The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

CoVid 19 Positive Clinical Trial

— FMTVDM  

Official title:

The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349410
• Other study ID #: FMTVDM2020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 11, 2020
• Est. completion date: September 14, 2020

Study information

• Verified date: October 2020
• Source: The Camelot Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

FMTVDM - 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.

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 approved - 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.

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 tissue transitioning process the patient is. The measurements also provide information about how rapidly the tissue is changing. 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: CoVid-19 -

Exclusion Criteria: Decision by patient to not participate.

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Related Conditions & MeSH terms

• CoVid 19 Positive

Intervention

Drug:
• Hydroxychloroquine, Azithromycin
FMTVDM Planar, SPECT, PET
• Hydroxychloroquine, Doxycycline
FMTVDM Planar, SPECT, PET
• Hydroxychloroquine, Clindamycin
FMTVDM Planar, SPECT, PET
• Hydroxychloroquine, Clindamycin, Primaquine - low dose.
FMTVDM Planar, SPECT, PET
• Hydroxychloroquine, Clindamycin, Primaquine - high dose.
FMTVDM Planar, SPECT, PET
• Remdesivir
FMTVDM Planar, SPECT, PET
• Tocilizumab
FMTVDM Planar, SPECT, PET
• Methylprednisolone
FMTVDM Planar, SPECT, PET
• Interferon-Alpha2B
FMTVDM Planar, SPECT, PET
• Losartan
FMTVDM Planar, SPECT, PET
• Convalescent Serum
FMTVDM Planar, SPECT, PET

Locations

Country	Name	City	State
United States	FHHI-OI-Camelot; QME	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
The Camelot Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in FMTVDM Measurement with nuclear imaging.	Measured improvement in tissue as measured using FMTVDM	72 hours
Secondary	Ventilator status	Extubation	7 days
Secondary	Survival status	Self explanatory	30 days

External Links

•   FMTVDM Patent # 9566037
•   FMTVDM quantification.
•   Infection and Inflammation reversal by treatment of pathogens with associated reductions in IL-6.
•   The Critical Importance of Quantifying Tissue Change instead of using qualitative or semi-quanitified results.