NCT05037162

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

A Phase IIb, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: MGC Pharmaceuticals d.o.o · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center multinational-controlled study in Israel, Brazil, Spain, and South-Africa. 240 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 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 two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo) in addition to Standard of Care- Arm 3.

Detailed description

A preparation of CimertA (Botanical Drug), comprising Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus 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 breakout of a lethal pneumonia in the city of Wuhan, China, towards the end of 2019, has led to the characterization of the new coronavirus related disease COVID-19. Its prominent features include a high rate of person-to-person transmission, a substantial risk of developing a lethal respiratory syndrome and potential failure of additional organs. Risk factors for a life-threatening clinical course have been identified, including advanced age and assorted comorbidities, such as cardiovascular disease, diabetes mellitus, hypertension, cancer. However, individuals devoid of any of the recognized risk factors are not immune to the severe manifestation of the disease and once infected carry a certain risk of mortality which has been calculated in Italy at circa 2%. CoV is an enveloped, positive-sense single-stranded RNA (ss-RNA) virus belonging to the Coronaviridae family. The severe acute respiratory syndrome associated coronavirus disease 2019 (COVID-19) illness is a syndrome of viral replication in concert with a host inflammatory response. The cytokine storm and viral evasion of cellular immune responses may play an equally important role in the pathogenesis, clinical manifestation, and outcomes of COVID-19. Systemic proinflammatory cytokines and biomarkers are elevated as the disease progresses towards its advanced stages, and correlate with worse chances of survival. SARS-CoV-2 activates the innate immune system and results in a release of a large number of cytokines, including IL-6, which can increase vascular permeability and cause a migration of fluid and blood cells into the alveoli as well as the consequent symptoms such as dyspnea and respiratory failure. The higher mortality is being linked to the result of ARDS (acute respiratory distress syndrome) aggravation and the tissue damage that can result in organ-failure and/or death. 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 plasma blasts 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, as they are in cytokine storm disorders. Laboratory test results reflecting hyperinflammation and tissue damage were found to predict worsening outcomes in Covid-19. CimetrA, comprising Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, was studied on patients with the novel corona virus SARS-CoV-2 in randomized double blind control Phase II study (MGC-006 - under a previous product name - ArtemiC). The study product demonstrated excellent safety and efficacy profiles. In the in vitro clinical trial CimetrA demonstrated the ability to reduce cytokines elevation in PBMC induced cell tissue.

Conditions

• Covid19
• Corona Virus Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biochemistry blood test	preformed on days 1-14 and day 28. Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL,
DIAGNOSTIC_TEST	Hematology blood test	preformed on days 1-14 and day 28. complete CBC.
DIAGNOSTIC_TEST	D-Dimer test (coagulation)	performed on days 1,2,7,14 and 28.
DIAGNOSTIC_TEST	Inflammatory markers	performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ
DIAGNOSTIC_TEST	Vital signs	performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.
DIAGNOSTIC_TEST	VAS scale	performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.
DIAGNOSTIC_TEST	WHO Ordinal Score	performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.
DIAGNOSTIC_TEST	COVID-19-Related Symptoms assessment	performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.
DIAGNOSTIC_TEST	COVID-19-Impact on Quality-of-Life Questionnaire	performed on days 1,7,14,21 and 28. score: 1-5 ; a higher score indicates a lower quality of life.
DIAGNOSTIC_TEST	POST- COVID-19 Functional Status Scale:	performed on day 28. score: 0-3 ; a higher score indicates better recovery.
DIAGNOSTIC_TEST	Pregnancy test	performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.
DIAGNOSTIC_TEST	Physical examination	performed on days 1-14 and day 28. a full examination by a doctor.
DIAGNOSTIC_TEST	PK parameters	performed on day 1. will be performed only on 14 patients that will agree to participate in the PK analysis (only for Brazil,Spain). The PK will be performed only for the first dose of drug, after patient received the first dose (5 puffs) the study staff need to follow the table below. For each test, approximately 5 ml of blood will be drawn (equivalent to one teaspoon)
DIAGNOSTIC_TEST	SARS-CoV-2 test (PCR)	performed on days 1,14 and 28.
DIAGNOSTIC_TEST	ECG	performed on days 1 and 28.
DRUG	Treatment administration (twice a day)	performed on days 1 and 2. twice a day, morning, and evening 1:1:1 ratio to study drug (CimetrA-1) (Arm 1) or study drug (CimetrA-2) or to Placebo (Arm 3)

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-01-21
• Completion: 2023-03-01
• First posted: 2021-09-08
• Last updated: 2023-03-15

Locations

1 site across 1 country: Israel