Research ProposalPDF Available

CORONA VIRUS/Covid/19 ARDS/ ACUTE RESPIRATORY DISTRESS SYNDROME HIGH DOSE IV METHYLCOBALAMIN IS A SAFE & COST EFFECTIVE RESCUE TREATMENT for ARDS

Authors:
  • University of Oxford St Catherine's College
Research Proposal

CORONA VIRUS/Covid/19 ARDS/ ACUTE RESPIRATORY DISTRESS SYNDROME HIGH DOSE IV METHYLCOBALAMIN IS A SAFE & COST EFFECTIVE RESCUE TREATMENT for ARDS

Abstract

Corona Virus/ Covid19/ SARS-2-Covid has ground the world to a halt and is showing up the deficiencies of our health care systems everywhere, and the vulnerability of the global population. When Covid/19 kills, it kills through Acute Respiratory Distress Syndrome/ ARDS which, in effect, kills by a sepsis related process. Thus ARDS is fuelled by the proverbial "cytokine storm". It is also known that people who die of Covid 19 ARDS have a depletion of Natural Killer/NK cells, and poor immune function in general. Whether the virus depletes NK c e l l s , o r w h e t h e r t h o s e w h o a r e i m m u n o-compromised/elderly lack normal NK cell levels and activity is not known for sure. At this point in time, when the FDA have suddenly relaxed many drug control regulations, in order to be able to use off-label drugs in a desperate attempt to mitigate disaster, the FDA actually already have one powerful item in the armoury, to which, because of its safety and cost-effectiveness, combined
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CORONA VIRUS/Covid/19 ADULT
RESPIRATORY DISTRESS SYNDROME
*************************************************
HIGH DOSE IV METHYLCOBALAMIN IS A
SAFE & COST EFFECTIVE RESCUE
TREATMENT for ARDS.
Dr Carmen Wheatley, St Catherine’s College, Oxford
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Corona Virus/ Covid19/ SARS-2-Covid has ground the
world to a halt and is showing up the deficiencies of
our health care systems everywhere, and the
vulnerability of the global population.
When Covid/19 kills, it kills through Acute
Respiratory Distress Syndrome/ ARDS which,
in effect, kills by a sepsis related process.
Thus ARDS is fuelled by the proverbial
“cytokine storm”. It is also known that people
who die of Covid 19 ARDS have a depletion of
Natural Killer/NK cells, and poor immune
function in general. Whether the virus depletes NK
cells, or whether those who are immuno-
compromised/elderly lack normal NK cell levels and
activity is not known for sure.
At this point in time, when the FDA have suddenly
relaxed many drug control regulations, in order to be
able to use off-label drugs in a desperate attempt to
mitigate disaster, the FDA actually already have
one powerful item in the armoury, to which,
because of its safety and cost-effectiveness, combined
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with efficacy, they granted Orphan Drug status some
years ago, for use in suspected terrorist CN gas
attacks. This Orphan drug is vitamin B12 as
hydroxocobalamin for high dose intravenous
administration, the safest and most efficacious CN
antidote on the planet.
For some years now I have been collaborating with
colleagues at the William Harvey Institute, London,
investigating in animal models the use of high dose IV
cobalamin for sepsis. We are now concluding pre-
clinical trial work defining more precisely the
mechanisms by which high dose IV cobalamin confers
protection in SIRS/Sepsis and septic shock.
ARDS is often a feature of sepsis and, as mentioned,
is driven by the self same unresolvable pro-
inflammatory response as sepsis .
Thus our research work is potentially very
applicable to ARDS/ Covid.19 crisis.
In yet to be published work, in which 6 different key
cobalamins were tested, we have discovered that high
dose methylcobalamin B12 is even more
efficacious in an animal model of sepsis than
is high dose hydroxocobalamin B12.
The protocol that I first discussed as potentially
suitable for SIRS/ sepsis/septic shock, -thus ARDS- in
a 2006 Medical Hypotheses paper, [available on my
Researchgate page] , has
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been shown by our William Harvey Institute animal
model work to be the dose equivalent in a human of
the anti-cyanide hydroxocobalamin B12 treatment.
This treatment already exists in Merck
Serono’s CyanoKit.
Based on our collective research insights, and on my
knowledge of the wider cobalamin lab research, and
of the lost, or forgotten, alternative clinical uses of
cobalamin literature, [going back to the 1950s], I
believe that:
The ideal RESCUE PROTOCOL FOR ARDS
would utilise 4 to 5 GRAMS of
methylcobalamin daily, administered by IV, in
saline, for anywhere between 1 to 5, or even 7
days, depending on response, as the safest and
potent ia ll y most effica ci ou s trea t me nt
available for viral sepsis related ARDS.
Crystalline methylcobalamin is available
worldwide for compassionate grounds use at
these doses. However, where it is impossible to
obtain methylcobalamin for the implementation of
this protocol,
Merck Serono’s CyanoKit, which is licensed,
would be a good second best.
This protocol has already been deployed
clinically in other diverse extreme scenarios:
my draft clinical trial protocol gives references
showing high dose IV cobalamin efficacy in refractory
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vasoplegic syndrome, both in cardiac surgery and in
liver transplants; in CO and H2S poisoning; and in
nitrous oxide poisoning.
The near miraculous rescue impact of high
dose cobalamin IN ONE OF MANY DIVERSE
EMERGENCY SCENARIOS is well illustrated in
the following case history. The authors used the anti
CN protocol [Mercks Cyanokit], whose potential for
sepsis -thus also ARDS- was first discussed in my
2006 paper, to rescue a surgical patient from N2O
overdose:
Laoutid J, Jbili N, Bibiche L, Kechna H, Hachimi MA.
Delayed neurologic sequelae following anoxic-anoxia
related to nitrous oxide by pipeline mix-up during
anesthesia. Edorium J Anaesthesia. 2017;3:7– 11.
This case history above describes a major surgical
accident of a 36 year old lady, who was accidentally over
exposed to nitrous oxide, an anaesthetic gas known to
inactivate B12 enzyme pathways, and which thus has the
potential to cause a functional B12 deficiency, even in the
absence of negative B12 deficiency tests. A similar
accident in the USA in 2002 killed 2 people, and the N2O
accident literature shows next to no survivals.
The lady ended up with alarming neurological symptoms
within 48 hrs of the accident. She lost the use of all her
limbs/ascending paraesthesia. She had dysarthria. She
would have continued to deteriorate, but....!
It seems, [cf. their citation and protocol that they then
used], that the doctors had read the paper I published in
2006, advocating the use of supra-therapeutic doses of
B12, for sepsis, septic shock and SIRS, -at the very same
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dose used for cyanide poisoning treatment, a massive
dose, of a different order of magnitude even to the high
doses of methylcobalamin some doctors across the world
now use on a regular basis i.m.
These doctors made a good judgement.!
!
They appreciated there was no downside, -a life was at
stake, -since the N2O accident literature shows no-one so
exposed usually survives - and that high dose IV B12/
HOCbl is supremely safe, after over half a century's!
experience of this dose in French and other ICUs.!
Anyway, the doctors went for broke, and look what
happened to this lady in a very short time scale: - nothing
short of miraculous:
"The duration of surgery was one hour. The awakening
was restless and the patient was sedated for 24 hours by
midazolam-fentanyl at the ICU. Non contrast cerebral
scan was without anomalies. The patient was extubated
the next day without neurological deficit. At the night of
the second postoperative day, the patient presented
symmetrical paresthesia on the feet, ascending to the
trunk, chest and both arms. This was followed by
weakness and clumsiness of all limbs, loss of their use and
dysarthria, mental status was normal.
Before any specific therapy, vitamin B12 and
homocysteine (HC) was tested. Methylmalonic acid
(MMA) was not tested. Cerebrospinal MR Imaging was
normal. Delayed neurologic sequelae due to the anoxic-
anoxia were suspected and neuropathy secondary to N2O
toxicity was evocated too.
Before receiving the results from the laboratory, we
decided to begin a course of vitamin B12
6
(hydroxocobalamin) injections: 5 grams/day.!
!
Biological exams received, two days after, showed normal
vitamin B12 at 785 pg/mL (normal 193–982 pg/mL) and
normal HC level at 7 µmol/L (normal < 10 µmol/L) which
permitted us to eliminate the diagnosis of nitrous oxide
myelopathy.!
Amelioration was noted from the second
injection, the numbness decreased, so we decided
to maintain vitamin B12 therapy 5 grams/ day for
one week then 5 grams/week for two months. The
patient could walk within five days and she was
discharged from the hospital after one week with
a light dysarthria. She has fully recovered in two
months. One year later, the patient was healthy
without any sequela.”
*****************************************************
N2O poisoning is not Sepsis/ARDS. I give this here
only as one dramatic example of cobalamin’s cinical
potential for diverse extreme scenarios in general.
More pertinent to the way that Covid 19 kills, and how
high dose parenteral cobalamin can combat this, is the
known fact that cobalamin boosts Natural Killer
cell levels, increases phagocytosis, and is
critical for the regulated pro-inflammatory
and anti-inflammatory sequence of the
immune response.
A small literature shows that high dose parenteral
cobalamin has anti-viral actions, including
against HIV, and it has been used with clinical
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success to treat hepatitis. These immune
regulating effects of cobalamin have been
demonstrated both in vitro and in clinical studies.
[For extensive references in support of all the above
statements, please see my imminent allied
Researchgate post: The Effects of Cobalamin on
the Immune Response].
Thus, all indications from the WHI research are that
HIGH DOSE IV COBALAMIN, in particular
methylcobalamin, is a rescue treament well worth
trying now
for the Covid.19 ARDS crisis.
COBALAMIN IS LICENSED, SAFE
AND COST EFFECTIVE.
There is nothing to lose and everything to gain.
Moreover, high dose methylcobalamin could also be
safely and easily deployed at lower high doses, by
intramuscular injection, -as per my draft
methylcobalamin for sepsis clinical protocol, - as
both a potential prophylactic, and a mitigating
treatment for Covid 19 cases that end up in
hospital, to prevent such patients proceeding
to full blown ARDS.
This would obviously take huge pressure off
our collapsing health systems worldwide.
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NB Extensive Pharmacological Safety
References, dating back more than half a
century, for the clinical use of High Dose IV
Hydroxocobalamin B12
start on page 14 of my draft Methylcobalamin
for Sepsis prevention and treatment clinical
trial protocol:
[This sepsis protocol is now available on my
Researchgate page as work in progress.
I will be revising the core of this clinical
protocol in the coming week, as, mutatis
mutandi, it is easily adaptable for the
treatment of ARDS].
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PLEASE BRING THIS ARTICLE AND THE
R EL A T E D D R A F T P R O TO C O L ON M Y
RESEARCHGATE PAGE TO THE ATTENTION
OF ANY INTERESTED ICU PHYSICIAN
ANYWHERE IN THE WORLD.
If you wish to contact me more directly to
discuss implementation of this potential
therapy, please email me on:
wheatley.carmen@googlemail.com
I will be happy to help any doctor anywhere with the
compassionate grounds use of cobalamin for Covid 19.
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ResearchGate has not been able to resolve any citations for this publication.
ResearchGate has not been able to resolve any references for this publication.