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The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol (FMTVDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349410
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
RM Fleming, MD, The Camelot Foundation

Brief 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.


Condition or disease Intervention/treatment Phase
CoVid 19 Positive Drug: Hydroxychloroquine, Azithromycin Drug: Hydroxychloroquine, Doxycycline Drug: Hydroxychloroquine, Clindamycin Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose. Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose. Drug: Remdesivir Drug: Tocilizumab Drug: Methylprednisolone Drug: Interferon-Alpha2B Drug: Losartan Drug: Convalescent Serum Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Measurement of CoVid-19 pneumonia (CVP) and inflammation will be made using a patented method (FMTVDM #9566037 and adjunct USPTO submissions deemed covered by USPTO under the original patent #9566037).

Following FMTVDM measurements, patients will be randomized into one of eleven treatment arms - others may be added as information becomes available. Forty-eight to 72-hours later - providing adequate time for treatment effect - FMTVDM will be repeated.

Patients with improvement in FMTVDM will be maintained on their original treatment. FMTVDM measured treatment failure will result in a change to another arm of treatment. FMTVDM measurement showing no change will be treated by adding an additional treatment arm to patient care. Sequential FMTVDM studies will be carried out.

Simultaneous Immune and ventilatory RX. Ventilatory support per ARDS protocol. Applicable blood tests and PCR will be included.

Masking: Single (Investigator)
Masking Description: As FMTVDM is an absolute quantification method, which cannot be influenced by human error or bias, the final determinant of success or failure of treatment cannot be influenced. However, given the pandemic, medical, nursing, technologist and other healthcare providers will NOT be blinded to data. The availability of the data will allow real time assessment and decision making by the clinicians involved in the care of the patient.
Primary Purpose: Treatment
Official Title: The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol
Actual Study Start Date : April 11, 2020
Estimated Primary Completion Date : October 11, 2020
Estimated Study Completion Date : November 11, 2020

Arm Intervention/treatment
Experimental: 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 superinfection ).
Drug: Hydroxychloroquine, Azithromycin
FMTVDM Planar, SPECT, PET

Experimental: 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 superinfection ).
Drug: Hydroxychloroquine, Doxycycline
FMTVDM Planar, SPECT, PET

Experimental: Treatment 3
Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days. Clindamycin 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.
Drug: Hydroxychloroquine, Clindamycin
FMTVDM Planar, SPECT, PET

Experimental: Treatment 4
Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days. Primaquine 200 mg po on day # 1. Clindamycin 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.
Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose.
FMTVDM Planar, SPECT, PET

Experimental: Treatment 5
Hydroxychloroquine Day # 1: 800 mg po initially followed by 400 mg 8 hours later. Days 2 and 3: 400 mg po qD. Primaquine 200 mg po on day # 1. Clindamycin 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.
Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose.
FMTVDM Planar, SPECT, PET

Experimental: Treatment 6
Remdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a total of 10-days.
Drug: Remdesivir
FMTVDM Planar, SPECT, PET

Experimental: Treatment 7

Tocilizumab 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.

Drug: Tocilizumab
FMTVDM Planar, SPECT, PET

Experimental: Treatment 8
Methylprednisolone 80 mg IV over 30-minutes, BID x 7-days. Then taper off.
Drug: Methylprednisolone
FMTVDM Planar, SPECT, PET

Experimental: Treatment 9
Interferon alpha-2b 5 million units per nebulizer BID.
Drug: Interferon-Alpha2B
FMTVDM Planar, SPECT, PET

Experimental: Treatment 10
Losartan 25 mg po qD.
Drug: Losartan
FMTVDM Planar, SPECT, PET

Experimental: Treatment 11
Plasma transfusions from CoVid-19 survivors.
Drug: Convalescent Serum
FMTVDM Planar, SPECT, PET




Primary Outcome Measures :
  1. Improvement in FMTVDM Measurement with nuclear imaging. [ Time Frame: 72 hours ]
    Measured improvement in tissue as measured using FMTVDM


Secondary Outcome Measures :
  1. Ventilator status [ Time Frame: 7 days ]
    Extubation

  2. Survival status [ Time Frame: 30 days ]
    Self explanatory



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: CoVid-19 -

Exclusion Criteria: Decision by patient to not participate.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349410


Locations
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United States, California
FHHI-OI-Camelot; QME
Los Angeles, California, United States, 90245
Sponsors and Collaborators
The Camelot Foundation
Investigators
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Study Chair: Richard M Fleming, PhD, MD, JD FHHI-OI-Camelot;QME
Additional Information:
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Responsible Party: RM Fleming, MD, Principle Investigator, The Camelot Foundation
ClinicalTrials.gov Identifier: NCT04349410    
Other Study ID Numbers: FMTVDM2020
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available through electronic request from approved individuals and institutions.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: This will depend upon the availability of staff given the multi-nation approach to this project.
Access Criteria: Expressed request through email as listed.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Interferons
Interferon-alpha
Interferon alpha-2
Azithromycin
Hydroxychloroquine
Doxycycline
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Primaquine
Methylprednisolone
Losartan
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Anti-Bacterial Agents
Anti-Arrhythmia Agents
Antihypertensive Agents