Regeneron Halts Enrollment of Critically Ill Patients in COVID-19 Antibody Trial (Potential issues with this group)

https://www.biospace.com ^ | 10.30.2020 | Brandon May

[rxsid]

Regeneron Halts Enrollment of Critically Ill Patients in COVID-19 Antibody Trial

Regeneron Pharmaceuticals has decided to halt enrollment of very sick patients with COVID-19 in its trial studying antibody cocktail REGN-COV2

...

The decision to halt critically ill patients was made in response to Regeneron’s independent safety board finding a potential safety signal and an unfavorable risk-benefit profile of the monoclonal antibody therapy in a subgroup of patients requiring high-flow oxygen or mechanical ventilation. These patients are generally sicker and hospitalized because they are in the advanced stages of the disease.

The Tarrytown, N.Y.-based pharmaceutical company says it is blinded to the trial data. As such, the company did not provide specific details in their Friday morning statement on what the safety signal was or in which group experienced the unexpected event. The hold on enrollment will stay in place until the independent data monitoring committee can collect and evaluate further data on severely ill patients currently enrolled in Regeneron’s trial.

Regeneron also says it has informed the U.S. Food and Drug Administration (FDA) of the safety signal and the decision to halt new enrollment of critically ill patients. The agency is currently evaluating the therapy for a possible emergency use authorization (EUA) in mild-to-moderate patients with COVID-19 who are at high risk for poor outcomes.

While patients with severe disease will be excluded from the trial from this point forward, Regeneron will continue enrolling other types of patients. These will include non-hospitalized patients as well as hospitalized patients who require either no or minimal levels of supplemental oxygen.

[rxsid]

At this point and for this group, severely ill (& potentially less ill as well), it still looks like Aviptadil is the answer.

[rxsid]

Additional information:

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

[lepton]

What do they expect when they put the Headless Horseman in charge of medical studies?

[Jim Noble]

I think by the time people are critically ill the virus is mostly gone, we’ve never had any luck with antivirals at that point - not HCQ, not remdesivir, not plasma.

There are no trials of antivirals (that I have seen) that show any benefit at that point.

Decadron and IL-6 inhibitors, especially with anticoagulation, yes. But not antivirals.

[Ragnar54]

No, fast acting vitamin D is the answer.

In a new study, 76 patients with Covid-19 were treated: 26 with "standard of care" and 50 with "standard of care" + a high dose Vitamin D analog (calcifediol ).

For the group receiving calcifediol, only 1 (of 50) had to go to the ICU, and none died.
For the group not receiving calcifediol, 13 (of 26) went to the ICU and 2 died.

Given the proven effectiveness of Vitamin D against respiratory infections in the past, one physician was appalled that the CDC had not already done a similar study. We can expect the bureaucrats to ignore this study. The reason is now clear: their Chinese masters want the fear porn to continue so as to lift Jo and the Ho into power.

The study:

“Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”

Here is an analysis of the study:
Vitamin D, First clinical trial

Here is another analysis of the same study:
New Study - Vitamin D High Dose and COVID-19

Calcifediol raises blood levels of Vitamin D quickly. This is because it is the same as what the liver produces from regular vitamin D. Processing by the liver introduces days of delay, which might have been fatal for some of the Chinese Virus patients in this study. It is probably a good idea to get a prescription for Calcifediol and have some handy in case you develop Chinese Virus symptoms.

The only real side effect of using Vitamin D is that it is incredibly cheap compared to the drugs in the patent royalty competition. The retail cost of the amount of calcifediol used in the study is probably less than $2000 per patient (assuming a 2-3 week course). If people became aware of the effectiveness of Vitamin D against the Chinese Virus, they might start taking preventive doses of "ordinary" (slow acting cholecalciferol) Vitamin D, and that would be disastrous to the Covid fear porn royalty derby. A good preventive dose is 10,000 IU per day, requiring 13 bottles of 60 5,000 IU softgels per person per year at less than $100 ($7.50 per bottle from lef.org, cheaper elsewhere).

Please contact your Senators, Congressmen and the President and ask that the CDC be required to duplicate this study for a larger group. Such a study would be inexpensive and would not take long (on the order of weeks, less time than we are being asked to wait for the vaccine). The CDC should also be told to test the Vitamin D level of all Covid-19 patients.

[CharlesWayneCT]

I’m taking D, but nowhere NEAR a 10,000 IU dose. 4500 is like a maximum, and I’m taking about 1300.

[Ragnar54]

Fauci said in an email (as reported on a website, and not refuted) that he takes 6,000. I would guess that he weighs no more that 140. I am a more "normal" 200 and I take 8,000. I will have to increase to 10,000. The amount required to reach a certain blood level depends on your volume as well as your percent body fat, since Vitamin D is fat-soluble (my personal opinion of Dr. Fauci is that he is a bit scrawny)

The important questions are what is your vitamin D blood level and what is your calcium blood level. My Vitamin D level is only 40, and my calcium level is normal.

There is an article on NIH by a Canadian physician (Dr. Gerry Schwalfenberg) who works in nursing homes. He has developed a protocol for reducing flu like illness among his patients. This should be tried against the corona virus in US hospitals:

"A colleague of mine and I have introduced vitamin D at doses that have achieved greater than 100 nmol/L in most of our patients for the past number of years, and we now see very few patients in our clinics with the flu or influenzalike illness. In those patients who do have influenza, we have treated them with the vitamin D hammer, as coined by my colleague. This is a 1-time 50 000 IU dose of vitamin D3 or 10 000 IU 3 times daily for 2 to 3 days. The results are dramatic, with complete resolution of symptoms in 48 to 72 hours. One-time doses of vitamin D at this level have been used safely and have never been shown to be toxic. We urgently need a study of this intervention. The cost of vitamin D is about a penny for 1000 IU, so this treatment costs less than a dollar."

Vitamin D for influenza

There is a presentation by Dr. Robert P Heaney on the healthful effects of adequate vitamin D levels:

Vitamin D Sunshine Optimal Health: Putting it all Together

There is an article by Beata M. Gruber-Bzura on NIH that describes the mechanisms by which vitamin D works with the immune system:

"There are a few arguments which support vitamin D as a likely candidate for the abovementioned “seasonal stimulus”. In summary, most important is the 1α,25(OH)2D-stimulated production of AMPs, such as defensin and cathelicidin. As mentioned, these endogenous antibiotics act directly, destroying not only microbial pathogens, but also viruses, including the influenza virus [24,48,49]. The production of cathelicidin is dose-dependent on the serum level of 1α,25(OH)2D. "

Vitamin D and Influenza—Prevention or Therapy?

[Ragnar54]

Fauci said in an email (as reported on a website, and not refuted) that he takes 6,000. I would guess that he weighs no more that 140. I am a more "normal" 200 and I take 8,000. I will have to increase to 10,000. The amount required to reach a certain blood level depends on your volume as well as your percent body fat, since Vitamin D is fat-soluble (my personal opinion of Dr. Fauci is that he is a bit scrawny)

The important questions are what is your vitamin D blood level and what is your calcium blood level. My Vitamin D level is only 40, and my calcium level is normal.

There is an article on NIH by a Canadian physician (Dr. Gerry Schwalfenberg) who works in nursing homes. He has developed a protocol for reducing flu like illness among his patients. This should be tried against the corona virus in US hospitals:

"A colleague of mine and I have introduced vitamin D at doses that have achieved greater than 100 nmol/L in most of our patients for the past number of years, and we now see very few patients in our clinics with the flu or influenzalike illness. In those patients who do have influenza, we have treated them with the vitamin D hammer, as coined by my colleague. This is a 1-time 50 000 IU dose of vitamin D3 or 10 000 IU 3 times daily for 2 to 3 days. The results are dramatic, with complete resolution of symptoms in 48 to 72 hours. One-time doses of vitamin D at this level have been used safely and have never been shown to be toxic. We urgently need a study of this intervention. The cost of vitamin D is about a penny for 1000 IU, so this treatment costs less than a dollar."

Vitamin D for influenza

There is a presentation by Dr. Robert P Heaney on the healthful effects of adequate vitamin D levels:

Vitamin D Sunshine Optimal Health: Putting it all Together

There is an article by Beata M. Gruber-Bzura on NIH that describes the mechanisms by which vitamin D works with the immune system:

"There are a few arguments which support vitamin D as a likely candidate for the abovementioned “seasonal stimulus”. In summary, most important is the 1α,25(OH)2D-stimulated production of AMPs, such as defensin and cathelicidin. As mentioned, these endogenous antibiotics act directly, destroying not only microbial pathogens, but also viruses, including the influenza virus [24,48,49]. The production of cathelicidin is dose-dependent on the serum level of 1α,25(OH)2D. "

Vitamin D and Influenza—Prevention or Therapy?

[Trump Girl Kit Cat]

I take 5,000 units a day fast acting, have been for years!!!