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PROPUESTA APOYO GUBERNAMENTAL PARA APLICACIÓN VITAMINA C
#1
Al final del post, hay dos enlaces para que  puedan descargar los dos PDF originales, con las gráficas y todo.

PROPUESTA APOYO GUBERNAMENTAL PARA APLICACIÓN VITAMINA C INTRAVENOSA EN PACIENTES CON COVID-19 P.R.
17 April 2020

8 de abril de 2020.


HONORABLES:

WANDA VAZQUEZ GARCED, GOBERNADORA
LORENZO GONZALEZ FELICIANO, SECRETARIO DE SALUD
TASK FORCE COVID-19
LEGISLADORES DEL PUEBLO DE P.R.


RE: PROPUESTA APOYO GUBERNAMENTAL PARA APLICACIÓN VITAMINA C
INTRAVENOSA EN PACIENTES CON COVID-19 P.R.

El Puerto Rico Integrative Medicine Association, es una organización profesional sin fines de lucro compuesta por médicos, científicos, naturópatas, nutricionistas y otros profesionales de la salud especializados en Medicina Funcional, Regenerativa y Ortomolecular. Su propósito es empoderar a la comunidad en temas de optimización de la salud y a su vez promover el avance de la medicina mediante la investigación, la educación y el servicio, con énfasis en métodos tradicionales e innovadores, seguros, efectivos y científicamente estudiados y comprobados como son la bioquímica nutricional, la farmacológica, la optimización metabólica y otros ampliamente estudiados y basados en ciencia.
Debido a la situación de emergencia que se encuentran todos los ciudadanos del pueblo de Puerto Rico ante la pandemia del CoVid-19, enfermedad de alta contagiosidad, su seria morbilidad y su alta mortalidad asociada y la ausencia hasta el presente de tratamientos aprobados, proponemos a las autoridades nos apoyen la iniciativa para fomentar y autorizar el uso de emergencia de vitamina C (Ácido Ascórbico) por vía intravenosa para el manejo de pacientes positivos al CoVid-19 hospitalizados con enfermedad severa dentro del contexto de un protocolo de investigación clínica aprobado por el comité de derechos humanos (IRB, Institutional Review Board). Como objetivo adicional, nos proponemos, el apoyar el desarrollo de mecanismos para producir vitamina C de manera industrial y resiliente, y evitar la casi total dependencia de suplidores foráneos los cuales no garantizan alta calidad, y que actualmente apenas pueden suplir la demanda y a su vez esto nos permite desarrollar una industria que puede generar actividad económica. La producción industrial de ingredientes químicos fue una industria importante en Puerto Rico por lo cual la experiencia y la infraestructura está disponible para renovarla por la seguridad nacional de los puertorriqueños.
Debido a la urgencia de la situación del CoVid-19 en Puerto Rico, proponemos que definamos los objetivos por orden de prioridad de la siguiente manera:
1. Autorizar y promover mediante mandato de la Gobernadora, los Legisladores, el Secretario de Salud y el Task Force del CoVid-19, el uso de vitamina C intravenosa en PR Puerto Rico para pacientes con CoVid-19 hospitalizados que sean admitidos en el estudio clínico aprobado por el comité de derechos humanos (IRB) bajo el protocolo establecido en dicho estudio.
2. Autorizar un fondo de emergencia para adquirir vitamina C intravenosa. El proceso de compra debe ser ágil, ético y transparente para poder adquirirla lo más rápido posible y comenzar a dar tratamiento a los pacientes lo antes posible pues lamentablemente ya están muriendo personas. La vitamina en cuestión debe cumplir con todos los parámetros de calidad y seguridad.  La vitamina C está escaseando a nivel mundial y puede ser difícil conseguir.
3. Debemos hacer disponible educación e información adecuada sobre el estudio de la vitamina C intravenosa para los profesionales (mini talleres virtuales / información escrita) y para el público general (conferencia/comunicados de prensa).
4. La fabricación farmacéutica local de la vitamina C intravenosa es un proceso que tendría beneficios de salud para nuestros ciudadanos y para nuestra economía.  Este proceso es viable ya que tenemos infraestructura y recursos humanos extremadamente competentes. De hecho, conocemos personas de la industria farmacéutica que han estado trabajando en esta dirección y ya se han hecho inversiones considerables. Entendemos que actualmente el factor limitante es lograr atraer más capital para este proyecto. Este tipo de proyecto es importante porque fortalece nuestra economía y nos da herramientas poderosas para mejorar la salud y garantizar la calidad de las drogas que se manufacturan bajo las buenas prácticas de manufactura federal regulados por la FDA.
5. Adjunto se aneja a esta carta un resumen de la información pertinente al uso terapéutico de ácido ascórbico intravenoso para CoVid-19 debidamente referenciado con publicaciones en revistas médicas/científicas arbitradas.
Esperamos su pronta atención a esta propuesta y les expresamos que estamos a su disposición para cualquier información adicional y/o cualquier duda con respecto a lo antes expresado. Así mismo, estamos disponibles para reunirnos de forma virtual y/o a través de televideo, conferencia por Zoom o Skype. Mi número de teléfono es el (787) 354-0758.

Atentamente,


_____________________________________
Raúl H. Morales-Borges, MD / Presidente, PRIMA


[b]Data Summary to Support High Dose Ascorbic Acid Infusion for the Treatment of Severe 2019-nCoV Viral Pneumonia[/b]

Based on Emergency Clinical Research Proposal to be conducted in Puerto Rico
Dr. Víctor A. Marcial-Vega, MD, Adjunct faculty, School of Medicine, UCC, Dr. Jorge R Miranda-Massari,
PharmD, Professor, School of Pharmacy, MSC, UPR and Dr. Michael J González, DSc, NMD, PhD
Professor, School of Public Health, MSC, UPR and others.
Brief Summary:
The new coronavirus (2019-nCoV) and its pulmonary and systemic complications have
caused worldwide concern and emergency. There is a lack of effective targeted antiviral
drugs, and symptomatic supportive treatment is the only therapeutic approach for severe
acute respiratory infection (SARI).
Ascorbic acid (AA) is an essential nutrient with important and diverse physiological effects.
Moreover, at high doses (7,500 and over mg/day), especially when producing high
micromolar or milimolar concentrations it has been shown to exhibit pharmacological
properties. Among its many actions, it plays a role in reducing inflammation, (a
precipitating factor in SARI), supporting various aspects of the immune system and has a
direct antiviral effect.
A number of studies describe an array of mechanisms by which ascorbic acid enhances the
function of leukocytes including chemokinesis and chemotaxis properties
1
, phagocytosis 2 , production of lysosomal enzymes 3 , generation of reactive oxygen species 4 ,
and microbial killing 5 , up-regulation of antibody response 6 and increased interferon 7 .
These effects, as well as enhanced neutrophil chemotactic capacity 8,9 , have also been
documented in humans ingesting gram doses of vitamin C.
In addition, studies have shown clinical benefits which include lowering and reducing the
risk of infection 10 , 11 . Studies in animal models have demonstrated that parenteral ascorbate
improves sepsis and sepsis-induced multiple organ dysfunction syndrome via preventing of
cellular immunosuppression 12 . Studies in septic mice suggest that increased survival occurs
by activation of Nrf2/HO-1 signals 13 .
In-vitro observations with pharmacologic concentrations (millimolar range) suggest a direct
antiviral effect of ascorbate 14 consistent with clinical observations of patients with Epstein-
Barr viral (EBV) infection. There was a significant reduction of the EBV antibodies upon
pharmacologic intravenous ascorbate therapy 15 . Moreover, intravenous ascorbic acid has
demonstrated clinical benefits in different viral infections 16,17,18,19 .
Sepsis is a systemic response of an infection that results in an overwhelming production of
reactive oxygen species (ROS) with widespread injury to multiple tissues, cells and
organelles leading to progressive organ failure. The severe immune reaction in which the
1body releases too many cytokines into the blood too quickly produces an uncontrolled burst
of damaging ROS is known as the cytokine storm and represents an important complication
of covid1-9 infection 20 . In summary, over 500 peer reviewed experimental and clinical
studies have been published, clearly demonstrating the biologic credibility and biological
and pharmacologic mechanisms of vitamin C alone or combined with other agents in the
management of sepsis and other inflammatory disorders 21,22 . Based on these concepts, the
most comprehensive randomized study using intravenous ascorbic acid in 167 patients with
severe acute respiratory failure demonstrated at day 4 and forward significant reduction in
mortality in the ascorbic acid group when compared to placebo (p = 0.023) 23 . (see figure 1)
Figure 1. Patients With Sepsis and Severe Acute Respiratory Failure
Most vertebrates respond to a physiological stress such as sepsiFFigures with a dramatic
increase in the synthesis of ascorbate by converting glucose by means of the enzyme l-
gulono-g-lactone oxidase (GLO). When sufficient ascorbate is present, it helps: control
excess inflammation, support leukocyte function, inhibit microbial pathogen growth and
neutralize harmful ROS. However, since humans lack the GLO enzyme, we are not able to
2synthetize ascorbate and must acquire nutritional or pharmacologic doses according the
particular physiologic demands at hand.
Some recent studies suggest that the use of ascorbic acid as part of a protective protocol
against sars-covid-2 can reduce mortality in patients hospitalized in intensive care units with
sepsis. This ascorbic acid protocol can significantly reduce mortality from sepsis 24 , reduce
ICU stay length 25 and significantly reduce the time to resolution of shock 26 . The use of
ascorbic acid injections also improved the ventricular function (EF) 72 h after surgery and
reduced the length of ICU stay in patients undergoing coronary artery bypass surgery 27 .
The use of ascorbic acid as an effective antiviral has been documented as early as 1949
when Frederick R. Klenner, MD, documented the ability of vitamin C to reliably cure many
different acute infectious diseases and to reliably neutralize any toxin treated, when
sufficiently dosed and administered for a long enough period of time 28 including the cure of
60 out of 60 (100%) patients with polio within 4 days of ascorbic acid administration
intramuscularly and orally 29 . He also reported the cure of advanced polio and its associated
flaccid paralysis with ascorbic acid in 1951 30 .
A paper by Marcial-Vega et al reported on the efficacy and safety of the use of intravenous
25-50 grams of ascorbic acid in the treatment of 56 patients with Chikungunya. These
patients reported clinical improvements with no reported side effects. This protocol showed
that the use of intravenous hydrogen peroxide and ascorbic acid is safe and strongly
associated with a more than 71% post-infusion reduction of pain in patients affected with
Chikungunya virus related arthralgia 31 .
These results are consistent with previous in-vitro research which has shown that ascorbic
acid inactivates the polio 32 , herpes 33 , vaccinia 34,35 , tobacco mosaic 36 , bacteriophage 37,38,39,40 ,
entero 41 , influenza 42 and rabies 43 viruses.
They are also consistent with previous clinical research showing ascorbic acid can resolve
polio 9,10,11,44,45 , its associated flaccid paralysis 10 , acute hepatitis 46,47,48 , viral
encephalitis 49,50,51,52 , measles 53 , mumps 54 , Herpes 55 ,, influenza 56 and rabies in guinea
pigs 57 . Also consistent with human case reports of influenza 18 , mononucleosis 58 ,
chikungunya 59 and Zika 60 in which intravenous vitamin C was utilized successfully as
therapy.
Recently, there is some global movement leaning towards including ascorbic acid as part of
the modalities used for the management of pulmonary failure due to the corona virus. One of
these is a randomized protocol recently approved by the National Institutes of Health using
12 grams of intravenous ascorbic acid for severe infected 2019-nCov pneumonia. This
research is led by Dr. ZhiYong Peng, Zhongnan Hospital in Wuhan, China 61 .
More recently another clinical study using 10 grams of iv AA for hospitalized patients With
COVID-19 started in Italy. This study lead by Salvatore Corrao, MD from the University of
Palermo started on March 13, 2020 62 .
3The Shanghai Expert Consensus on Covid-19 Treatment organized by the Shanghai
Medical Association has included ascorbic acid as a treatment modality for Cov-2019 virus
associated pneumonia 63 .
An International Pulmonologist’s Consensus Group has stated that a moderate dose of IV
vitamin C could be considered (e.g. 1.5 grams IV q6 ascorbic acid plus 200 mg thiamine IV
q12) for treatment of this disease and they consider this dose to be safe 64 .
On a presentation given to us by Dr. Enqian Mao, chief of Emergency Medicine Department
at Ruijin Hospital, Shanghai, affiliated with the Joatong University School of Medicine and a
member of the Senior Expert Team at the Shanghai Public Health Center and co-author of
the Shanghai Guidelines for the Treatment of Covid-19 infection, an official document
endorsed by the Shanghai Medical Association and the Shanghai city government he stated
65
:






In the year 2020, out of the 358 CoVid19 patients, 50 patients were treated with
intravenous ascorbic acid (IVAA)
Dose was 10-20 gm infused over 24 hours
A patient that continued to deteriorate received an increased dose of 50 gm of
ascorbic acid infused over a period of 4 hours and started responding during the
infusion. This patient had a complete recovery and was eventually discharged.
All patients receiving IVAA improved and there was zero mortality
No side effects
Patients who received IVAA had average 5 days shorter stay (from 30 to 25 days)
than untreated patients
Given the track record of safety of intravenous ascorbic acid 66 and the diversity of favorable
actions of ascorbate in the management of viral infections on sepsis and the effects on
diminishing inflammatory complications in the scientific and clinical literature we propose the
evaluation of high dose intravenous ascorbic acid infusions as a therapeutic intervention in
patients with severe acute respiratory infection from covid-19. We propose this study to
evaluate the clinical safety and efficacy of high dose intravenous vitamin C in the clinical
management of severe acute respiratory infection from covid-19.
Currently there are 3 ongoing clinical trials in CoVid19 patients using intravenous ascorbate
as treatment registered in clinicaltrials.gov and several others not registered yet. In addition
there are some that are in the process of being submitted for approval and funding before
starting. The clinical trial to be conducted in Puerto Rico is expected to submitted for IRB
approval very soon. This study will examine as primary outcome measures mortality
(survival), length of stay at the ICU and length of stay at the hospital. Secondary outcomes
will include severity scores, laboratory markers and others.
Here is a summary of the ongoing registered trials:
PI/ Location
Dose
Primary
4
Secondary1
2
3
4
5
6
Amount of patients
ZhiYong Peng, Zhongnan
Hospital of Wuhan
University, Wuhan, Hubei,
China 140 pts CoVid19
François Lamontagne,
Université de Sherbrooke
Quebec, Canada
800 pts CoVid19
Salvatore Corrao, MD,
University of Palermo, Italy
800 pts CoVid19
Wessam Adel El Sayed
Abdel Aziz El Driny, Ain
Shams University. Ventilator
Associated Pneumonia
( VAP) Sepsis
Virginia Commonwealth
University. Richmond,
Virginia, USA, Sepsis
Alcoholic Hepatitis
Emory University, University
of Kentucky, Cleveland
Clinic, NHLBI (CIRIS-ALI)
Acute lung injury (170)
12g Vitamin C/ sterile
water 50ml @ 12ml/h;
infusion 12h x 7 days
50 mg/kg (≈ 3.5 gm)
every 6 hours for 96
hrs.
(Aprox 14 gm/d)
10 gr/d of vitamin C
intravenously in
addition to
conventional therapy
1.5 gm intravenous
(IV) Vitamin C in 100
ml dextrose 5%
outcome
Ventilation-free
days outcome
Mortality, ICU
stay
Mortality at 28
days ICU stay
Mortality at 6
months
Mortality Hospital stay
Incidence of
Ventilator -
Associated
Pneumonia Plasma Vitamin
C level
Vitamin C (14 gm)
200mg/kg/24hours
dextrose 5%
50 mg/kg (≈ 3.5 gm)
every 6 hours for 96
hrs. in dextrose 5%
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5
mSOFA
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Enlaces para descargar estos dos documentos:
Proposal: https://app.blackhole.run/#1cd4259159188...PgQbgdV3su
Data Summary: https://app.blackhole.run/#19d8e70fa916R...R15hpGpn77
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