Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
CimetrA
A Phase III, Double-blind , Controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
1 other identifier
interventional
252
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
June 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedAugust 24, 2022
August 1, 2022
1.6 years
March 10, 2021
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical improvement in treatment groups
Time to sustained clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of 2 Maintained for 24 Hours in comparison to routine treatment (measured on days 7, 14, 28)
up to 28 days
Secondary Outcomes (11)
oxygen dependency
up to 28 days
change in inflammatory marker levels
up to day 28
effective dose determination
up to 28 days
Pharmacokinetic profile
up to 28 days
Pharmacokinetic profile
up to 28 days
- +6 more secondary outcomes
Other Outcomes (3)
Duration of mechanical ventilation
up to day 28
Course of change in D Dimer levels compared to baseline
up to 28 days
Occurrence of secondary infections
up to 28 days
Study Arms (3)
Arm 1 - CimetrA-1
EXPERIMENTALa total dose containing a combination of Artemisinin 12 mg, Curcumin 40 mg, Boswellia 30 mg, and Vitamin C 120 mg in spray administration - divided into 4 separate doses given as an add on therapy, 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening).
Arm 2 - CimetrA-2
EXPERIMENTALa total dose containing a combination of Artemisinin 8.4 mg, Curcumin 28 mg, Boswellia 21 mg, and Vitamin C 84 mg in spray administration - divided into 4 separate doses given as an add on therapy, 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening).
Arm 3 - Placebo
PLACEBO COMPARATORcomposed of the same solvent but without active ingredients, given as an add on therapy in spray administration, 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening).
Interventions
patients will receive the placebo treatment in addition to Standard of Care
patients will be tested for SARS-CoV-2 on days 1, 14 and 28
patients will undergo a physical examination on days 1-14 and day 28
patient's vital signs will be measured on days 1-14 and day 28
patients will provide a blood sample for a hematology blood test on days 1-14 and day 28
patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28
patient's NEWS score will be evaluated on days 1-14 and day 28
PK test will be performed on day 1 only (only in Brazil sites)
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
patients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28
patient's VAS scale will be evaluated on days 1-14, day 21, and day 28
patients will provide a urine sample for a urine pregnancy test on days 1, and day 28
patients will undergo an ECG examination on days 1, and day 28
patients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28
patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care
patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care
Eligibility Criteria
You may qualify if:
- Confirmed SARS-CoV-2 infection (according to nationally authorized laboratory criteria)
- Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission.
- Age: 18 years old and above.
- Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
- Ability to receive treatment by spray into the oral cavity
You may not qualify if:
- Tube feeding or parenteral nutrition.
- Patients with scores 5 or above per the Ordinal Scale for Clinical Improvement published by the WHO. (i.e., who need oxygen supply beyond use of nozzles or simple mask)
- Need for admission to ICU during the present hospitalization at any time prior to completion of the recruitment to the study.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nazareth Hospital EMMS
Nazareth, North, Israel
Rambam Medical Center
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 17, 2021
Study Start
June 11, 2021
Primary Completion
February 1, 2023
Study Completion
April 1, 2023
Last Updated
August 24, 2022
Record last verified: 2022-08