The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

NCT04349410 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2020-11-12

No results posted yet for this study

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.

Conditions

  • CoVid 19 Positive

Interventions

DRUG

Hydroxychloroquine, Azithromycin

FMTVDM Planar, SPECT, PET

DRUG

Hydroxychloroquine, Doxycycline

FMTVDM Planar, SPECT, PET

DRUG

Hydroxychloroquine, Clindamycin

FMTVDM Planar, SPECT, PET

DRUG

Hydroxychloroquine, Clindamycin, Primaquine - low dose.

FMTVDM Planar, SPECT, PET

DRUG

Hydroxychloroquine, Clindamycin, Primaquine - high dose.

FMTVDM Planar, SPECT, PET

DRUG

Remdesivir

FMTVDM Planar, SPECT, PET

DRUG

Tocilizumab

FMTVDM Planar, SPECT, PET

DRUG

Methylprednisolone

FMTVDM Planar, SPECT, PET

DRUG

Interferon-Alpha2B

FMTVDM Planar, SPECT, PET

DRUG

Losartan

FMTVDM Planar, SPECT, PET

DRUG

Convalescent Serum

FMTVDM Planar, SPECT, PET

Sponsors & Collaborators

  • The Camelot Foundation

    lead OTHER

Principal Investigators

  • Richard M Fleming, PhD, MD, JD · FHHI-OI-Camelot;QME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-11
Primary Completion
2020-09-14
Completion
2020-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349410 on ClinicalTrials.gov