

Above all, please remember:

Cytodyn CD12 double blinded, placebo controlled

Tocilizumab RECOVERY trial open label

The results of CD12 will be available soon.

As a rigorous, randomized trial, there will be no doubt or conjecture about the results.

They either will or will not be statistically significant. We already know the selected endpoints are clinically significant. There is no endpoint for days to clinical improvement or resolution of myalgia.

As a review, the endpoints are:

Primary:

All-cause mortality at Day 28

Secondary:

All-cause mortality at Day 14
Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)
Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)
Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.


https://www.clinicaltrials.gov/ct2/show/NCT04347239?term=NCT04347239&draw=2&rank=1

While all of us have our beliefs and expectations of the trial outcome, none of us know yet.

Until then, let's be patient.

Thanks.