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Helped Needed for Potentially Life-Saving COVID-19 VNS Study

Helped Needed for Potentially Life-Saving COVID-19 VNS Study
April 8, 2020 Patrick Nemechek, D.O.

Dear Readers,

This is an open letter that I hope you will share with any clinicians you might know working on the front lines treating patients with COVID-19, also known as Coronavirus or SARS-CoV-2.

As the situation continues to decline globally with no viable treatment plan currently in effect, I would like to share my expertise to aid the treatment of COVID-19 using vagus nerve stimulation.  There is clinical evidence that vagus nerve stimulation can possibly alleviate the pro-inflammatory cytokine storm that appears to contribute to the death of many COVID-19 patients.

Right now medical communities need to come together to find a successful treatment for this pandemic and so I am asking you to please forward this letter to frontline physicians from any country who might be interested.  Encourage them to read the letter and contact me to discuss participating in the study.

A copy of the ‚ÄúDear Doctor‚ÄĚ letter and protocol are attached to this post.¬† Downloadable PDF versions can be found at:

Letter – https://www.nemechekconsultativemedicine.com/wp-content/uploads/VNS-ARDS-Prevention-Trial-Letter-1.pdf

Protocol Р https://www.nemechekconsultativemedicine.com/wp-content/uploads/COVID-19-VNS-ARDS-Prevention-Trial-1.1.2.pdf

Video – https://vimeo.com/user84994393/review/406018524/2d4ae6173b

 

Thank you,

Dr. Patrick Nemechek

 

Dear Doctor Letter

Dear Doctor,

My name is Dr. Patrick Nemechek, (Internal Medicine, UCLA) and I would like to thank you and your colleagues for your tremendous efforts towards helping those suffering during this pandemic.

In my 20 years’ experience as an HIV specialist, I witnessed patients undergoing treatment for advanced AIDS develop an immune reactivation syndrome that could result in ARDS with an excessive immunological response profile and ground-glass chest x-ray findings similar to patients with COVID-191,2,3.

My present research utilizes transcutaneous vagus nerve stimulation (tVNS) to suppress excessive inflammatory reactions and I have a supply of tVNS devices that I would like to donate towards a study of the treatment of COVID-19.

Five minutes of VNS is a very potent reducer of systemic pro-inflammatory cytokine levels and results in reduced joint pain in humans with rheumatoid arthritis as well as reduced mortality from septic shock in animals when exposed to intravenous LPS (a gram-negative bacteria molecule), polymicrobial challenge and septic peritonitis.4,5,6,7

I strongly believe that 5 minutes of tVNS administered 1-3 times per day has the potential to improve the clinical course of COVID-19 in hospitalized patients and may also prevent the deterioration of non-hospitalized patients.  As adjunctive therapy, VNS has a proven track record for safety and would not interfere with any other treatment regimen.

If successful, these devices can be made in large numbers and can be re-used from patient to patient after a simple sterilization process.  It has the potential to be an ideal treatment modality for healthcare systems struggling to successfully treat these patients.

I am in the process of seeking IRB approval for the study and hope to publish the findings as soon as possible.

A copy of the protocol is available at https://www.nemechekconsultativemedicine.com/wp-content/uploads/COVID-19-VNS-ARDS-Prevention-Trial-1.1.2.pdf.  A short video reviewing the impact of VNS on pro-inflammatory cytokines can be found at https://vimeo.com/user84994393/review/406018524/2d4ae6173b.

If you are even a little interested in this project, I encourage you to either e-mail me at [email protected] or call my office at +1-623-208-4226.

 

Respectfully,

Dr. Patrick Nemechek

 

References:

  1. Chen G et al. Clinical and immunologic features in severe and moderate Coronavirus Disease 2019. J Clin Invest. 2020 Mar 27. pii: 137244. doi: 10.1172/JCI137244.
  2. Zheng HY et al. Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients. Cell Mol Immunol. 2020 Mar 17. doi: 10.1038/s41423-020-0401-3.
  3. Mehta et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.
  4. Koopman FA et al. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis.¬†Proc Natl Acad Sci U S A. 2016;113(29):8284‚Äď8289. doi:10.1073/pnas.1605635113
  5. Zhao YX et al. Transcutaneous auricular vagus nerve stimulation protects endotoxemic rat from lipopolysaccharide-induced inflammation. Evid Based Complement Alternat Med. 2012;2012:627023. doi:10.1155/2012/627023
  6. van Westerloo DJ et al. The cholinergic anti-inflammatory pathway regulates the host response during septic peritonitis. J Infect Dis.2005 Jun 15;191(12):2138-48. Epub 2005 May 10.
  7. Huston JM et al. Transcutaneous vagus nerve stimulation reduces serum high mobility group box 1 levels and improves survival in murine sepsis. Crit Care Med. 2007 Dec;35(12):2762-8.

 

COVID-19 VNS ARDS Prevention Trial

Brief Study Description

The objective of this study is to determine the therapeutic effect and tolerance of transcutaneous vagus nerve stimulation in patients with moderate, severe or critical pneumonia associated with Coronavirus Disease 2019 (COVID-19).

The vagus nerve can be electrically stimulated with implantable or transcutaneous methods which significantly reduce of pro-inflammatory cytokines and improve clinical outcome in a variety of medical conditions including inflammatory bowel disease, rheumatoid arthritis and sepsis.

COVID-19 patients appear to have an excessive immunological response and ground-glass chest x-ray findings indicative of inflammatory damage to the lungs.¬† Transcutaneous vagus nerve stimulation suppresses excessive inflammatory reactions and may be useful in controlling the ‚Äúcytokine storm‚ÄĚ that is responsible for ARDS (Acute Respiratory Distress Syndrome) and¬† pulmonary failure observed in COVID-19.

The study will evaluate of 5 minutes of transcutaneous auricular vagus nerve stimulation (taVNS) delivered four times daily to hospitalized COVID-19 patients.

taVNS will be administered to consenting adult patients over 60 years of age hospitalized with COVID-19 and diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.  All study subjects will continue to also receive any treatment considered standard of care.

Patients who choose not to receive taVNS will receive standard of care. Outcomes of taVNS plus stand of care treated patients will be compared with outcomes of standard of care only treated patients.

Study Design 

Study Type  :Interventional  (Clinical Trial)
Estimated Enrollment  :100
Allocation:Non-Randomized
Intervention Model:Single Group Assignment
Intervention Model Description:Open label clinical trial
Masking:None (Open Label)
Primary Purpose:Treatment of COVID-19
Official Title:COVID-19 VNS ARDS Prevention Trial
Actual Study Start Date  :TBD
Estimated Primary Completion Date  :TBD
Estimated Study Completion Date  :TBD

 

Arms and Interventions

  1. Single arm, non-controlled, open label
  2. Transcutaneous auricular vagus nerve stimulation will be administered for 5 minutes every 6 hours. Electrical contact will be a specialized clip with one contact placed within the concha and the other contact of the clip acting as the grounding element on the back of the ear.
  3. Stimulation will be at 5-10 Hz, 500-800 mS at 10v or 5-10 Hz, 300 uS at 2.0 mA (depending on the type of stimulation device used).

  

Outcome Measures

Primary Outcome Measures  :

  1. Survival without need of mechanical ventilation at day 14. [  time frame: 14 days from symptom onset ]

Survival without need of mechanical ventilation (including non-invasive ventilation, NIV) at day 14 were to be considered a positive outcome. Patients in need of mechanical ventilator utilization (including non-invasive Ventilation, NVI), or death will be considered a negative outcome. New do not resuscitate (DNR) orders will be considered a negative event at the date of the DNR.

  1. WHO progression scale </=5 at day 4 [ time frame: 4 days ]

WHO progression scale:

  • 0 – Uninfected; no viral RNA detected
  • 1 – Asymptomatic; viral RNA detected
  • 2 – Symptomatic; independent
  • 3 – Symptomatic; assistance needed
  • 4 – Hospitalized; no oxygen therapy
  • 5 – Hospitalized; oxygen by mask or nasal prongs
  • 6 – Hospitalized; oxygen by NIV or High flow
  • 7 – Intubation and mechanical ventilation, pO2/FIO2>=150 or SpO2/FIO2>=200
  • 8 – Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) or vasopressors (norepinephrine >0.3 microg/kg/min)
  • 9 – Mechanical ventilation, pO2/FIO2<150 and vasopressors (norepinephrine >0.3 microg/kg/min), or Dialysis or ECMO
  • 10 – Dead
  1. Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48 h) at day 14 [ time frame: 14 days ]

Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48 h) at day 14. Death or DNR order will be considered a competing negative event.

  1. WHO progression scale </=7 at day 4 [ time frame: 4 days ]

 

Secondary Outcome Measures  :

  1. WHO progression scale [ time frame: 7 and 14 days ]
  1. WHO progression scale:\ rating
  1. Survival [ time frame: 14 days ]
    1. Overall survival
  2. 28-day ventilator free-days [ time frame: 28 days ]
    1. Number of days
  3. Respiratory Acidosis at day 4 [ time frame: 4 days ]
    1. Arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ‚Č•60 mm Hg for >6 hours
  4. time to oxygen supply independency [ time frame: 14 days ]
  1. Time to oxygen supply independency
  1. duration of hospitalization [ time frame: 28 days ]
  1. Duration of hospitalization
  1. time to ICU discharge [ time frame: 28 days ]
  1. Time to ICU discharge
  1. time to hospital discharge [ time frame: 28 days ]
  1. Time to hospital discharge

 

Criteria

Eligibility Criteria:

Ages Eligible for Study:60 Years and older
Sexes Eligible for Study:All
Accepts Healthy Volunteers:No

Inclusion Criteria:

  1. Patients requiring hospital admission with moderate to severe COVID-19 pneumonia and pneumopathy.
  2. Patients showing fever and respiratory symptoms with radiological findings of pneumonia.
  3. Respiratory distress (‚Čß30 breaths/ min);
  4. Oxygen saturation ‚ȧ93% at rest in ambient air; or oxygen saturation ‚ȧ97 % with O2 > 5L/min.
  5. PaO2/FiO2 ‚ȶ 300mmHg

Exclusion Criteria:

  1. Known intolerance to vagus nerve stimulation.
  2. Pregnancy

More Information

Responsible Party                                           Dr. Patrick M Nemechek, D.O.

Contact:¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬† +1-623-208-4226, [email protected]

 

 

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