Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19

Summary

A preparation of CimertrA, comprising Artemisinin, Curcumin, and Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel coronavirus SARS-CoV-2. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed.

The severe acute respiratory syndrome-associated coronavirus disease 2019 (COVID-19) illness results from the immediate response to the viral infection as well as from a subsequent host inflammatory response. Systemic proinflammatory cytokines and biomarkers are elevated as the disease progresses towards its advanced stages, and correlate with worse chances of survival.

Serum cytokine levels that are elevated in patients with Covid-19-associated cytokine storm include interleukin-1β, interleukin-6, IP-10, TNF, interferon-γ, macrophage inflammatory protein (MIP) 1α and 1β, and VEGF. Higher interleukin-6 levels are strongly associated with shorter survival. The relative frequencies of circulating activated CD4+ and CD8+ T cells and plasmablasts are increased in Covid-19. In addition to the elevated systemic cytokine levels and activated immune cells, several clinical and laboratory abnormalities, such as elevated CRP and d-dimer levels, hypoalbuminemia, renal dysfunction, and effusions, are also observed in Covid-19. Laboratory test results reflecting hyper inflammation and tissue damage were found to predict worsening outcomes in Covid-19.

CimetrA, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, has been studied on patients with COVID-19 in a randomized double-blind control Phase II study (MGC-006 - under a previous product name - ArtemiC). The study product demonstrated excellent safety and efficacy profiles.

Experiments performed in vitro with CimetrA demonstrated the ability to reduce cytokine elevation in response to stimulation of human PBMC preparations.

The currently proposed Multi-center multinational-controlled study is designed to include 252 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments, and vital signs.

After the screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in addition to Standard of Care (Arm 1 (CimetrA-1) or Arm 2 (CimetrA-2)) or Placebo in addition to Standard of Care (Arm 3).

Conditions

• Corona Virus Infection
• Covid19
• SARS-CoV Infection

Interventions

DRUG

Placebo administration

patients will receive the placebo treatment in addition to Standard of Care

DIAGNOSTIC_TEST

Confirm SARS-CoV-2 infection

patients will be tested for SARS-CoV-2 on days 1, 14 and 28

PROCEDURE

Physical Examination

patients will undergo a physical examination on days 1-14 and day 28

PROCEDURE

Vital Signs

patient's vital signs will be measured on days 1-14 and day 28

DIAGNOSTIC_TEST

Hematology blood test

patients will provide a blood sample for a hematology blood test on days 1-14 and day 28

DIAGNOSTIC_TEST

Biochemistry blood test

patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28

OTHER

NEWS score

patient's NEWS score will be evaluated on days 1-14 and day 28

DIAGNOSTIC_TEST

PK test

PK test will be performed on day 1 only (only in Brazil sites)

DIAGNOSTIC_TEST

blood test for inflammatory markers

patients will provide a blood sample for an inflammatory markers blood test (IL-6, IL-1β, IL-12, TNF α, IFN-γ) on days 1-7, day 14, and day 28

DIAGNOSTIC_TEST

D-dimer test

patients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28

OTHER

VAS scale

patient's VAS scale will be evaluated on days 1-14, day 21, and day 28

DIAGNOSTIC_TEST

Urine pregnancy test for women of childbearing potential

patients will provide a urine sample for a urine pregnancy test on days 1, and day 28

PROCEDURE

ECG

patients will undergo an ECG examination on days 1, and day 28

OTHER

COVID-19-Impact on Quality of Life Questionnaire

patients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28

DRUG

CimetrA-1

patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care

DRUG

CimetrA-2

patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care

Sponsors & Collaborators

• MGC Pharmaceuticals d.o.o

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-11

Primary Completion

2023-02-28

Completion

2023-04-30

Countries

• Israel

Study Locations