NCT04349410: FMTVDM

The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Completed Phase 2, PHASE3 Last updated 12 November 2020

What this trial tests

Phase 2, PHASE3 trial testing Hydroxychloroquine, Azithromycin in CoVid 19 Positive in 1,800 participants. Completed in 14 September 2020.

Timeline

11 April 2020

Primary endpoint
14 September 2020

14 September 2020

Quick facts

Lead sponsor	The Camelot Foundation
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	1,800
Start date	11 April 2020
Primary completion	14 September 2020
Estimated completion	14 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Hydroxychloroquine, Azithromycin
• Hydroxychloroquine, Doxycycline
• Hydroxychloroquine, Clindamycin
• Hydroxychloroquine, Clindamycin, Primaquine - low dose.
• Hydroxychloroquine, Clindamycin, Primaquine - high dose.
• Remdesivir
• Tocilizumab (tocilizumab) — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →
• Interferon-Alpha2B
• Losartan (losartan) — full drug profile →
• Convalescent Serum

Conditions studied

• CoVid 19 Positive — all drugs for CoVid 19 Positive →

Sponsor

The Camelot Foundation

Who can join

Eligibility, any sex, with CoVid 19 Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug repurposing approach to fight COVID-19.
   Singh TU, Parida S, Lingaraju MC, Kesavan M, et al · · 2020 · cited 299× · PMID 32889701 · DOI 10.1007/s43440-020-00155-6
2. Remdesivir against COVID-19 and Other Viral Diseases.
   Malin JJ, Suárez I, Priesner V, Fätkenheuer G, et al · · 2020 · cited 202× · PMID 33055231 · DOI 10.1128/cmr.00162-20
3. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
4. The emergence of COVID-19 as a global pandemic: Understanding the epidemiology, immune response and potential therapeutic targets of SARS-CoV-2.
   Muralidar S, Ambi SV, Sekaran S, Krishnan UM. · · 2020 · cited 184× · PMID 32971147 · DOI 10.1016/j.biochi.2020.09.018
5. Platelet and Endothelial Activation as Potential Mechanisms Behind the Thrombotic Complications of COVID-19 Patients.
   Canzano P, Brambilla M, Porro B, Cosentino N, et al · · 2021 · cited 170× · PMID 33649738 · DOI 10.1016/j.jacbts.2020.12.009
6. Remdesivir and its antiviral activity against COVID-19: A systematic review.
   Frediansyah A, Nainu F, Dhama K, Mudatsir M, et al · · 2021 · cited 133× · PMID 32838064 · DOI 10.1016/j.cegh.2020.07.011
7. ACE2 imbalance as a key player for the poor outcomes in COVID-19 patients with age-related comorbidities - Role of gut microbiota dysbiosis.
   Viana SD, Nunes S, Reis F. · · 2020 · cited 122× · PMID 32683039 · DOI 10.1016/j.arr.2020.101123
8. Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
   Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608