The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

NCT04349410 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: FMTVDM2020
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

CoVid 19 Positive

Outcome Measures

Primary Outcomes (1)

• Improvement in FMTVDM Measurement with nuclear imaging.

  Measured improvement in tissue as measured using FMTVDM

  72 hours

Secondary Outcomes (2)

• Ventilator status

  7 days

• Survival status

  30 days

Study Arms (11)

Treatment 1

EXPERIMENTAL

Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on days 2-5 (to prevent bacterial superinfection ).

Drug: Hydroxychloroquine, Azithromycin

Treatment 2

EXPERIMENTAL

Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Doxycycline 100mg IV q 12 hrs with each dose given over 1 to 4-hours (to prevent bacterial superinfection ).

Drug: Hydroxychloroquine, Doxycycline

Treatment 3

EXPERIMENTAL

Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated 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

Treatment 4

EXPERIMENTAL

Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated 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.

Treatment 5

EXPERIMENTAL

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. This treatment arm is not available for intubated patients due to the absence of an IV form of Primaquine.

Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose.

Treatment 6

EXPERIMENTAL

Remdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a total of 10-days.

Drug: Remdesivir

Treatment 7

EXPERIMENTAL

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

Treatment 8

EXPERIMENTAL

Methylprednisolone 125 mg IV every 6-hours for 3 days; then 125 mg IV every 12-hours for 2 days; then 125 mg IV daily for 2 days; then 60 mg IV daily for 2 days \[with each infusion given over 30-minutes\]; then Solumedrol dose pack to taper off steroids.

Drug: Methylprednisolone

Treatment 9

EXPERIMENTAL

Interferon alpha-2b 5 million units per nebulizer BID.

Drug: Interferon-Alpha2B

Treatment 10

EXPERIMENTAL

Losartan 25 mg po qD. IRB held due to questions about benefit.

Drug: Losartan

Treatment 11

EXPERIMENTAL

Convalescent Plasma 2-units ABO-compatible with antibody titer of 1:320 dilution. Each unit intravenously infused over 4-hours.

Drug: Convalescent Serum

Interventions

Hydroxychloroquine, Azithromycin DRUG

FMTVDM Planar, SPECT, PET

Treatment 1

Hydroxychloroquine, Doxycycline DRUG

FMTVDM Planar, SPECT, PET

Treatment 2

Hydroxychloroquine, Clindamycin DRUG

FMTVDM Planar, SPECT, PET

Treatment 3

Hydroxychloroquine, Clindamycin, Primaquine - low dose. DRUG

FMTVDM Planar, SPECT, PET

Treatment 4

Hydroxychloroquine, Clindamycin, Primaquine - high dose. DRUG

FMTVDM Planar, SPECT, PET

Treatment 5

Remdesivir DRUG

FMTVDM Planar, SPECT, PET

Treatment 6

Tocilizumab DRUG

FMTVDM Planar, SPECT, PET

Treatment 7

Methylprednisolone DRUG

FMTVDM Planar, SPECT, PET

Treatment 8

Interferon-Alpha2B DRUG

FMTVDM Planar, SPECT, PET

Treatment 9

Losartan DRUG

FMTVDM Planar, SPECT, PET

Treatment 10

Convalescent Serum DRUG

FMTVDM Planar, SPECT, PET

Treatment 11

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Camelot Foundation: lead

Study Sites (1)

FHHI-OI-Camelot; QME

Los Angeles, California, 90245, United States

Location

Related Links

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

MeSH Terms

Interventions

Hydroxychloroquine; Azithromycin; Doxycycline; Clindamycin; Primaquine; remdesivir; tocilizumab; Methylprednisolone; Interferon-alpha2b; Losartan; COVID-19 Serotherapy

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Biphenyl Compounds; Benzene Derivatives; Imidazoles; Azoles; Tetrazoles; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Richard M Fleming, PhD, MD, JD

  FHHI-OI-Camelot;QME

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 16, 2020
• Study Start: April 11, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)