The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol
Phase: PHASE2
Conditions: CoVid 19 Positive
Sponsor: The Camelot Foundation

 
 
 
 
The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol. 
 
 
 
1Richard M. Fleming, PhD, MD, JD (ORCID 0000-0001-9964-1518) 
 
1Matthew R. Fleming, BS, NRP 
 
 
 
 
1FHHI-OI-The Camelot Foundation 
Los Angeles, CA, USA 
 
 
 
Running title: The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol. 
 
 
 
 
Address all correspondence to: 
Richard M. Fleming, PhD, MD, JD 
DrRichardMFleming@gmail.com 
 
 
Key words: Fleming, FMTVDM, CoVid-19 Pneumonia (CVP) 
 
 
Protocol Date: 15 April 2020* 
 
 
CLINICAL TRIALS.GOV IDENTIFIER: *NCT04349410 
 
PROTOCOL MODIFICATION 4 JULY 2020 TO BE FOLLOWED AND PLACED IN 
APPENDIX G. 

TABLE OF CONTENTS…………………………………………………..………….i-ii 
 
ABSTRACT ……………………………………………………………………………………..….1 
 
FMTVDM DIRECTED COVID-19 PNEUMONIA (CVP) TREATMENT PROTOCOL…………..……1-17 
 
SIMPLIFIED EXPLANATION OF FMTVDM………………………………………………..………2-3 
 
FMTVDM COVID-19 PNEUMONIA TREATMENT PROTOCOL………………………………….3-14 
 
A. PROPOSED AEROSOLIZED AND INTRAVENOUS ADMINISTRATION OF ALL POSSIBLE 
MEDICATIONS…………………………………………………………………………..3-4 
 
B. PROPOSED TREATMENT REGIMENS. [TREATMENT CONSISTS OF THREE COMPONENTS: (1) 
ONE OF THE 10 TREATMENTS LISTED BELOW, (2) THE IMMUNE SUPPORTIVE TREATMENT, 
AND (3) ATROVENT NEBULIZER TREATMENTS.]……………………………………….5-8 
 
 
TREATMENT COMPONENT ONE………………………………………………………….5-7 
 
 
TREATMENT COMPONENT TWO……………………………………………………………7 
 
 
TREATMENT COMPONENT THREE………………………………………………………….8 
 
 
VENTILATOR SETTINGS…………………………………………………………………….8 
 
C. FMTVDM MEASUREMENT OF THE EXTENT OF DISEASE AND DETERMINATION OF 
TREATMENT RESPONSE………………………………………………………………...8-9 
 
D. SEQUENCE OF FMTVDM TESTING THROUGH COVID-19 DIAGNOSIS & TREATMENT…9-10 
 
 
FMTVDM MEASURED OUTCOMES OF TREATMENT……………………………………..10 
 
 
SCENARIO 1: IMPROVEMENT………………………………………………………….….10 
 
SCENARIO 2: DETERIORATION……………………………………………………….…..10 
 
SCENARIO 3: NO CHANGE…………………………………………………………….….10 
 
SUMMARY OF FMTVDM PATENT RIGHTS #9566037………………………………………..10-11 
 
SUMMARY OF THE TREATMENT PROTOCOLS FOR COVID-19…………………………….………12 
 
REFERENCES…………………………………………………………………………………13-14 
 
TABLE 1. CHARACTERISTICS OF DIAGNOSTIC IMAGING…………………………………………..15 
 
FIGURE 1. FMTVDM QUANTITATIVE MEASUREMENT ALONG THE HEALTH-SPECTRUM………….16 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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FIGURES 2. FMTVDM QUANTIFICATION OF PULMONARY TISSUE…………………………….17-18 
 
 
APPENDIX A. FMTVDM CALIBRATION AND IMAGING PROTOCOLS……………………….…..19-34 
 
 
STEP 1A: CALIBRATION OF PLANAR AND SPECT/CT SYSTEMS………………………...20-23 
 
 
 
STEP 1B: CALIBRATION OF PET SYSTEMS……………………………………………24-26 
 
 
STEP 2A: FMTVDM PLANAR OR SPECT/CT IMAGING PROTOCOL…………………………..27 
 
 
STEP 2B: FMTVDM PET IMAGING PROTOCOL……………………………………….28-29 
 
 
STEP 3: PATIENT COVID-19 FMTVDM MEASUREMENT AND MEANING OF RESULTS……30-34 
 
 
STEP 4: DELIVERY OF RESULTS TO NUCLEAR MEDICINE, PATIENT CHART & DR FLEMING…34 
 
 
APPENDIX 
B. 
TABLES 
FOR 
COLLECTING, 
RECORDING 
AND 
CALCULATING 
CAMERA 
 
CALIBRATION…………………………………………………………………………35-43 
 
 
APPENDIX B1: FOR PLANAR AND SPECT/CT FMTVDM QUANTITATIVE CALIBRATION…...36-39 
 
 
APPENDIX B2: FOR PET FMTVDM QUANTITATIVE CALIBRATION………………………..40-43 
 
 
APPENDIX C. FMTVDM INDIVIDUAL PATIENT DATA FORMS……………………………………..44-53 
 
 
FMTVDM PLANAR OR SPECT/CT REPORT FORM……………………………………….46-49 
 
 
FMTVDM PET REPORT FORM………………………………………………………….50-53 
 
 
APPENDIX D. CUMULATIVE INDIVIDUAL PATIENT SERIAL FMTVDM PATIENT DATA………………54-57 
 
 
APPENDIX E. SCHEMATIC OF FINAL PROTOCOL SEQUENCE……..…………………………….58-59 
 
APPENDIX F. FLEMING UNIFIED THEORY OF VASCULAR DISEASE (THE INFLAMMATION AND HEART 
 
DISEASE THEORY) EXPLAINS CRS & INCREASED BLOOD CLOTTING………..……….60-65 
 
 
APPENDIX G. FLEMING FMTVDM TREATMENT PROTOCOL EFFECTIVE 4 JULY 2020………66-67

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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ABSTRACT 
 
 
Diagnostic determination of disease and treatment responses has been limited 
to qualitative imaging, measurement of serum markers of disease, and sampling of 
tissue. In each of these instances, there is a built in error either due to sensitivity and 
specificity issues, clinician interpretation of results, or acceptance of the use of an 
indirect marker (blood test) of what is happening elsewhere in the body – at the tissue 
level.  
 
 
The Fleming Method for Tissue and Vascular Differentiation and Metabolism 
(FMTVDM) using same state single or sequential quantification comparisons [1] 
provides the first and only patented test (#9566037) - along with the associated 
submitted patent applications ruled to be covered under #9566037 - that quantitatively 
measures changes in tissue resulting from inter alia a disease process. This includes 
inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes 
including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood 
flow differences (RBFDs) caused by these diseases.  
 
 
The purpose of this paper is to make clinicians and researchers aware of this 
proposed method for investigating the prevalence and severity of CVP - in addition to 
providing rapid determination of treatment response in each patient, directing 
treatment decisions; thereby reducing the loss of time, money, resources and patient 
lives. 
 
FMTVDM Directed CoVid-19 Pneumonia (CVP) Treatment Protocol 
 
 
The major reason for fear and panic is the absence of a treatment that works for 
CoVid-19 pneumonia. 
 
 
We don't know what works because we have no treatment information.  
 
 
Everyone is scrambling to propose their ideas but the proposed studies have 
nothing to demonstrate treatment outcomes short of patients living or dying. We need 
to define outcomes long before that. 
 
 
 
By this we specifically mean, there is no proposal for showing what these 
treatments are doing at the tissue level - the lungs - during treatment and absent this 
information we are left with clinical changes only. 
 
 
FMTVDM is the only patented method, which can quantitatively measure where 
the patient is and the result of their treatment.  
 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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SIMPLIFIED EXPLANATION OF FMTVDM [1]. 
 
 
FMTVDM quantitatively measures changes in tissue – including inflammatory 
and infectious states and place people on a continuum [2] as shown in Figure 1. The 
critical differences between qualitative, semi-quantitative and quantitative FMTVDM are 
shown in Table 1 [2]. Examples of measurements taken in both pulmonary and cardiac 
tissue are shown in Figure 2. 
 
FMTVDM [1-6] – See Appendix A. 
  
1) Quantitatively calibrates the nuclear camera to guarantee that the measurements 
made by the camera are accurate, consistent and reproducible. This quantification is 
dependent upon the isotope being used, the camera and the timing sequence of image 
acquisition. Such calibration is NOT currently done and it is part of the patent. Studies 
have demonstrated that the lack of this quantitative calibration has resulted in up to 1/3 
of the data being lost for SUV and qualitative interpretation; in addition to making 
quantification impossible [6]. 
  
2) The patient presents in a fasting state - to eliminate digestive processes from 
interfering with blood flow distributions - and the differences in metabolic and regional 
blood flow differences (RBFDs) are enhanced with vasodilatory agents, shifting blood 
flow and isotope towards regions of greater blood flow and metabolism; enhancing 
isotope delivery, uptake and quantification. 
  
3) With a now quantitatively calibrated nuclear camera – in this instance a PLANAR 
camera – or SPECT/CT or PET/CT/MRI if specifically approved1 - to allow imaging to 
be done at patient’s bedside reducing the use of hospital resources required for 
transport and decrease potential for patient complications resulting from a transport - 
image acquisition will occur for 10-minutes following peak enhancement effect of the 
vasodilatory agent and timed injection of the isotope based upon the enhancing agent.  
 
 
Regions-of-interest (ROIs) will drawn by the nuclear technologist – either at the 
bedside or in the nuclear laboratory – to provide FMTVDM measurements using 
software already present in the nuclear camera systems. Specific ROIs will be drawn of 
the right lung (total), left lung (total), mediastinum (thymus activity), and any specific 
areas where increased tracer uptake is noted [7].  
  
4) These FMTVDM measurements including MAXIMAL COUNTS +/- VARIANCE, provide the 
values of the most active pulmonary tissue resulting from the CoVid-19 infection and 
inflammatory response; just as it has previously been used for CAD and Cancer.   
  
5) From these FMTVDM measurements, the pulmonary tissue and the CoVid-19 
infectious process results are placed on a Health-Spectrum showing where in the 
                                                
1 Specific details including imaging times and quantification change as noted in the protocol. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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tissue transitioning process the patient is [2]. The measurements also provide 
information about how rapidly the tissue is changing [1]. FMTVDM provides the 
quantitative measurement of where the patient is at any point in time during their 
course of treatment and how they compare with other patients. 
  
6) Once the FMTVDM measurements have been obtained, treatment decisions can be 
made based upon serial changes in FMTVDM. Treatments outcomes are based upon 
FMTVDM measurements, including the maximum FMTVDM and the variance in those 
measurements [1]. By comparing serial FMTVDM results, improvement or deterioration 
in the patient’s health and the success or failure of the current treatment regimen is 
measured, providing patient-centered, patient-specific, patient-oriented and patient-
directed decisions. Thus saving time, money, resources and lives - not to mention 
unnecessary side effects from treatment, which is not working. 
 
I. FMTVDM COVID-19 PNEUMONIA TREATMENT PROTOCOL: 
 
 
Patients who screen positive by PCR who require admission to the hospital will 
undergo FMTVDM testing immediately prior to initiation of treatment. If patients have 
already initiated treatment, FMTVDM will be useful to assess the status of the patient 
moving forward.  
 
 
Following FMTVDM treatment will be started and patients will undergo standard 
monitoring and supportive care in addition to the selection of the following treatment 
options noted below. 
 
A. PROPOSED AEROSOLIZED AND INTRAVENOUS ADMINISTRATION OF ALL POSSIBLE 
MEDICATIONS. 
 
 
In 2001, anthrax terrorism, introduced multiple people to a bacillus (Bacillus 
anthracis), which had endospores. The physicians who successfully treated their 
patients did so by recognizing they were dealing with an endospore species of 
bacterial. The combined medical treatment of ciprofloxacin, doxycycline and 
clindamycin – to varying degrees – proved effective because they targeted a specific 
component of the bacillus; the endospore. 
 
 
It is clear that the medications, which have been proposed for treating CoVid-19 
pneumonia – inter alia chloroquine, hydroxychloroquine, remdesivir – target the specific 
features of transcription and translation; obvious viral targets.  
 
 
When the first author was an Intern, he helped treat the oldest known living 
cystic fibrosis patient. The patient came to the hospital every 6-8 weeks and required 
antibiotic treatment. That treatment was an experimental aerosolized ciprofloxacin. 
Only by delivering the ciprofloxacin directly into his lungs, was the antibiotic able to 
achieve satisfactory tissue levels to address his pneumonia. 
 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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The lungs of CoVid-19 patients appear to exhibit the same type of significant 
reductions in function as our cystic fibrosis patient. Resulting both from localized 
pneumonia (CVP) and associated acute respiratory distress syndrome (ARDS) resulting 
from this inflammatory process [3,7]. 
 
 
Azithromycin, one of the proposed treatments, which like all macrolide 
antibiotics, works by inhibiting ribosomal translation of protein synthesis. Azithromycin 
is available in the aerosolized form. 
 
 
Each and every medication delivered for the purpose of treating the CoVid-19 
virus patient should be delivered via aerosol to obtain maximum pulmonary tissue 
penetration. Those drugs, which cannot be given by aerosol, should be given 
intravenously when possible; with oral delivery being the final alternative for giving 
medications, which cannot be delivered by aerosol or intravenous administration. 
 
 
Also in keeping with the first author’s training during his internship year, when he 
rotated on the Oncology service with Dr. Hankensen; is the principal that seriously ill 
patients do not spontaneously get better and timely responses to data is necessary to 
improve patient outcomes and reduce morbidity and mortality. For patients with 
cancer, who “spiked” a fever and demonstrated a bacterial infection, patients 
automatically underwent testing (applicable blood and other tests) to look for the 
source and agent of infection. Patients were simultaneously started in gram-positive 
and gram-negative coverage. If patients did not improve within 36-48 hours, a 
macrolide antibiotic was added. If no improvement was noted within 36-48 hours, an 
antifungal agent was initiated followed by antiviral therapy if no improvement was 
noted in the next 36-48 hours. Once the organism was identified, treatment was 
tailored back to the offending organism.  
 
 
CoVid-19 Pneumonia (CVP) and inflammation is no less serious and in many 
ways more so. Given the morbidity and mortality associated with CoVid-19, the 
treatment and diagnostic evaluation with FMTVDM, takes this same aggressive 
treatment approach.  

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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B. PROPOSED TREATMENT REGIMENS. [TREATMENT CONSISTS OF THREE COMPONENTS: (1) 
ONE OF THE 10 TREATMENTS LISTED BELOW, (2) THE IMMUNE SUPPORTIVE TREATMENT, 
AND (3) ATROVENT NEBULIZER TREATMENTS.] 
 
 
Since we do NOT YET know which medical regimen2 will be the most effective, 
it is our recommendation that each facility make a selection of treatments and 
randomly assigns patients to treatment groups. The following treatments are 
recommended based upon the information we currently have available.  
 
 
TREATMENT COMPONENT ONE3 4 
 
 
Treatment 1: Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of  
 
 
10-days, and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on 
 
 
 
days 2-5 (to prevent bacterial superinfection5). 
 
 
Treatment 2: Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of  
 
 
10-days, and Doxycycline 100mg IV q 12 hrs with each dose given over 1 
 
 
 
to 4-hours (to prevent bacterial superinfection6). 
 
 
Treatment 3: Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of  
 
 
10-days. Clindamycin7 150-450 mg po q6 hours x 10 days OR 4800 mg  
 
 
IV daily – beginning with 150 mg initial rapid infusion, followed by   
 
 
continuous infusion q 24-hours for 7-days. 
 
 
 
 
                                                
2 All routine blood testing and observations for potential treatment side effects must be observed. 
3 The dosages shown are for adult patients. Pediatric and adolescent dosage should be 
adjusted accordingly. 
4 FOR ANY PATIENT WITH QTc GREATER THAN 500 msec, or for 
which there is clinician concern for rhythm disturbance, ß1 blockers 
such as ATENOLOL OR ESMOLOL SHOULD BE USED TO 
REDUCE CONCERNS FOR PROLONGED QTc DYSRHYTHMIAS. 
5 And to inhibit ribosomal protein synthesis (translation) of CoVid-19. 
6 And to inhibit ribosomal protein synthesis (translation) of CoVid-19. 
7 Binding to 50S ribosomal subunit interfering with protein translation of virus. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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Treatment 48: Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of  
 
 
10-days. Primaquine9 200 mg po on day # 1. Clindamycin10 150-450 mg  
 
 
po q6 hours x 10 days OR 4800 mg IV daily – beginning with 150 mg  
 
 
initial rapid infusion, followed by continuous infusion q 24-hours for 7- 
 
 
days. 
 
 
 
 
 
Treatment 511: Hydroxychloroquine Day # 1: 800 mg po initially followed by 400  
 
 
mg 8 hours later.  Days 2 and 3: 400 mg po qD. Primaquine12 200 mg po 
 
 
on day # 1. Clindamycin13 150-450 mg po q6 hours x 10 days OR 4800  
 
 
mg IV daily – beginning with 150 mg initial rapid infusion, followed by  
 
 
continuous infusion q 24-hours for 7-days. 
 
 
 
 
 
Treatment 6: Remdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a  
 
 
total of 10-days. 
 
 
Treatment 7: Tocilizumab14 8mg/kg IV (not to exceed 800 mg) over 60-minutes.  
 
 
If clinical improvement is not noted, three additional doses may be  
 
 
administered at q 8-hour intervals from the initial infusion for a total of 4- 
 
 
doses maximum. ANY PATIENT DEMONSTRATING CYTOKINE RELEASE 
 
 
SYNDROME WILL HAVE THIS TREATMENT ARM AUTOMATICALLY  
 
 
ADDED. 
                                                
8 Treatments 4 and 5 are based upon malarial regimens previously used and shown to be 
effective in malarial eradication. 
9 Primaquine should not be given to G6PD deficiency patients.  
10 Binding to 50S ribosomal subunit interfering with protein translation of virus. 
11 Treatments 4 and 5 are based upon malarial regimens previously used and shown to be 
effective in malarial eradication. 
12 Primaquine should not be given to G6PD deficiency patients.  
13 Binding to 50S ribosomal subunit interfering with protein translation of virus. 
14 Monoclonal antibody inhibiting IL-6. Prescribed dosage regimen for Cytokine Release 
Syndrome (CRS) – aka Cytokine Storm. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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Treatment 8: Methylprednisolone 80 mg IV over 30-minutes, BID x 7-days. Then  
 
 
taper off. 
 
 
Treatment 9: Interferon alpha-2b 5 million units per nebulizer BID. 
 
 
Treatment 10: Losartan 25 mg po qD. 
 
 
Treatment 11: Plasma transfusions from CoVid-19 survivors. 
 
 
Treatment 12: Further treatments will be added or deleted based upon further  
 
 
Information, diagnostic outcomes or information we receive from you.      
  
 
 
Each patient should also have daily homocysteine (Hcy)15 levels checked. 
Elevations in Hcy are an indirect serum marker of a failed immune system as noted in 
the original “Inflammation and Heart Disease” Theory and measured treatment 
responses of bacterial infections aggravating CAD [3,7]. Electrocardiograms should 
also be obtained to monitor QTc intervals, as well as potassium and magnesium levels 
if QTc prolonged – for possible electrolyte replacement. 
 
 
Caution should be applied to the amount of blood taken from patients for 
diagnostic comparison testing – remembering and taking into account the minimum 
amount of blood needed from each patient for each test - and not simply filling 
vacutainer tubes of blood. 
 
TREATMENT COMPONENT TWO 
 
 
The following additional immune supportive treatment should be added to the 
above treatment regimens, focusing on immune function. 
 
 
Folate 3 mg qD, Magnesium 400 mg qD,  
 
Calcium Carbonate 400 mg qD, Vitamin B12 - 3 mg qD,  
 
Vitamin B6 - 30 mg qD, DHEA 50 mg BID,  
 
Vitamin C 2000 mg qD, Zinc 10 mg po or 4 mg IV16, and  
 
Vitamin D3 1500 IU qD. 
 
 
                                                
15 Patients should have daily labs including CBC with differential, CRP, LFT’s, renal function – 
a metabolic panel should include all renal, liver tests and electrolytes – and a serum ferritin for 
possible cytokine release syndrome. A daily nasal and/or oral PCR swab should be obtained to 
obtain comparison data of possible changes in this screening test and to compare with FMTVDM 
and clinical response. 
16 When possible Zinc should be given IV. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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TREATMENT COMPONENT THREE17 
 
 
To improve/enhance airway exchange of 02/CO2 and delivery of any nebulized 
Rx. 
 
 
 
Atrovent18 (ß2 bronchodilator) nebulizer treatments q 4-hours. 
 
VENTILATOR SETTINGS 
 
 
VENTILATOR SETTINGS19 FOR PATIENTS WITH ARDS SHOULD BE SET AT 5-
6 ML/KG BODY WT, WITH ADJUSTMENTS TO KEEP PEAK PLATEAU PRESSURE AT 
NO MORE THAN 30 CM H2). PRONE POSITIONING SHOULD BE CONSIDERED. 
 
 
By keeping track of the treatment response of patients using FMTVDM 
measurements, changes in medication regimens should focus on those showing 
the best FMTVDM treatment outcomes.  
 
 
Treatment recommendations from the 12 – targeted treatment options  
[additional targeted treatment options may be added] should be randomized so 
we can learn rapidly, what works and what doesn't, with changes in treatment 
based upon what is working in other patients and other hospitals. 
 
C. FMTVDM MEASUREMENT OF THE EXTENT OF DISEASE AND DETERMINATION OF 
TREATMENT RESPONSE. 
 
 
PLANAR BEDSIDE: Upon presentation a FMTVDM test will be conducted 
pursuant to FMTVDM patent including (a) quantitative calibration of the nuclear camera 
– preferably a portable planar20 camera to reduce transportation of patients (which 
would require additional personnel, problems with ventilatory assistance, etc), (b) 
enhancement to shift blood flow and isotope to areas with greater regional blood flow 
and metabolism followed by FMTVDM imaging and measurement21, (c) nuclear 
technologist drawn regions-of-interest (ROIs) for quantification as described above, (d) 
FMTVDM measurements, including entire right and left lung fields, thymus region and 
                                                
17 Improved exchange of O2/CO2 and ability to decrease tidal volumes – reducing further 
inflammatory changes within pulmonary tissue including ARDS. 
18 ß2 bronchodilator without cardiac effect enhancing airway function and O2/CO2 exchange. 
19 Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung 
injury and the acute respiratory distress syndrome. N Engl J Med 2000;342(18):1301-1308. 
20 LEHR collimator with initial setting of 128 x 128 matrix, with settings changed based 
upon Quantitative Calibration of camera as explained in Appendix A & B. It is not 
unexpected that following the initial calibration, that a change in matrix to 64 x 64 will be 
needed to address missed scintillated decay emissions. 
21 Lantheus isotopes and products are excluded from the study. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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all areas of visually apparent isolated isotope uptake. FMTVDM values will include 
maximum values +/- variance. 
 
 
NUCLEAR LABORATORY: For patients that are either not ventilated OR for 
those facilities which have established the protocol and dedicated nuclear camera for 
infectious patients – including CoVid-19 patients, imaging options include SPECT22, 
SPECT/CT, SPECT/MRI, PET, PET/CT or PET/MRI.  
 
 
The calibration and imaging sequence of the anatomic component (CT or MRI) 
of the RMTVDM study, should – at least for the present time – follow the currently used 
imaging standards established at each facility for each camera. 
 
 
The quantitative calibration of the PLANAR, SPECT and PET components of 
these cameras for FMTVDM imaging and quantification are detailed in Appendices A 
and B. 
 
 
  
D. SEQUENCE OF FMTVDM TESTING THROUGH COVID-19 DIAGNOSIS & TREATMENT. 
 
 
Patients will undergo treatment for 48-72 hours, based upon clinical status and 
staffing availability. The outcomes will be based upon measured changes in maximum 
+/- variance of FMTVDM values. [An increase in variance demonstrates changing 
pulmonary conditions while a smaller variance demonstrates consistency of tissue 
change. When coupled with the maximal FMTVDM measurements, variance provides 
information about the transitional changes occurring.] 
 
                                                
22 SPECT = single photon emission computed tomography; PET = positron emission 
tomography. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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FMTVDM MEASURED OUTCOMES OF TREATMENT 
 
SCENARIO 1: Patients demonstrate improvement after 48 to 72-hours of treatment.  
 
 
FMTVDM has been repeated and the quantified results of tissue change 
compared with the initial/prior study shows reductions in maximum FMTVDM numbers. 
If the results show improvement, then patients should remain on the regimen. 
FMTVDM should be repeated 3 to 7-days later to compare further tissue response to 
treatment and reassess further treatment. 
 
SCENARIO 2: Patients clinically deteriorates after 48 to 72-hours of treatment – or 
 
sooner if clinically indicated. 
 
 
FMTVDM numbers increase compared with the prior FMTVDM study. Treatment 
should be immediately changed – either randomly assigning another treatment from 
the above options OR selecting treatment which FMTVDM has shown to be beneficial 
in other patients - with another FMTVDM to be done 48 to 72-hours following this 
change in treatment to assess new treatment effect. 
 
SCENARIO 3: Patients demonstrate no change on FMTVDM compared with the prior 
 
study after 48 to 72-hours of treatment..  
 
 
Based upon these results, patient’s treatment will either (a) remain the same 
(based upon clinical signs), or (b) be modified (including additional drugs) - if the 
clinician believes there has been no improvement clinically or is concerned with clinical 
deterioration. Following this treatment decision, another FMTVDM should completed 
48 to 72-hours later to reassess treatment response. 
 
SUMMARY OF FMTVDM PATENT RIGHTS - #9566037 [1]. 
 
 
The publication of a proposed study is both an unusual practice for the authors 
and the journal - particularly when it includes the incorporation of intellectual property.  
 
 
As a routine, clinical research studies remain closely guarded secrets with 
information only released following completion of the study. However, these are not 
routine times. A pandemic has swept across the globe impacting almost every country 
in the world. The mortality rate associated with CoVid-19 is greater than anything seen 
in our lifetimes. It is overwhelming our medical systems, our economies and our 
peoples. 
 
 
Consequently, the primary author realizes that the dissemination of his 
intellectual property could be compromised by those choosing to take advantage of 
the information provided - but that is a concern, which must be addressed another 
day. Truly, the needs of the many, outweigh the needs of the few, or the one. In this 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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instance the first author is willing to take the chance that people will do the right thing 
as we share this information through the journal. 
 
 
Dr. Fleming will for the duration of this pandemic, following a signed NDA - 
either by the FDA to cover everyone, or from each institution - and explanation with 
each center further specific details on how FMTVDM is to be done, allow FMTVDM to 
be done on CoVid-19 patients waiving any licensing fees or royalties for this study and 
the treatment of these critically ill people. 
 
 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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SUMMARY OF THE TREATMENT PROTOCOLS FOR COVID-1923 
 
 
                                                
23 If the patient experiences Cytokine Release Syndrome (CRS) – Cytokine Storm – 
Tocilizumab is to be added immediately to the current treatment protocol OR IF 
THE FMTVDM RESULTS SHOW ACTIVATION OF THE THYMUS GLAND. 

COVID-19 FMTVDM PROTOCOL DATE: 8 APRIL 2020 
 
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FMTVDM MEASUREMENT REFERENCES 
 
1. The Fleming Method for Tissue and Vascular Differentiation and Metabolism 
(FMTVDM) using same state single or sequential quantification comparisons. 
Patent Number 9566037. Issued 02/14/2017.  
2. Fleming RM, Fleming MR, Dooley WC, Chaudhuri TK. Invited Editorial. The 
Importance of Differentiating Between Qualitative, Semi-Quantitative and 
Quantitative Imaging – Close Only Counts in Horseshoes. Eur J Nucl Med Mol 
Imaging. 2020;47(4):753-755. DOI:10.1007/s00259-019-04668-y. Published 
online 17 January 2020 https://link.springer.com/article/10.1007/s00259-019-
04668-y https://rdcu.be/b22Dd 
3. Fleming RM. Chapter 64. The Pathogenesis of Vascular Disease.  Textbook of 
Angiology.  John C. Chang Editor, Springer-Verlag New York, NY. 1999, pp. 
787-798. doi:10.1007/978-1-4612-1190-7_64. 
4. Fleming RM, Harrington GM, Baqir R. Heart Disease in Men. Chapter 3. Using 
Multiple Images Post-Stress to Enhance diagnostic Accuracy of Myocardial 
Perfusion Imaging: The Clinical Importance of Determining Washin and Washout 
Indicates a Parabolic Function between Coronary Perfusion (Blood Flow) and 
Cellular ("Uptake/Release") Function. Alice B. Todd and Margo H. Mosley 
Editors, 
Nova 
Publishers, 
2009, 
pp. 
75-100. 
(https://www.novapublishers.com/catalog/product_info.php?products _id=8409)  
5. Fleming RM, Harrington GM, Baqir R, Jay S, Challapalli S, Avery K, Green J. 
Renewed Application of an Old Method Improves Detection of Coronary 
Ischemia. A Higher Standard of Care. Federal Practitioner 2010;27:22-31.  
6. Fleming RM, Harrington GM. Chapter 13. Fleming Harrington Redistribution 
Wash-in Washout (FHRWW): The Platinum Standard for Nuclear Cardiology. 
Establishing Better Standards of Care in Doppler Echocardiography, Computed 
Tomography and Nuclear Cardiology. Richard M. Fleming, Editor, Intech 
Publishing July 2011. ISBN: 978-953-307-366-8. DOI:10.5772/22369.  
7. Fleming RM. The Fleming Unified Theory of Vascular Disease: A Link Between 
Atherosclerosis, Inflammation, and Bacterially Aggravated Atherosclerosis 
(BAA). Angiol 2000; 51: 87-89.  
 
 
TREATMENT REFERENCES 
 
 
1. Touret F, de Lamballerie X. Commentary Of Chloroquine and VOVID-19. Antiviral 
Research 2020;177:104762. doi:10.1016/j.antiviral.2020.104762. 
2. Colson P, Rolain J-M, Lagier J-C, Brouqui P, Raoult D. Chloroquine and 
hydroxychloroquine as available weapons to fight COVID-19. International 
Journal of Antimicrobial Agents (2020), doi: 
https://doi.org/10.1016/j.ijantimicag.2020.105932 

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3. Padberg S. Anti-infective Agents. 2015. Elsevier B.V. Drugs During Pregnancy 
and Lactation. http://dx.doi.org/10.1016/B978-0-12-408078-2.00007-X  
4. 8-Aminoquinoline – an overview. Science Direct Topics. 8-Aminoquinoline - an 
overview | Science Direct Topics.html  
5. Gautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a 
treatment of COVID-19: results of an open-label non-randomized clinical trial. 
medRxiv preprint doi: https://doi.org/10.1101/2020.03.16.20037135.  
6. Santarpia JL, Rivera DN, Herrera V, et al. Transmission Potential of SARS-CoV-2 
in Viral Shedding Observed at the University of Nebraska Medical Center. 
medRxiv preprint doi: https://doi.org/10.1101/2020.03.23.20039446.  
7. Cheng VCC, Lau SKP, Woo PCY, Wu R. Severe Acute Respiratory Syndrome 
Coronavirus as an Emerging and Reemerging Infection. Clinical Microbiology 
Reviews Oct. 2007:660-694. 
8. Wu Ruo, Lin S-y, Zhao H-m. Albuterol in the treatment of acute respiratory 
distress syndrome: A meta-analysis of randomized controlled trials. World J 
Emerg Med 2015;6(3):165-171. 
9. Arpaia N, Barton GM. Toll-like Receptors: Key Players in Antiviral Immunity. Curr 
Opin Virol 2011;1(6):447-454.  
10. Bhatraju PK, Ghassemieh BJ, Nichols M, et al. Covid-19 in Critically Ill Patients 
in the Seattle Region – Case Series. N Engl J Med 2020. DOI: 
10.1056/NEJMoa2004500. 
11. Med QLM, Guan X, Wu P, et al. Early Transmission Dynamics in Wuhan, China, 
of Novel Coronavirus – Infected Pneumonia. N Engl J Med 2020;382(13):1199-
1207. 
12. Haston JC, Hwang J, Tan KR. Guidance for Using Tafenoquine for Prevention 
and Antirelapse Therapy for Malaria – United States, 2019. MMWR 
2019;68(46):1062-1068. 
13. Shen C, Wang Z, Zhao F, et al. Treatment of 5 Critically Ill Patients With COVID-
19 With Convalescent Plasma JAMA 2020. Published online March 27, 2020. 
E1-E8. 
14. Gautret P, Lagier J-C, Parola P, et al. Clinical and microbiological effect of a 
combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients 
with at least a six-day follow up: an observational study. Prepublication galley. 
April 2020. 
15. Zheng F, Liao C, Fan Q-h, et al. Clinical Characteristics of Children with 
Coronavirus Disease 2019 in Hubei, China. Current Medical Science 
2020;40(2):1-6. 
16. Recht J, Ashley E, and White N. Safety of 8-Aminoguinoline Antimalarial 
Medicines. WHO 2014. ISBN 978 92 4 150697 7. 
17. Chen C, Gao G, Xu Y, et al. SARS-CoV-2-Positive Sputum and Feces After 
Conversion of Pharyngeal Samples in Patients With COVID-19. Annals of 
Internal Medicine. Published 30 March 2020:1-3. 
 
 
 

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TABLE 
 
Table 1. Characteristics distinguishing three approaches to diagnostic imaging [2].  
 
 
 
Table Legend: The use of anatomic tests like radiographs, computed tomography (CT), 
currently employed single photon emission computed tomography (SPECT), planar 
(stationary SPECT), positron emission tomography (PET) without standard uptake 
values (SUV), ultrasound, and tests providing anatomic data are qualitative. Tests such 
as coronary artery calcium (CAC) and PET with SUV’s are semi-quantitative using a 
series of assumptions. FMTVDM provides the only truly quantitative method for 
measuring tissue changes 
 

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Appendix E --- SCHEMATIC OF FINAL PROTOCOL SEQUENCE. 

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60 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX F--- FLEMING UNIFIED THEORY OF VASCULAR DISEASE (THE INFLAMMATION AND HEART 
 
DISEASE THEORY) EXPLAINS CRS & INCREASED BLOOD CLOTTING 
 
 
EXPLAINING WHY COVID-19 IS ASSOCIATED WITH INCREASED 
INFLAMMATORY DAMAGE AND THROMBOSIS. 
 
https://rmfmd71.wixsite.com/fhhi-omnific/cytokine-release-sydrome-crs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The human body is designed to protect people from damage caused by 
something entering and harming the body. Three relatively common examples 
include: 
 
1) The introduction or ingestion of something into the body, which harms the 
body. 
  
     Damage occurring within your body caused by poor diets (too much saturated 
fat and too many calories - producing heart disease, and disease in other blood 
vessels causing strokes, claudication, impotence, etc.), chemicals (carcinogens - 
substances that cause cancer), pollution (air, water, land - e.g. fertilizers), 
smoking (chemicals you voluntarily put into your body), et cetera. 
 
2) Cancer.  
  
     Changes occurring within your body, causing your cells to become abnormal 
and no longer function properly. These cells then threaten to take over the body. 
 
 
It is the ability to measure changes in tissue metabolism and regional blood 
flow, using FMTVDM that allows us to measure both the extent and severity of Wuhan 
CoVid-19 infections before and after treatment to determine if a treatment is working or 
needs to be changed. 
 
 

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3) Infection. 
 
     This includes, among other things, fungal, protozoan, sexually transmitted 
diseases, bacteria, and viruses, like CoVid-19. These infectious organisms then 
try to live off your body so they can thrive and reproduce themselves at your 
expense. 
 
     To protect you, your body has the ability to fight against this damage using 
your immune system. These special cells talk to each other using chemical 
messengers called interleukins (e.g. IL-6) or cytokines.  
 
     The “Inflammation and Heart Disease24” Theory first discussed in 1995,then 
later published in the Cardiology Textbook [reference #3 on page 13] in 1999, was 
briefly discussed during a 20/2025 segment in 2004, shows how the immune 
system is involved in this. 
 
     
 
                                                
24 Fleming-Harrington Redistribution Wash-in Washout (FHRWW) including stress-stress 
detection of inflammatory coronary artery disease. 1-655815511. Started 9-1-2011. Effective 9-
16-2011, #TX 7-446-683. 
25 https://www.youtube.com/watch?v=Hvb_Ced7KyA&t=22s 

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63 
     While there is a lot of information present in this one figure, if we look only at 
the right half of the figure (on the next page – p. 63) you can see how these 
infections, the chemical messengers used by your immune system and the 
compliment clotting cascade (chemicals in your body designed to recognize a 
problem and form blood clots), all work together to try to remove this harm and 
restore your body. 
 
     If the reaction to the damage - including that caused by the Wuhan CoVid-19 
Virus - is too little, the body cannot heal itself. If however, the reaction is too 
much (for a variety of reasons including the presentation of a virus which your 
body has never seen before), then the very process designed to protect the body 
can actually cause harm to the body.  
  
     Much like dropping a nuclear weapon on a city. It will wipe out the enemy, but 
there will be nothing left in its wake and you won't be able to send troops in 
because the area is toxic and will only harm your troops. 
  
 

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65 
     This excess is exactly what is talked about in the "Inflammation and Heart 
Disease" Theory and what accounts for the CoVid-19 problems (ARDS, strokes, 
blood clots, skin lesions, etc.) 
 
 
 
 
     Blindly treating CoVid-19 without measuring what is happening at the tissue 
level, is asking for trouble. Not addressing Cytokine Release Syndrome (CRS) or 
clotting26 problems (pulmonary emboli, deep venous thrombosis, etc.) is asking 
for problems. Not treating patients with Acute Respiratory Distress Syndrome 
(ARDS) accordingly, has arguably lead to many ventilator deaths. 
  
     That is why NCT04349410 not only includes a treatment arm to address CRS, 
but requires FMTVDM measurement of what the treatments are actually doing to 
the CoVid-19.  
 
 
As detailed in the “Inflammation and Heart Disease” Theory, viruses and 
the immunologic response to viruses, result in an inflammatory reaction that 
causes the release of cytokines and clotting. This reaction has both a local and 
systemic effect, which must be addressed to successfully treat the patient. There 
is the expectation that the presentation of a virus like CoVid-19, which has not 
previously been seen by the patient, may result in an intensified reaction as the 
immune system attempts to address the infecting organism.  
  
    Without FMTVDM measurement to objectively show clinicians what the 
treatment is doing to the virus, we are only guessing. 
                                                
26 All patients without contraindications should be placed on Heparin 5,000 units SQ BID if they 
are immobilized or confined to bed. Further treatment should be provided as clinically indicated. 

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APPENDIX G. FLEMING FMTVDM TREATMENT PROTOCOL EFFECTIVE 4 JULY 2020 
 

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