Conditions: COVID-19
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity, weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls. The study to be done at Missouri State University is titled ( Two week sub-chronic double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray will reduce the symptoms, duration and replication of COVID-19 infection)

Detailed description:
Inhibition of Viral Replication, Reduction of the "Cytokine Storm" and reduction of COVID-19 symptoms- Potential Treatment and Preventative for COVID-19

In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the FDA, with Pulmonary Fibrosis, COPD and Cystic Fibrosis patients, inhaled sodium pyruvate reduced nasal and lung inflammation and congestion by reducing inflammatory cytokines including the IL-6 cytokine that causes the so-called cytokine storm with no known adverse reactions. Cellular Sciences received Orphan Drug Designations for Pulmonary Fibrosis and Cystic Fibrosis. Mice studies conducted by Dr. Lupfer at Missouri State University substantiated our finding by testing nebulized sodium pyruvate in flu (influenza A H1N1 virus) infected mice that decreased morbidity, weight loss, proinflammatory cytokines, and decreased viral titers (virus numbers) compared to the Placebo Control. Additionally, treated mice consumed more chow during infection indicating improved symptoms (same results reported in a pilot mice COVID-19 study). There were notable improvements in pro-inflammatory cytokine production (IL-1β) and lower virus titers (viral numbers) on days 7 post infection in mice treated with Sodium pyruvate compared to the Placebo Control animals. As pyruvate acts on the host immune response, metabolic pathways and not directly on the virus, our data demonstrate that sodium pyruvate is a promising treatment option that is safe, effective, and unlikely to elicit antiviral resistance. Furthermore, we have preliminary data that suggest it may work similarly during other respiratory virus infections including COVID19/SARS-CoV-2.

In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients, inhaled sodium pyruvate, a Non-Steroidal Nasal Spray (N115) demonstrated a statistically and clinically significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%), and a statistically and clinically significant reduction in coughing, hypoxemia and a reduction in nasal and lung inflammation. Inhaled sodium pyruvate alleviated the symptoms associated with the COVID-19 infections in Patients with COPD and Pulmonary Fibrosis. Nasal Nitric Oxide reduces the rate, duration and severity of viral infections in healthy young children and in healthy adults from the Flu, Rhinovirus and Coronavirus. The literature has reported that Nitric Oxide is elicited and inhibits viral replication in pigs infected with porcine respiratory coronavirus. Additionally Nasal Nitric Oxide levels decreases from normal levels found in healthy adults, in patients with asthma (87%), COPD (73%) CF (44%) and Primary Ciliary Dyskinesia (7%). The rate of infections increases with decreasing levels of nasal nitric oxide. Young children, 6-17 years of age, produce (142%) more nitric oxide than healthy adults, which may explain their resistance to COVID-19. Recently, researchers announced that a high percentage of COVID-19 infected patients that were hospitalized were Diabetics or were Pre-Diabetic. The literature has reported that elevated levels of glucose in patients with diabetes mellitus cause a deficiency in the production of nitric oxide by blunting nitric oxide synthesis, which may explain their susceptibility to COVID-19. Sodium pyruvate increases nitric oxide and is safe for use by Patients with Diabetes. The inhalation of nasal sodium pyruvate increased the synthesis of nasal nitric oxide to normal levels in patients with low levels of nitric oxide to increase all lung functions and decrease the rate of infections.

A clinical survey of 367 patients who took a nasal spray similar to EmphyCorp' s N115 formula, over a two-year period demonstrated a statistically significant decrease in the number, symptoms, and severity of seasonal flu respiratory tract infections. The number of flu or colds was reduced by 70% in Children and approximately 52% in Pregnant Women, Patients with Allergic Rhinitis, Diabetes, and Pulmonary Fibrosis. It has been used successfully by over 2 million patients globally in over 200 hospitals during the past 5 years to treat nasal and lung inflammation, congestion in Patients with COPD, Allergic Rhinitis, Pulmonary Fibrosis, sinusitis, the flu and Cystic Fibrosis, with no adverse events reported. It has been used by Children, Diabetics, and Hypertensives, with efficacy and with no known side effects. It has even been shown to be safe for use by Pregnant Women, for whom steroids are contraindicated as they increase the risk of low birth-weight babies.

Proactive treatments with sodium pyruvate are not toxic and could be of benefit to children that are afflicted by many respiratory viruses and as a potential treatment for COVID long haulers.

Arms:
arm 1: In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infection. arm 2: In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infection.

Interventions: intervention 1: Sodium Pyruvate intervention 2: Saline
Intervention descriptions: intervention 1: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days. intervention 2: Subjects will use a saline nasal spray 3x daily for 14 days.

Protocol document:
Prot_SAP_001.pdf: 
1 
 
 Cellular Sciences, Inc. 
84 Park Avenue, Atrium, Suite E-102, Flemington, NJ 08822 
Phone (908) 237-1561; Fax (908) 782-3819; E-Mail dr.martin@erols.com 
 
Two Week Sub-Chronic Double-Blinded, Placebo 
Controlled Trial Designed to Determine if Sodium 
Pyruvate Nasal Spray Will Reduce the Symptoms, 
Duration and Replication of COVID-19 and Influenza 
Infections.  
 
 
 
 
 
Research Facility 
Missouri State University 
Trinity Healthcare 
Dynamic DNA Labs 
Springfield, MO 
 
 
 
 
Sponsor 
EmphyCorp/Cellular Sciences, Inc. 
84 Park Avenue,·Atrium, Suite E-102, Flemington, NJ 08822 
Phone (908) 237-1561; Fax (908) 782-3819; E-Mail dr.martin@erols.com 
 
Current Date: 2/21/2021 
Current Version: CSI-COVID-19_007 
IND:50089 


2 
 
Signature Page 
 
Principal Investigator 
Name:  __Christopher Lupfer, Ph.D.________________ 
Signature: ___________________________ 
Date: ____12-18-2020_____________________ 
 
Co-Investigator 
Name: ____Rhy Norton___________________ 
Signature: ___________________________ 
Date: _______________________________ 
 
Sub-Investigator(s) 
Name: _________________________ 
Signature: ___________________________ 
Date: _______________________________ 
 
Clinical Coordinator 
Name:  __Dr. John Abraham, M.D.___________________________ 
Signature: ___________________________ 
Date: _______________________________ 
 
Clinical Monitor 
Name: __Ronald J. Amen, Ph.D._________ 
Signature: ___________________________ 
Date: _______________________________ 
 
Sponsor: 
Name: __Alain Martin, Ph.D.____________ 
Signature: ___________________________ 
Date: _______________________________ 


3 
 
1.0 A Statement of the Objectives and Purpose of the Study. 
1.1 
Introduction 
 
Inhibition of Viral Replication and Reduction of the “Cytokine Storm” with EmphyCorp’s 
Proprietary Compounds - Potential Treatment and Preventative for COVID-19 and Flu 
 
Flu and COVID-19 are known to cause mortality and morbidity in the elderly who are 
immunocompromised.       However, it is often forgotten that both diseases afflict children, usually with mild 
symptoms. In rare cases, there is mortality caused by complications during Flu infection.  
 
Since 2010, Flu has caused between 7,000-26,000 hospitalizations annually in children under five years 
old. Compared to that of COVID-19 which has accumulated a total of 3,240 hospitalizations in school-aged 
children. To date, 51 children, aged less than 18, have died in the United States from complications with 
COVID-19. Comparatively, the CDC has reported a range of 37-188 deaths annually in children under five 
years of age, from complications caused by the flu.  
 
Potential proactive treatments, such as N115 (sodium pyruvate), would be of benefit to all populations, 
especially children that are afflicted by both viruses. In both animal and human trials, N115 reduced viral 
titers (number of viruses), and reduced the number, symptoms, and severity of seasonal flu respiratory 
tract infections in pregnant women, children, diabetic, and patients with COPD by over 52% annually.  
 
In tissue culture studies, in human studies and in animal studies when inhaled or applied topically, sodium 
pyruvate inhibited the ability of many viral strains from replicating due to the ability of Sodium Pyruvate to 
increase the synthesis of Nitric Oxide that is needed to kill infections.  
 
Mice studies conducted by Dr. Lupfer at Missouri State University substantiated our finding by testing 
nebulized N115 in flu (influenza A H1N1 virus) infected mice that decreased morbidity, weight loss, 
proinflammatory cytokines, and decreased viral titers (virus numbers) compared to the Placebo Control. 
Additionally, treated mice consumed more chow during infection indicating improved symptoms (same 
results reported in a pilot mice COVID-19 study). There were notable improvements in pro-inflammatory 
cytokine production (IL-1β) and lower virus titers (viral numbers) on days 7 post infection in mice treated 
with Sodium pyruvate compared to the Placebo Control animals. As pyruvate acts on the host immune 
response, metabolic pathways and not directly on the virus, our data demonstrate that sodium pyruvate is 
a promising treatment option that is safe, effective, and unlikely to elicit antiviral resistance.  
 
Furthermore, they stated “we have preliminary data that suggest it may work similarly during other 
respiratory virus infections including COVID19/SARS-CoV-2. Proactive treatments with sodium pyruvate is 
not toxic and could be of benefit to children that are afflicted by many respiratory viruses”.     
 
Sodium Pyruvate Ameliorates Influenza A Virus Infection In Vivo - Online Research Posting on 
BioRxiv: 
https://www.biorxiv.org/content/10.1101/2020.11.25.396978v1  
 
A clinical survey of 367 patients over a two-year period demonstrated a statically significant decrease in 
the number, symptoms, and severity of seasonal Flu respiratory tract infections after using the 20mM 
sodium pyruvate nasal spray (EmphyCorp, N115).  The number of flu or colds was reduced by 70% in 
Children and approximately 52% in Pregnant Women, Patients with Allergic Rhinitis, Diabetes, and 
Pulmonary Fibrosis. 
 
In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the FDA, with Pulmonary 
Fibrosis, COPD and Cystic Fibrosis patients, N115 reduced nasal and lung inflammation and congestion 
by reducing inflammatory cytokines including the IL-6 cytokine that causes the so-called cytokine storm 
with no known adverse reactions. 
 
In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients, N115 Non-
Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in Nasal Nitric Oxide, 
FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and a significant reduction in coughing, nasal and 
lung inflammation. N115 alleviated the symptoms associated with the COVID-19 infections in 
Patients with COPD and Pulmonary Fibrosis. 


4 
 
EmphyCorp has treated over 3 million Patients globally in 200 hospitals with no adverse events and has  
17 human clinical trials that have been submitted to the FDA to support our NDA Phase III marketing 
application. Over a million patients in that group were patients with allergic rhinitis and as stated by the 
FDA 24% of their symptoms were caused by nasal infections predominantly colds and flu.  
 
 
1.1.2 Background and Product Description 
N115 is a sodium-pyruvate-based inhalation drug. It has been administered via several 
routes including intravenous, topical administration for hyperkeratotic disorders, and as an 
enteral supplementation since it is considered GRAS (Generally Regarded as Safe) by the FDA. 
Sodium pyruvate is used in many products including (Neosporin, Lubriderm, vaginal products, 
Viva Eye Drops, Ringers Solution, human IV solutions, and solutions to store red blood cells by 
the Red Cross, and to store human organs for transplant). Sodium pyruvate has been shown to 
protect neurons, lungs, hearts, muscles, cerebral metabolism, embryos, eyes, kidneys, cellular 
DNA and membranes from oxygen radical damage. Other approved uses in patients with a 
variety of medical disorders include Friedreich’s disorder; and it is used as a therapeutic solution 
in open heart surgery, kidney surgery, and eye surgery.  
Six different nasal spray formula combinations were tested for safety and efficacy in a 
series of studies with subjects who normally use nasal sprays. The sodium pyruvate 
concentrations were 5mM, 10mM, 20mM and 40mM. The sodium pyruvate was delivered in 
sterile sodium chloride solutions of either 0.45% or 0.90%. All formulas reduced inflammation 
in the nasal cavities and otherwise improved the nasal cellular morphology. There weren’t any 
adverse events observed.  
Additionally, safety and efficacy were tested for four weeks in patients with pulmonary 
fibrosis (PF), where it was determined that there was proven efficacy in reducing the conditions 
of PF, while no adverse events were reported. In a Phase III Placebo Controlled Clinical Trial 
with Idiopathic Pulmonary Fibrosis Patients, N115 demonstrated a statistically and clinically 
significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and a significant 
reduction in coughing, nasal inflammation, and congestion. Nasal inflammation and congestion 
block the release of nasal nitric oxide. Blockage of nitric oxide increases the rate and severity of 
infections.  In our human Phase II/III Placebo Controlled Clinical Trials, N115 reduced nasal 
congestion and inflammation. In additional six human clinical trials with COPD patients 
submitted to the FDA, N115 demonstrated a significant decrease in nasal and lung inflammation, 
substantial increases in lung functions, and increased nitric oxide needed to kill invading bacteria 
and viruses.  These are critical benefits for treating the symptoms of Covid-19, as lung 
inflammation leads to pneumonia and death. Improving lung function of Covid-19 patients can 
save lives. Increased nasal nitric oxide is a preventative to reduce the rate, duration and spread of 
the disease.  
1.2 History of N115 Drug Use 
N115 is all-natural, non-steroidal, and has no known side effects. It has been used 
successfully by over 2 million patients globally in over 200 hospitals during the past 5 years to 
treat nasal and lung inflammation, congestion in Patients with COPD, Allergic Rhinitis, 
Pulmonary Fibrosis, and Cystic Fibrosis.  It has been used in Children, Diabetics, and 
Hypertensives, with efficacy and with no known side effects.  It has even been shown to be safe 


5 
 
for use by Pregnant Women, for whom steroids are contraindicated as they increase the risk of 
low birth-weight babies.  
 
 
1.3 Mechanism of Action 
The upper and lower airways form one contiguous and functionally related organ that is critical 
to normal lung functions. The nasal cavity produces 900-1,100 parts per billion of nitric oxide, 
which is used to kill invading bacteria, fungi, and viruses, compared to the lungs which produce 
4-48 parts per billion nitric oxide. Nasal nitric oxide is a natural defense against disease. In 
recent clinical studies, Nitric oxide is elicited and inhibits viral replication in pigs infected with 
porcine respiratory coronavirus. Nasal nitric oxide also produces clinically useful 
bronchodilation and has been shown to reduce pulmonary fibrosis. Blockage of nasal nitric oxide 
by inflammation or congestion, reduces the amount of nitric oxide reaching the lungs, which 
reduces critical lung functions, leading to increased lung and nasal infections, a reduced SaO2 
level, reduced FEV-1 levels also leading to mouth breathing and coughing.  Nasal nitric oxide is 
also essential because it 1) increases oxygenation in your blood by inhaling more nitric oxide, 
which is a vasodilator and bronchodilator that increases oxygen transport throughout the body.  
2) Warms, moistens and filters the air.  3)Traps particles in nose hairs and mucous membranes.  
4) Helps reduce the likelihood of developing colds, flu, allergies, and irritating cough.  5) 
Prevents nasal dryness. 6) Helps relieve stress and calm the body as it slows breathing.  7) 
Promotes healthy digestion. 8) reduces risks of developing snoring or sleep apnea. Nasal steroids 
and other OTC nasal treatments shut down the synthesis of nasal nitric oxide, which then leads to 
decreased lung functions and a 34% increase in infections.  
As cited in hundreds of peer reviewed publications, naturally occurring nitric oxide in the 
nasal cavities is a primary defense in humans; it is needed to kill invading bacteria, fungi and 
viruses. Nasal nitric oxide also prevents and reduces the rate and severity of viral infections, 
viral replication from Rhinoviruses, the Flu, and Coronavirus.  
Nitric oxide decreases significantly from the normal levels found in young healthy adults 
when compared to patients with Asthma, COPD, Diabetes, Cystic Fibrosis, and Primary Ciliary 
Dyskinesia. The rate of infection increases with decreasing levels of nasal nitric oxide.  
1.4 Nasal nitric oxide and COVID-19 infections. 
Nasal Nitric Oxide reduces the rate, duration and severity of viral infections in healthy 
young children and in healthy adults from the Flu, Rhinovirus and Coronavirus. It’s been 
demonstrated that Nitric oxide is elicited and inhibits viral replication in pigs infected with 
porcine respiratory coronavirus. Nasal Nitric Oxide levels decreases from normal levels found in 
healthy adults, in patients with asthma (87%), COPD (73%) CF (44%) and Primary Ciliary 
Dyskinesia (7%). The rate of infections increases with decreasing levels of nasal nitric oxide. 
Young children, 6-17 years of age, produce (142%) more nitric oxide than healthy adults, which 
may explain their resistance to COVID-19. Recently, researchers announced that a high 
percentage of COVID-19 infected patients that were hospitalized were Diabetics or were Pre-
Diabetic. The literature has reported that elevated levels of glucose in patients with diabetes 
mellitus cause a deficiency in the production of nitric oxide by blunting nitric oxide synthesis, 


6 
 
which may explain their susceptibility to COVID-19. N115 increases nitric oxide and is safe for 
use by Patients with Diabetes. 
As cited in hundreds of peer reviewed publications, naturally occurring nitric oxide in 
the nasal cavities is a primary defense in humans. Nitric Oxide is needed to kill invading 
bacteria, fungi and viruses, and prevents/reduces the rate, duration and severity of viral 
infections, viral replication from the Common Cold, Rhinoviruses, the Flu, and Coronavirus. 
N115 Increases Nasal Nitric Oxide thus is a preventative to reduce the rate and spread of the 
disease.  
 Most Diabetic, Hypertensives, Pulmonary Fibrosis and Cystic Fibrosis Patients have 
very low nasal nitric oxide which makes them more susceptible to viruses and lung infections. 
The rate of infection increases with decreasing levels of Nasal Nitric Oxide making them more 
susceptible to all infections including COVID-19. Elevated levels of glucose in patients with 
diabetes mellitus cause a deficiency in the production of nitric oxide by blunting nitric oxide 
synthesis, which may explain why diabetics have a high susceptibility to COVID-19.  
2.0 COVID-19 and flu Infection.  
COVID-19 and flu can be understood by the region of the lung that is infected. Mild disease will 
be confined to the conducting airways and severe disease will involve the gas exchange portion 
of the lung. Both flu and COVID-19 are a major health concern and can be devastating, 
especially for the elderly. COVID-19 is the disease caused by SARS-CoV2 the virus. Although 
much is known about the mortality of the clinical disease, much less is known about its 
pathobiology. Although details of the cellular responses to this virus are just emerging, a 
probable course of events can be postulated based on past studies with SARS-CoV. Based on the 
cells that are infected, COVID-19 can be divided into three phases that correspond to different 
clinical stages of the disease. Stage #1: Asymptomatic state (Initial 1–2 days of infection); Stage 
#2: Upper airway and conducting airway response (Next few days), and, Stage #3 Hypoxia, 
ground glass infiltrates, and progression to ARDS. Flu can also result in a descending, 
progressive disease resulting in pneumonia and ARDS in severe cases.  
 
Purpose and Objectives of the Studies. 
A COVID-19 Non-Steroidal Nasal Spray Treatment and Preventative that can get athletes, 
students and the general population, that test positive for Covid-19,   back playing and back to work  
much faster than a 14-day quarantine and as a Preventative to help reduce the rate, duration and 
spread of the virus, is critical to the world.  In testing patients with the saliva/sputum test developed 
by Yale University, it was discovered that some actively infected patients may be asymptomatic, but 
remain infected, in some cases for three weeks or longer. Thousands of data points have been 
collected with the saliva/sputum tests on the duration of the infection in COVID-19 patients. This 
data will be used as a historical baseline to demonstrate a reduction and duration of the infection in 
patients that use the N115 nasal spray.    
This will be an on-going trial that will study the effects of a 20mM sodium pyruvate in 0.9% 
sodium chloride nasal spray solution on COVID-19 viral infections of patients with proven COVID-
19 infections.  
1. Nasal-pharyngeal swabs that are currently FDA approved for testing COVID-19 patients, 
will be used to determine if an individual is actively infected.  


7 
 
2. Covid-19 positive individuals will receive the nasal spray that will be used three times 
per day. This spray will be placebo control (15 patients, 0.9% sodium chloride with 
0.02% benzalkonium chloride) or N115 treatment (15 patients, 20mM sodium pyruvate 
in 0.9% sodium chloride with 0.02% benzalkonium chloride). Study staff and subjects 
will be blinded.  
3. Patients will return for testing again every other day to determine how fast the nasal spray 
reduces the viral load and infection, compared to the viral loads and infection on Day 
Zero, historical baselines, and placebo.  
EmphyCorp Rx N115 Non-Steroidal Nasal Spray increases nasal nitric oxide and has the 
potential of reducing the rate and spread of COVID-19 among healthy individuals, diabetics, and 
others. Nasal steroids and other OTC nasal treatments shut down the synthesis of nasal nitric oxide 
which increases the rate of infections. This would indicate that the use of EmphyCorp’s Rx N115 
Nasal Spray by healthy individuals including Adults, Children, Pregnant Women, and Diabetics that 
are currently infected with COVID-19 without other underlying health conditions, could reduce the 
rate, duration and spread of infection.   
 
3.0 Mechanism of Action of N115 
Sodium pyruvate is a natural antioxidant, and as an antioxidant has been shown to 
significantly reduce inflammatory agents throughout the human body including the lungs and 
nasal passages. The reduction of inflammatory agents including IL-6 the cause of the cytokine 
storm in COVID-19 patients. Nasal congestion does not allow nitric oxide to be produced by 
nasal cells and released into the nasal cavities. A previous study with Pulmonary Fibrosis 
patients clearly demonstrated a significant increase in exhaled nitric oxide, and since nitric oxide 
has been shown to kill virus, including COVID-19, this trial is being designed to determine if the 
N115 Sodium pyruvate-based nasal spray will i increase in nasal nitric oxide to the extent that 
COVID-19 viral loads are reduced or eliminated. 
In over six human clinical trials submitted to the FDA, with pulmonary fibrosis, COPD 
and Cystic fibrosis patients, N115 reduced lung inflammation by reducing inflammatory 
cytokines including the IL-6 cytokine that causes the so-called cytokine storm in COVID-19 
patients and did this with no known adverse reactions. 
In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients, 
N115 Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase 
in Nasal Nitric Oxide, FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and a significant 
reduction in coughing, nasal and lung inflammation. N115 increases Oxygen by reducing 
hypoxemia, and it also reduces lung inflammation, inflammatory cytokines, and coughing. These 
are critical benefits for treating the symptoms of Covid-19, as lung inflammation leads to 
pneumonia and death. 
 
4.0 Pre-Clinical and Clinical History and Studies 
4.1 
Pre-Clinical Experience and Studies 
As part of Cellular Science’s IND submissions, five animal studies were conducted with 
solutions of differing concentrations of sodium pyruvate. These included a "Maximum Tolerated 
Nose Dose" study in rabbits (2000X the therapeutic human dose) and a 180-day nose only 


8 
 
inhalation study in which rats were exposed to 100 times the sodium pyruvate level expected to 
be administered to humans. No product related adverse reactions were observed or reported in 
any animal study, and the drug regimens were judged to be safe as determined by the FDA.  
Rat studies in which the effect of multiple intratracheal administrations of sodium 
pyruvate on lung injury caused by bleomycin were conducted. Two weeks after the bleomycin 
insult, there was a significant (p<0.01) reduction in total cells found in the bronchoalveolar 
lavage containing sodium pyruvate, compared to the sodium chloride control, indicating a 
reduction in airway inflammation. It was concluded that sodium pyruvate was effective in 
reducing inflammation and lung damage in this chronic fibrotic stage of lung injury. (It should 
be noted that this type of injury with subsequent fibrotic infiltration is typical of the fibrosing 
group of interstitial diseases in humans including COVID-19.) 
 
 
5.0. 
Qualifications of the Principal Investigator.  
Dr. Lupfer has 15 years experience studying respiratory pathogens, developing antiviral drugs 
and vaccines, and studying the immune response to respiratory pathogens. Dr. Lupfer has 
designed the trial and will analyze final clinical data. Dr. Abraham is a clinician and will head 
the clinical research and data collection. 
 
Identification of the Research Facility  
5.1. Research Facilities  
Missouri State University in collaboration with Trinity Healthcare and Dynamic DNA 
labs in Springfield Missouri. 
 
 
5.2. Institutional Review Board 
 
5.3 Study Objectives 
Primary Objective 
a. The primary objective is to evaluate the effects of inhaled nasal sodium pyruvate 
(N115) in patients with confirmed COVID-19 or flu infections by determining 
changes in the duration of an active infection by PCR from nasal. 
Secondary Objective 
a. The second objective is to evaluate the ability of the inhaled nasal sodium pyruvate 
therapy in subjects with COVID-19 or flu infections to improve symptoms by the use 
of a patient diary and by collecting periodic vital signs, especially body temperature, 
blood pressure and pulse/Ox. 
5.4. 
Study Design Overview 
Individuals that are symptomatic for COVID19/influenza will initially be tested by Dynamic 
DNA Labs or Trinity Healthcare (Screening Visit). If positive for COVID19/influenza, patient 
will then be solicited for participation in the trial within 24 hours. After signing Informed 
Consent, women of child-bearing age will provide a urine sample to test for pregnancy. They 
will be randomly assigned to either the placebo or drug groups in a double blinded fashion and 
be given a data logbook, or clinical app for their phone, in which they will record the number of 
coughs and other flu-like symptoms they experience each day. Patients will be contacted by 
phone and/or sent reminders through a clinical phone app every two days to review symptoms 
and protocol compliance and patients will be tested via nasal swab every other day. This will 
continue every other day until the subject tests negative for COVID-19/ influenza (which is 


9 
 
defined as a 2-Log reduction in virus titer or less than 1000 copies of viral RNA) or 14 days, 
whichever comes first. Personnel collecting swabs will wear N95 mask and face shield, 
disposable examination gloves and disposable gown while collecting nasal swabs from patients. 
Samples will be collected outdoors, weather permitting, or in a well ventilated room in inclement 
weather. 
 
 
 
 
6.0. 
The criteria for patient selection and for exclusion of patients, and an estimate of the 
number of patients to be studied. 
6.1. 
Subject Selection 
6.1.1 Number of Patients to be Studied 
Fifteen patients with confirmed COVID-19 infection will be enrolled in the trial 
in the drug group and fifteen with confirmed COVID-19 infection will be enrolled 
in the trial in the placebo group. An additional fifteen patients with confirmed 
influenza infection will be enrolled in the trial in the drug group and fifteen with 
confirmed influenza infection will be enrolled in the trial in the placebo group. 
Efforts will be made to include women and minorities. The study will be double 
blinded to subjects and study investigators.  
6.2. 
Inclusion Criteria 
6.2.1. Individuals with a confirmed COVID-19/influenza viral infection, as determined 
by a qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for 
COVID19 or rapid flu test from nasal swab for influenza.    
6.2.2. Individuals who agree to abstain from sexual intercourse, or agree to use condoms 
or vaginal diaphragms or other devices designed to prevent contraception, during 
the entire course of the study 
6.3. 
Exclusion Criteria 
6.3.1. Viral infections other than COVID-19 or influenza. 
6.3.2. Clinically significant cardiac disease including uncontrolled congestive heart 
failure and unstable angina 
6.3.3. Pregnancy 
6.3.4. Females of child bearing potential age not on adequate contraception or lactating 
6.3.5. Subjects receiving systemic corticosteroid treatment within one month of 
Screening Visit 
6.3.6. Subjects Less than 18 years of age 
6.3.7. Hospitalization within last 6 months due to acute exacerbation of airway disease 
6.3.8. Subjects with a clinically significant abnormal chest x-ray within past 12 months 
6.3.9. Medication changes within one month of study entry 
6.3.10. Subjects who have participated in another investigation drug treatment study 
within the previous month. 
6.3.11. Subjects with a current history of alcohol or recreational drug abuse. 
6.3.12. Subjects who have taken dietary supplements containing pyruvate within 24 hours 
prior to the screening visit.  
6.4 Inclusion of Women and Minorities 


10 
 
Every attempt will be made to include all genders, and minorities that present with an active 
COVID-19 or flu infection that are not exempted due to exclusion criteria. 
 
7.0. 
A Description Of The Design Of The Study, Including The Kind Of Control Group 
To Be Used, If Any, And A Description Of Methods To Be Used To Minimize Bias On 
The Part Of Subjects, Investigators, And Analysts. 
7.1. 
Assignment Of Subject Number And Randomization 
This is a placebo controlled double blinded trial. Upon enrollment, each subject will be 
sequentially issued a unique subject number starting at 100. Once a number has been 
assigned to a subject, it cannot be re-assigned to another subject. Subjects will be encouraged 
to complete the study, although they may withdraw at any time without prejudice. 
Termination will be reported to the sponsor in a timely manner. Details of the reason(s) why 
a subject is dropped from the study will be documented. Enrollment will continue until the 
number of subjects specified in the protocol has been attained. The data from all subjects that 
have been given a study compound will be retained for analysis. 
7.2. 
Randomization 
The subjects will be randomized to the placebo control or N115 drug study groups. 
 
7.3. 
Study Design 
7.3.1. Pre-study Visit 
A pre-study visit will occur and the eligibility of the subject for inclusion determined. 
COVID19 or influenza positive patients will sign an Informed Consent (paper or eConsent), and 
a list of current medications will be taken. Urine samples from child-bearing aged women will be 
collected and analyzed for pregnancy (or last menstrual cycle recorded). During this visit, any 
flu-like symptoms will be noted, temperature, Pulse/Ox and blood pressure will also be 
measured. During this pre-study visit, the patients are to continue with their normal therapy, if 
any. 
7.3.2. Study Visit 1 
Only COVID19 or influenza single positive subjects meeting enrollment criteria will be 
enrolled after review of health information collected in the pre-study visit. The correct use of the 
N115 sodium pyruvate nasal spray will be demonstrated to COVID-19 or influenza infected 
subjects, and the subjects that have been confirmed to have an infection will administer their first 
dose while monitored in the clinic or via telehealth. (Nasal spray can be delivered to patient at 
time of telehealth visit by currier). The patients will be told to spray each nostril three times, 
three times per day: morning, mid-day, and evening. Patients will also be instructed on filling out 
the Daily Data Log form or in the use of the clinical symptoms app, which will be used to record 
administration of the drug doses, any flu-like symptoms, and any perceived adverse events.  
7.3.3 Study Visit 2 etc. 
At home or on-site follow-up visits will occur every two days after Study Visit 1. During this 
visit, a nasal swab will be taken to determine if the patient still has an active infection. 
Temperature, Pulse/Ox and blood pressure will also be examined during these visits. Study 
monitors will review the Daily Data Log form/ Clinical app and compliance with study protocol 
of N115 administration will be reviewed. If needed, additional bottles of N115 nasal spray will 


11 
 
be delivered to the patient in the clinic or via currier.  
This process of testing every two days will continue until the particular subject proves to be 
virus free (2 Log or greater decrease in viral RNA or less than 1000 viral RNA copies) or 14 
days, whichever is first. When the patient is virus free, he/she will be excused from the study. If 
the subject is virus free, they will be asked to provide a second nasal swab within 24 hours to 
verify the negative result. 
 
 
7.3.4 Telephone Communication 
Subjects will be instructed to call the clinic should they be experiencing any self-perceived 
adverse events, or if they have any study-related questions. All telephone information will be 
documented.  
7.3.5. Products Description (How Administered) 
The product is an all-natural patented 20 mM sodium pyruvate in 0.9% sodium chloride nasal 
spray solution with 0.02% benzalkonium chloride as a preservative. The plastic bottle contains 
30 mL. It is non-steroidal. Patients will forcibly expel air from their lungs and then will 
administer three sprays per nostril while inhaling strongly so that the drug is transported through 
the nose and into the lungs. The drug is to be administered three times per day (morning, mid-
day, and evening). The product comes with instructions for administration (three sprays per 
nostril).  
7.4 Concomitant Therapy 
No concomitant therapy is prescribed for this study, but the subjects may continue to use their 
normal therapy as long as they list it as a current medication. The Principal Investigator may 
prescribe “rescue medication” should it be required by any of the patients. Patients may continue 
taking nutritional supplements. safety. Subjects may not use any of the following during the trial 
or for one week before enrollment in the trial: all intranasal medications or lavages, 
antihistamines, steroids or anti-inflammatory medications of any kind. Subjects also may not 
currently be taking any antiviral or antibiotic medications. 
 
8.0. 
The Method For Determining The Dose(S) To Be Administered, The Planned 
Maximum Dosage, And The Duration Of Individual Patient Exposure To The Drug. 
This is a constant dose study. The amount of delivered sodium pyruvate was determined in 
clinical trials to be three sprays of 20 mM sodium pyruvate in 0.9% sodium chloride solution per 
nostril, and this is repeated 3x per day (morning, midday, and evening). The dose was 
determined by evaluating the data from both animal and human studies (cited above).  
 
9.0. 
A Description Of The Observations And Measurements To Be Made To Fulfill The 
Objectives Of The Study. 
Observations for safety will include a pregnancy test for women of child-bearing age, 
blood oximetry, and vital signs. 
Observations for efficacy will include evaluation of sore throat, congestion, erythema, the 
number of daily coughs, and flu-like symptoms. Perceived adverse events will be 
monitored. 
Premature Withdrawal 


12 
 
The patients can withdraw from the study at any time, and for any reason. All data collected 
from these patients will be analyzed. Reasons for withdrawal will be recorded to ensure that it 
was not due to an adverse event. 
 
8.2 Testing Schedule-Sub-Chronic Phase of COVID-19 or flu positive patients 
Test 
Pre-study 
visit 
Day 0 
Visit 1 
Day 2  Day 4 
Day 6 
Day 8, 
etc. 
Clinic Visit or 
telehealth check 
 
+ 
+ 
+ 
+ 
+ 
Informed Consent 
+ 
 
 
 
 
 
Medical History 
+ 
+ 
 
 
 
 
Physical Exam/ 
+ 
 
 
 
 
 
Observe 
Administer Drug 
 
+ 
+ 
 
 
 
Pregnancy Test 
for Females 
+ 
 
 
 
 
 
Concurrent 
Medications 
Reviewed 
+ 
+ 
+ 
+ 
+ 
+  
Symptom Data 
Logbook (Clin. 
App.) 
 
+ 
+ 
+ 
+ 
+ 
Adverse Events 
Reviewed 
 
+ 
+ 
+ 
+ 
+ 
Nasal Swab for 
virus titer 
 
+ 
+ 
+ 
+ 
+ 
 
12.0 
Safety Testing 
12.1 
Physical Exam 
12.2 
Efficacy Tests 
12.2.1 Nasal swab test for COVID-19 or influenza virus analyzed by qPCR. 
 
13.0 
A description of clinical procedures, laboratory tests, or other measures to be taken 
to monitor the effects of the drug in human subjects and to minimize risk 
Tests and analyses will be conducted every other day during the study. If any aberrant values 
occur, the Clinical Coordinator will determine if that patient should continue the study or be 
removed. All aberrant values that occur during the study will be considered adverse events. 
 
14.0. Safety Precautions Included in this Study: 
The 20 mM nasal sodium pyruvate inhalation has been administered to both healthy humans and 
humans with lung diseases, without the occurrence of any SAE.  
• First administration of nasal spray monitored via telehealth on in clinic. 
• The initial nasal spray will be administered under the supervision of medical staff.  


13 
 
• 
If a subject develops any adverse event during the follow-up period after study drug 
administration, the subject will be treated to a satisfactory resolution before being 
discharged from the clinic. 
• Subjects will remain in contact via telehealth or in the clinic for 30 minutes after the 
initial inhalation of the nasal spray.  
• Follow up telephone communications, as needed. 
• If at any time the patient shows severe signs of disease or complications, they shall be 
removed from the study by the physician (Dr. Abraham) and treated using proven 
methods for COVID19 or flu. These include, but are not limited to, antiviral drugs 
(Tamiflu, remdesivir, etc.), convalescent serum, oxygen and critical care. Treatment 
decisions will be made by Dr. Abraham, the patient’s physician or an emergency care 
physician as needed. The patient may also withdraw from the study at any time, and for 
any reason, and seek traditional standard of care for COVID19 or flu. 
• Severe signs of disease or complications include abnormal blood pressure (low or high), 
resting blood O2 below 90%, apnea, fever over 103° F, altered mental state, impaired 
renal function, hemorrhaging or other severe symptoms. 
 
15.0 Product Evaluation Questionnaire. This information will not be collected in the current 
study as it has been collected in numerous prior studies. 
 
16.0 
Daily Data Logbook:  
Subjects will use this diary card or a clinical phone app to record the number of their coughs 
per day and flu-like symptoms, any self-perceived adverse events, and any medication 
changes during the study. 
 
17.0 Urinalysis: Samples may be taken and analyzed to determine if any females of child 
bearing age are pregnant 
 
18.0 Study Management 
18.1 
Case Report Forms 
Case Report Forms (CRF) will be supplied by Cellular Sciences and the testing facility. Data will 
be recorded in the CRFs according to the following: 
Instructions to data entry personnel and Monitor:  
(a)Explain all missing data and include reference to any original data that is not contained in the 
study file. If a space is blank because the item was not done, mark the item “N/A”. If the item is 
not applicable to the individual case, mark the item "N/A”. If an item is unknown, mark the 
space “UNK". Legibly write or print all entries in black ink. If an entry error has been made, 
draw a single straight line through the wrong entry and enter the correct data above it. Please 
initial and date all such changes. DO NOT ERASE OR OPAQUE OUT ERRORS. For 
clarification of illegible or uncertain entries, print the clarification above the item, then initial and 
date the clarification. 
18.2. Data Collection, Management, and Statistical Analysis 
The data management staff at the research clinic and lab (Trinity Healthcare and Dynamic 
DNA Labs) will collect and manage the data. Monitoring and auditing of the data will be 


14 
 
conducted by a staff member of Cellular Sciences remotely.  
The basic statistical analysis will be repeated measurements of Analysis of Variance using 
baseline measurements as a covariant per subject. Group comparisons of N115 to placebo will be 
analyzed by ANOVA followed by Chi Square, Fisher Exact, and other appropriate significance 
tests. Data will be compared to placebo controls and current publicly available matched data and 
observed values compared. Time dependence in viral titer reduction will also be compared.  Dr. 
Lupfer will be responsible for the statistical analysis. Analysis will be performed blinded.   
18.3. Study Monitoring 
A Study Monitor who will be responsible for auditing data will be appointed by Cellular 
Sciences. The Monitor will visit the clinical site two or three times during the trial to assure that 
all data are being collected and that the Case Report Forms are completed and correctly filled 
out. Alternatively, virtual visits may be conducted due to COVID19 exposure concerns. 
18.4. Data from Patients Who Withdraw from the Study 
If a subject withdraws from a study, the data collected on the subject to the point of 
withdrawal will remain part of the study database and will not be removed.  
The investigator may ask a subject who is withdrawing whether the subject wishes to provide 
continued follow-up and further data collection subsequent to their withdrawal from the 
interventional portion of the study. Under this circumstance, the discussion with the subject 
would distinguish between study-related interventions and continued follow-up of associated 
clinical outcome information, such as medical course or laboratory results obtained through non-
invasive chart review and address the maintenance of privacy and confidentiality of the subject’s 
information.  
If a subject withdraws from the interventional portion of the study but agrees to continued 
follow-up of associated clinical outcome information as described in the previous bullet, the 
investigator must obtain the subject’s informed consent for this limited participation in the study 
(assuming such a situation was not described in the original informed consent form). In 
accordance with FDA regulations, IRB approval of informed consent documents would be 
required (21 CFR 50.25, 56.109(b), 312.60, 312.66, 812.100).  
If a subject withdraws from the interventional portion of a study and does not consent to 
continued follow-up of associated clinical outcome information, the investigator must not access 
for purposes related to the study the subject’s medical record or other confidential records 
requiring the subject’s consent. However, an investigator may review study data related to the 
subject collected prior to the subject’s withdrawal from the study, and may consult public 
records, such as those establishing survival status.  
18.5. Product Packaging 
The product packaging has complied with FDA regulations. The nasal spray will be contained in 
a sterile plastic vial that can be squeezed to administer the correct dosage. The packaging meets 
21CFR312.6 including the statement "New Drug - investigational use only." The vials necessary 
for each study period (i.e. ~14 days) will be placed in a plastic bag with the patient’s number.  
18.6. Product Storage Requirements 
18.6.1 At Research Center 
The products are to be stored at room temperature, but not above 85oF 
18.6.2 In Home 


15 
 
The products are to be stored at room temperature, but not above 85oF 
18.7. Record Retention 
All records will be kept by the clinic for a period of three years. After that, they will be sent to 
Cellular Sciences. 
18.8. Additional Studies 
No additional studies are planned at this time. 
 
19.0 
Reports on Adverse Events 
19.1 
Definition of an Adverse Event 
CTCAE term (Adverse event description) and grade: The descriptions and grading scales found 
in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will 
be utilized for adverse event reporting.  All appropriate treatment areas should have access to a 
copy of the CTCAE version 3.0.  A copy of the CTCAE version 3.0 can be downloaded from the 
CTEP web site (http://ctep.cancer.gov/reporting/ctc.html). 
 
“Expectedness”:  Adverse events can be “Expected” or unexpected.  
Attribution of the adverse event (Section 4.8.5): 
Definite – The adverse event is clearly related to the study treatment. 
Probable – The adverse event is likely related to the study treatment. 
Possible – The adverse event may be related to the study treatment. 
Unlikely – The adverse event is doubtfully related to the study treatment. 
Unrelated – The adverse event is clearly NOT related to the study treatment. 
A serious adverse event (SAE) is defined as any expected or unexpected adverse event (AE, 
generally equivalent to CTCAE ver 3.0 grades 3, 4 or 5) that is related or unrelated to the 
intervention that results in any of the following outcomes: 
 
• Death 
• A life-threatening event 
• In-patient hospitalization (not required as part of the treatment) or 
prolongation of existing hospitalization 
• A persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
• Causes cancer 
• Is an overdose 
 
Certain medical events that may not result in death, be life-threatening, or require 
hospitalization, may also be considered a serious adverse event when appropriate medical or 
surgical intervention is necessary to prevent one of the outcomes listed above. 
Unexpected Adverse Event - Any event in which the severity or specificity is not consistent 
with the risk information described in the protocol, and the event is not anticipated from the 
subject's disease history or status. 
Expected Adverse Event - Any event in which the severity or specificity is consistent with 


16 
 
the risk information described in the protocol or is anticipated based on the subject's medical 
history. 
Important medical events that may not be immediately life-threatening or that do not result in 
death or hospitalization may be considered SAEs when, on the basis of appropriate medical 
judgment, they may jeopardize the patient and may require medical or surgical intervention to 
prevent one of the outcomes listed above. 
All deaths, regardless of cause, must be reported for patients on study and for deaths 
occurring within 30 days of last study drug dose. 
19.2. Examples of Adverse Events 
• Inter-current illnesses 
• Injuries 
• New symptomatology (this does not include symptoms expected as a result of the 
subject’s condition unless it is beyond what is normally expected) 
• Significant laboratory abnormalities 
• New abnormal physical exam findings 
• Significant exacerbation of pre-existing conditions 
19.3. Recording and Documentation of Adverse Events 
Any adverse event (i.e., a new adverse event or an exacerbation of a pre-existing condition) 
with an onset date after study drug administration should be recorded as an adverse event on the 
Case Report Form (CRF). All adverse events must be recorded on the appropriate CRF 
regardless of the severity or relationship to study medication. 
An adverse event or laboratory abnormality with an onset date before study drug 
administration is considered to be pre-existing in nature. These pre-existing events, will be noted 
in the CRFs. 
All SAEs occurring during this study, whether observed by the physician, nurse, or reported 
by the patient, will be recorded on the Florida Advanced Medical Research Adverse Events form  
19.4 
Investigator Report of a "Serious Adverse Event" to Cellular Sciences 
Cellular Sciences (Sponsor) must be notified immediately regarding the occurrence of any SAE 
that occurs after the first dose of study drug has been administered. The procedures for reporting 
SAEs are as follows: 
• Complete the “Serious Adverse Event Report.” 
• Email the SAE Report to Cellular Sciences (see below) within 24 hours of the 
investigator’s knowledge of the event. 
• These preliminary reports must be followed by detailed descriptions that include copies 
of hospital case reports, autopsy reports, and other documents when requested and 
applicable. 
• The contact information for reporting SAEs is as follows:  
Following the first dose of the drug product, the Investigator or designee must report the 
occurrence of any serious adverse event to Cellular Sciences within one (1) business day, 
regardless of the causal assessment to study medication. A photocopy or facsimile of the Serious 
Adverse Event page of the CRF must be provided to: 
Ronald J. Amen, Ph.D. 
 
 
 
 
 
Alain Martin, Ph.D. 


17 
 
Director 
 
 
 
 
 
 
 
Director 
Cellular Sciences  
 
 
 
 
 
Cellular Sciences 
18101 Catherine Circle 
 
 
 
 
 
84 Park Ave 
Villa Park, CA 92861 
 
 
 
 
 
Flemington, NJ 08822 
ronald.amen@techenterprises.org 
 
 
 
dr.martin@erols.com 
19.5 
IRB Notification 
The Investigator is responsible for promptly notifying the Institutional Review Board of all 
serious adverse events and providing appropriate documentation. The Investigator should notify 
the IRB as soon as is practical. Notification should be in writing where this is required by local 
regulatory authorities and in accordance with the local institutional policy. 
Adverse events must be reported to the Investigator and IRB according to definitions and 
guidelines at http://www.infosci.coh.org/ocrqa/forms/guidance.doc and which are defined herein. 
AEs will be monitored by the PMT. Less than serious adverse events will be reported only at the 
time of protocol continuation reports. 
Cellular Sciences may request additional information from the Investigator to ensure the 
timely completion of accurate safety reports. 
19.6   Attribution 
For reporting purposes, attribution is the assessment of the likelihood that an AE is caused by 
the research agent or protocol intervention.  The attribution is assigned by the treating 
physician/Principal Investigator after considering the clinical information, the medical history of 
the subject, and past experience with the research agent/intervention.  This is recorded using the 
Adverse Event Report (COH AER) form (http://resadmin.coh.org/doc /irb3820.doc) in one of 
five categories scored as the following: 5=related, 4=probably related, 3=possibly related, 
2=unlikely related, and 1=unrelated.  
19.7. Post-study Adverse Events 
The Investigator will notify Cellular Sciences of any serious adverse event he/she becomes 
aware of that occurs at any time after a subject has completed study participation, if in the 
Investigator’s judgment the event may be reasonably related to the medication used in the study. 
The Investigator will follow the subject until the adverse event resolves or becomes stable. 


18 
 
20.0 
References 
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33. Van MJ. Manen, Surinder S. Birring, Carlo Vancheri, Vincent Cottin, Elisabetta A. Renzoni, Anne-Marie Russell, 
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35. Mattes, K. et al. NO in exhaled air is correlated with markers of eosinophilic airway inflammation in 
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42. Comhair, S. et al. Rapid loss of superoxide dismutase activity during antigen-induced asthmatic response.  
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57. Robertson, FM, Gene expression and cellular sources of inducible nitric oxide synthase during tumor 
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58. Soler MN, et al, Gene therapy of rat medullary thyroid cancer by naked nitric oxide synthase II DNA 
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20 
 
64. M. Yoshida et al. The effect of low dose inhalation of nitric oxide in patients with pulmonary Fibrosis, Eur 
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65. Yong GL et al. Outpatient inhaled nitric oxide in a patient with idiopathic pulmonary fibrosis: a bridge to 
lung transplant. J Heart lung transplant 2001 Nov; 20(11): 1224 7 
66. Ian M Balfour-Lynn et al Reduced upper airway nitric oxide in cystic fibrosis Archives of diseases in 
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67. Ferguson E et al. Changes in nasal nitric oxide concentrations associated with symptoms of common cold 
and treatment with topical decongestants. Acta Otolaryngology 1997 Jul; 117(4); 614-7    
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437-44 
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Otorhinolaryngol head neck surg (chian) vol 31 iss 2 p102-109  
       70. Baraldi E. et al. Effect of topical steroids on nasal nitric oxide production in children with perennial allergic. 

ICF_000.pdf: 
Cellular Sciences, Inc. / Emphycorp / Protocol Number Pro00049340 
Page 1 of 9   
 
 
 
Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
RESEARCH SUBJECT CONSENT FORM 
AND AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH 
INFORMATION  
 
Sponsor / Study Title: 
  
Cellular Sciences, Inc. / Emphycorp / “Two Week Sub-
Chronic Double-Blinded, Placebo Controlled Trial Designed 
to Determine if Sodium Pyruvate Nasal Spray Will Reduce 
the Symptoms, Duration and Replication of COVID-19 and 
Influenza Infections.” 
Protocol Number: 
 
Pro00049340 
 
Principal Investigator: 
(Study Investigator) 
 
Christopher Lupfer, PhD 
 
Telephone: 
 
(417) 521-3925 
(908) 399- 3426 (24 Hours) 
 
Address: 
Dynamic DNA Labs 
2144 E Republic Rd B204 
Springfield, MO    65804 
 
Trinity Healthcare 
2740 N Mayfair Ave 
Springfield, MO    65803 
 
 
 
You are being invited to take part in a research study. A person who takes part in a research 
study is called a research subject, or research participant. 
 
1. This consent is being sought for research. 
2. Participation in this research study is voluntary. 
3. The duration of this study will be no longer than three hours on the first day, and then 
30 minutes every other day for up to 14 days. 
4. The purpose of this research is to evaluate the ability of N115 to reduce viral titers (the 
number of virus particles) and symptoms in COVID-19 or influenza (flu) infected 
subjects.  
5. You will be given a medical exam, and instructions. These are tests that do not cause 
any pain. 
 
What should I know about this research? 
• Someone will explain this research to you. 
• This form sums up that explanation. 
• Taking part in this research is voluntary. Whether you take part is up to you. 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
• You can choose not to take part. There will be no penalty or loss of benefits to which you 
are otherwise entitled. 
• You can agree to take part and later change your mind. There will be no penalty or loss of 
benefits to which you are otherwise entitled. 
• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
 
Why is this research being done? 
The purpose of this research is to study the effects of N115, a natural antioxidant of the human 
body that has been used to treat millions of patients with sinus and lung diseases, to determine if 
this study drug can reduce the severity, duration and symptoms of COVID-19 or the flu. This 
study drug is believed to also have the ability to improve lung function and nasal inflammation in 
subjects with a COVID-19 or flu infection.  The study drug is investigational and has not been 
approved by United States Food and Drug Administration (FDA). It has not previously been 
studied for the treatment of COVID-19 or influenza. 
 
About 60 subjects will take part in this research, 30 with COVID-19 and 30 with the flu. 
 
How long will I be in this research? 
We expect that your taking part in this research will last approximately three hours on the first 
day and then 30 minutes every other day for up to two weeks (14 days). 
 
If a subject withdraws from the study, the data collected on the subject to the point of withdrawal 
will remain part of the study database and will not be removed.  
 
The investigator may ask a subject who is withdrawing whether the subject wishes to provide 
continued follow-up and further data collection subsequent to their withdrawal from the 
interventional portion of the study. Under this circumstance, the discussion with the subject 
would distinguish between study-related interventions and continued follow-up of associated 
clinical outcome information, such as medical course or laboratory results obtained through non-
invasive chart review and address the maintenance of privacy and confidentiality of the subject’s 
information.  
 
If a subject withdraws from the interventional portion of the study but agrees to continued 
follow-up of associated clinical outcome information as described in the previous paragraph, the 
investigator must obtain the subject’s informed consent for this limited participation in the study. 
 
If a subject withdraws from the interventional portion of a study and does not consent to 
continued follow-up of associated clinical outcome information, the investigator must not access 
for purposes related to the study the subject’s medical record or other confidential records 
requiring the subject’s consent. However, an investigator may review study data related to the 
subject collected prior to the subject’s withdrawal from the study, and may consult public 
records, such as those establishing survival status. 
 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
What happens to me if I agree to take part in this research? 
• You will be evaluated by a study investigator to see if you are healthy enough to 
participate. During this visit, any flu-like symptoms will be noted, and your temperature, 
vital signs and blood pressure will be taken. The study investigator will ask about current 
medications you are taking. 
• If you are a woman of child-bearing age, a urine sample will be collected and analyzed 
for pregnancy. You cannot participate in this study if you are pregnant. 
• You will be put into a study group by chance (like a coin toss). One study group will 
receive N115 study drug, the other study group will receive a placebo, which is a 
medically inactive substance. You have a 50% chance of being placed in each group. You 
cannot choose your study group. You and the study investigator will not know into which 
study group you have been assigned. 
• You will be provided with the N115 study drug, which is a nasal spray, or the placebo 
nasal spray, which is salt water, and asked to use the spray 3 times each day for up to 14 
days. 
• Every other day, you will need to meet with a study physician’s assistant to perform a 
nasal swab to determine if you still have COVID-19 or the flu and to get your vital signs 
checked. 
• You will be given a “Subject Diary” in which you will be asked to record your body 
temperature and symptoms like headache, nausea, vomiting, muscle aches, tiredness. If 
you do not have a thermometer, we will provide one without charge. 
• At this time, the study drug will not be available for sale, nor will it be available at the 
end of the study.  
• Follow-up studies are not planned at this time. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research: 
• You should be truthful about your health with the study investigator enrolling you in the 
study. You must not participate in the study if you have used any of the following in the 
last week or plan to use them for the next two weeks: all nasal spray medications, 
nebulized medications or lavages, all antihistamines, steroids or anti-inflammatory 
medications of any kind. Subjects also may not currently be taking any antiviral or 
antibiotic medications. 
• You should not participate in this research if you have any of the following: 
1. An infection other than COVID-19 or influenza. 
2. Clinically significant cardiac disease including uncontrolled congestive heart 
failure and unstable angina. 
3. Pregnancy. 
4. Females of childbearing potential age not on adequate contraception or lactating. 
5. Subjects less than 18 years of age. 
6. Hospitalization within last 6 months due to acute exacerbation of airway disease 
like asthma. 
7. Subjects with a clinically significant abnormal chest x-ray within past 12 months. 
8. Medication changes within one month of study entry. 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
9. Subjects who have participated in another investigation drug treatment study 
within the previous month. 
10. Subjects with a current history of alcohol or recreational drug abuse. 
11. Subjects who have taken dietary supplements containing pyruvate within 24 hours 
prior to the screening visit.  
• The only drugs to be administered are the N115 nasal spray and the placebo nasal spray. 
• Aside from visiting the study investigator, you must continue to quarantine yourself to 
limit contact with others and reduce the spread of COVID19 and the flu. This study drug 
has not been proven to work, so taking it does not mean that you are better, and you must 
not leave quarantine. You need to continue to follow CDC guidelines, including 14-day 
quarantine. 
• Any self-perceived side effects should be immediately reported to the investigator. 
• You must agree to abstain from sexual intercourse, or agree to use condoms or vaginal 
diaphragms or other devices designed to prevent conception, during the entire course of 
the study. 
 
Could being in this research hurt me? 
• Any experimental drug study has potential risks. In addition to these risks, taking part in 
this research may harm you in unknown ways. You will also be placed in a random group 
and could receive the study drug N115 or the placebo salt water. The placebo means that 
you will not be receiving any treatment and the sickness may last longer. 
• To date, no side effects have been reported with the use of Sodium Pyruvate 
• The research data will be coded before it is shared with individuals outside of the 
research. However, there is a small risk of a breach of confidentiality.  
• You should seek urgent medical care if you experience significant worsening of your 
symptoms. 
 
Will it cost me money to take part in this research? 
• It will not cost you any out-of-pocket money to take part in this research. Your insurance 
may be billed if you require any emergency treatment. Any out-of-pocket economic 
expenditures that may occur as a result of a serious drug-related side-affect will be paid 
for by Cellular Sciences, Inc. (the study sponsor). 
 
Alternatives to treatment: 
You are in no way required to participate in this research study. There are FDA approved 
treatments for both COVID19 and the flu. If you are not interested in participating in this study, 
your study investigator can discuss other treatment options. 
 
Will being in this research benefit me? 
We cannot promise any benefits to you or others from your taking part in this research. If you 
receive the study drug and it is effective, possible benefits to you include improved lung 
function, allowing you to breath more easily, increased oxygen in your blood, allowing you to 
have more energy; and reduced nasal inflammation which may lead to reduced coughing and 
nasal pain and a reduction of the severity, duration and symptoms of COVID-19 or flu.  
 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
What happens to the information collected for this research? 
Your private information and your medical record will be shared with individuals and 
organizations that conduct or watch over this research, including: 
• The research Sponsor. 
• People who work with the research sponsor. 
• Government agencies, such as the Food and Drug Administration. 
• The Institutional Review Board (IRB) that reviewed this research. 
 
We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 
 
We protect your information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 
 
Data or specimens collected in this research might be deidentified and used for future research or 
distributed to another investigator for future research without your consent. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns or complaints about the study, please contact the study investigator at 
the telephone number listed on the first page of this consent document. If you seek emergency 
care, or hospitalization is required, alert the treating physician that you are participating in this 
research study.  
 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research subjects. If you have any questions about your rights as a research subject, 
and/or concerns or complaints regarding this research study, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00049340. 
 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
What if I am injured because of taking part in this research? 
If you are injured or get sick because of being in this research, call the study investigator 
immediately. The study investigator will provide emergency medical treatment. Your insurance 
may be billed for this treatment. The sponsor will pay any charges that are not covered by an 
insurance policy or the government, provided the injury was not due to your underlying illness or 
condition and was not caused by you or some other third party. No other payment is routinely 
available from the study investigator or sponsor. 
 
To pay medical expenses, the sponsor will need to know some information about you like your 
name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has 
to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.  
 
A new public health declaration, called the Public Readiness and Emergency Preparedness 
Declaration (PREP), was issued by the Department of Health and Human Services on March 10, 
2020.  This declaration limits the legal rights of a subject participating in a COVID-19 clinical 
study that uses a drug, device or vaccine designed to treat, diagnose, cure or prevent COVID-19. 
This includes the study drug N115 sodium pyruvate nasal spray used in this study.  Subjects 
using N115 sodium pyruvate nasal spray in this study will have limits on their right to sue the 
manufacturers, the study sponsor, healthcare providers and others for significant injuries and 
adverse reactions. 
 
Can I be removed from this research without my approval? 
The person in charge of this research can remove you from this research without your approval. 
Possible reasons for removal include: 
• It is in your best interest. 
• You have a side effect that requires stopping the research. 
• You need a treatment not allowed in this research. 
• You become pregnant. 
• The research is canceled by the FDA or the sponsor. 
• You are unable to take the study drug. 
• You are unable to keep your scheduled appointments. 
• If tests suggest a condition that would adversely affect the outcome of the study. 
 
We will tell you about any new information that may affect your health, welfare, or choice to 
stay in this research. 
 
What happens if I agree to be in this research, but I change my mind later? 
You may choose to leave the study at any time without any consequences and without any risks. 
If you decide to leave this research, contact the study team so that the investigator can arrange 
for you to come to the clinic or have a Telehealth visit for a final exam and review of your 
documentation.   
 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
Will I be paid for taking part in this research? 
Cellular Sciences, Inc. will pay each subject at the following rates: 
 
Visit 
Subject Payment Rate 
First Visit 
$50 
Final Visit 
$50 
 
This payment is for the subject. Subjects will be paid for the first and final visit, without regard 
as to whether the subject completes the entire study. Subjects will be paid at the end of their 
participation in the research study. 
 
Statement of Consent:  
I have read and understand the information in this informed consent document. I have had an 
opportunity to ask questions and all of my questions have been answered to my satisfaction. I 
voluntarily agree to participate in this study until I decide otherwise. I do not give up any of my 
legal rights by signing and dating this consent document. I will receive a copy of this signed and 
dated consent document. 
 
 
________________________________________ 
Subject’s Printed Name  
 
 
________________________________________  
___________  
Subject’s Signature 
 
 
 
 
 
Date 
 
 
________________________________________ 
Printed Name of the Person Conducting the 
Consent Discussion   
 
 
________________________________________  
___________ 
Signature of the Person Conducting the  
 
 
Date 
Consent Discussion 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH 
INFORMATION 
 
If you decide to be in this study, the study investigator and study staff will use and share health 
data about you to conduct the study. Health data may include: 
• Your name. 
• Address. 
• Phone number. 
• Date of birth. 
• Medical history. 
• Information from your study visits, including all test results.  
 
Health data may come from your study records or from existing records kept by your doctor or 
other health care workers.  
 
For this study, the study staff may share health data about you with authorized users. Authorized 
users may include: 
• Representatives of Cellular Sciences, Inc./Emphycorp. 
• Representatives of Missouri State University. 
• Representatives of Advarra IRB (an Institutional Review Board that reviews this study). 
• The Food and Drug Administration (FDA) and other US federal and state agencies. 
• Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be 
reported. 
• Governmental agencies of other countries. 
• Outside individuals and companies, such as laboratories and data storage companies, that 
work with the researchers and sponsor and need to access your information to conduct 
this study. 
• Other research doctors and medical centers participating in this study, if applicable.  
• A data safety monitoring board which oversees this study, if applicable. 
 
Your health data will be used to conduct and oversee the research, including for instance: 
• To see if the study drug works and is safe. 
• To compare the study drug to other drugs. 
• For other research activities related to the study drug. 
 
Once your health data has been shared with authorized users, it may no longer be protected by 
federal privacy law and could possibly be used or disclosed in ways other than those listed here.  
 
Your permission to use and share health data about you will end in 50 years unless you revoke it 
(take it back) sooner.  
 


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Christopher Lupfer, PhD 
Advarra IRB Approved Version 9 Feb 2021 
 
 
You may revoke (take back) your permission to use and share health data about you at any time 
by writing to the study investigator at the address listed on the first page of this form. If you do 
this, you will not be able to stay in this study. No new health data that identifies you will be 
gathered after your written request is received. However, health data about you that has already 
been gathered may still be used and given to others as described in this form.  
 
Your right to access your health data in the study records will be suspended during the study to 
keep from changing the study results. When the study is over, you can access your study health 
data. 
 
If you decide not to sign and date this form, you will not be able to take part in the study. 
 
STATEMENT OF AUTHORIZATION 
I have read this form and its contents were explained. My questions have been answered. I 
voluntarily agree to allow study staff to collect, use and share my health data as specified in this 
form. I will receive a signed and dated copy of this form for my records. I am not giving up any 
of my legal rights by signing and dating this form.  
 
 
__________________________________ 
Printed Name of Subject 
 
 
__________________________________  
 
__________ 
Signature of Subject  
 
 
 
 
Date