The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Conditions

• CoVid 19 Positive

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 11, 2020

Status verified

Oct 2020

Primary completion

Sep 14, 2020

Completion

Sep 14, 2020

Study Design

Enrollment

1,800 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment 1
  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 ).
• Experimental: Treatment 2
  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 ).
• Experimental: Treatment 3
  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.
• Experimental: Treatment 4
  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.
• Experimental: Treatment 5
  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.
• Experimental: Treatment 6
  Remdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a total of 10-days.
• 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.
• Experimental: Treatment 8
  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.
• Experimental: Treatment 9
  Interferon alpha-2b 5 million units per nebulizer BID.
• Experimental: Treatment 10
  Losartan 25 mg po qD. IRB held due to questions about benefit.
• Experimental: Treatment 11
  Convalescent Plasma 2-units ABO-compatible with antibody titer of 1:320 dilution. Each unit intravenously infused over 4-hours.

Primary Outcome Measure

Improvement in FMTVDM Measurement with nuclear imaging. [ Time Frame: 72 hours ]

Locations (1)

Find similar trials in Los Angeles, CA