Covid19Phase 2CimetrANCT05037162
Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
A Phase 2 study testing Biochemistry blood test, Hematology blood test and D-Dimer test (coagulation) in people with Covid19 and Corona Virus Infection, run by MGC Pharmaceuticals d.o.o at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corona Virus Infection
- What is being tested?
- Biochemistry blood test, Hematology blood test and D-Dimer test (coagulation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Oct 2022to 1 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed by PCR test 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 (defined by NIH criteria - fever, cough, dyspnea, fast breathing, but no signs of severe pneumonia, including SpO2 ≥ 94% on room air).
- Age: 18 years old and above.
- Subjects must be hospitalized
- Ability to receive treatment by spray into the oral cavity
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIb, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
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.
Read the 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
- Being tested
- Biochemistry blood test, Hematology blood test, D-Dimer test (coagulation), Inflammatory markers, Vital signs
- Keywords
- Corona, covid19, COVID-19, coronavirus, corona virus infection, sars-cov-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemistry blood testDiagnostic 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,
Hematology blood testDiagnostic test
preformed on days 1-14 and day 28. complete CBC.
D-Dimer test (coagulation)Diagnostic test
performed on days 1,2,7,14 and 28.
Inflammatory markersDiagnostic test
performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ
Vital signsDiagnostic test
performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.
VAS scaleDiagnostic test
performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.
WHO Ordinal ScoreDiagnostic test
performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.
COVID-19-Related Symptoms assessmentDiagnostic test
performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.
COVID-19-Impact on Quality-of-Life QuestionnaireDiagnostic test
performed on days 1,7,14,21 and 28. score: 1-5 ; a higher score indicates a lower quality of life.
POST- COVID-19 Functional Status Scale:Diagnostic test
performed on day 28. score: 0-3 ; a higher score indicates better recovery.
Pregnancy testDiagnostic test
performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.
Physical examinationDiagnostic test
performed on days 1-14 and day 28. a full examination by a doctor.
PK parametersDiagnostic test
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)
SARS-CoV-2 test (PCR)Diagnostic test
performed on days 1,14 and 28.
ECGDiagnostic test
performed on days 1 and 28.
Treatment administration (twice a day)Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - CimetrA-1 | Experimental | CimetrA-1, with a total dose containing a combination of Curcumin 40 mg, Boswellia 30 mg and Vitamin C 120 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Receives: Diagnostic Test: Biochemistry blood test; Diagnostic Test: Hematology blood test; Diagnostic Test: D-Dimer test (coagulation); Diagnostic Test: Inflammatory markers; Diagnostic Test: Vital signs; Diagnostic Test: VAS scale; Diagnostic Test: WHO Ordinal Score; Diagnostic Test: COVID-19-Related Symptoms assessment; Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire; Diagnostic Test: POST- COVID-19 Functional Status Scale:; Diagnostic Test: Pregnancy test; Diagnostic Test: Physical examination; Diagnostic Test: PK parameters; Diagnostic Test: SARS-CoV-2 test (PCR); Diagnostic Test: ECG; Drug: Treatment administration (twice a day) |
| Arm 2 - CimetrA-2 | Experimental | CimetrA-2, with a total dose containing a combination of Curcumin 28 mg, Boswellia 21 mg and Vitamin C 84 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Receives: Diagnostic Test: Biochemistry blood test; Diagnostic Test: Hematology blood test; Diagnostic Test: D-Dimer test (coagulation); Diagnostic Test: Inflammatory markers; Diagnostic Test: Vital signs; Diagnostic Test: VAS scale; Diagnostic Test: WHO Ordinal Score; Diagnostic Test: COVID-19-Related Symptoms assessment; Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire; Diagnostic Test: POST- COVID-19 Functional Status Scale:; Diagnostic Test: Pregnancy test; Diagnostic Test: Physical examination; Diagnostic Test: PK parameters; Diagnostic Test: SARS-CoV-2 test (PCR); Diagnostic Test: ECG; Drug: Treatment administration (twice a day) |
| Arm 3 - Placebo | Placebo comparator | Placebo, composed of the same solvent but without active ingredients, given as an add on therapy in spray administration, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Receives: Diagnostic Test: Biochemistry blood test; Diagnostic Test: Hematology blood test; Diagnostic Test: D-Dimer test (coagulation); Diagnostic Test: Inflammatory markers; Diagnostic Test: Vital signs; Diagnostic Test: VAS scale; Diagnostic Test: WHO Ordinal Score; Diagnostic Test: COVID-19-Related Symptoms assessment; Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire; Diagnostic Test: POST- COVID-19 Functional Status Scale:; Diagnostic Test: Pregnancy test; Diagnostic Test: Physical examination; Diagnostic Test: PK parameters; Diagnostic Test: SARS-CoV-2 test (PCR); Diagnostic Test: ECG; Drug: Treatment administration (twice a day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WHO Ordinal Scale for clinical improvement
measured on days 1, 7, 14, 28 numerical value to assess the health status of the participant , scale is between 0-8 , The higher score means the worse outcome .
Measured: up to 28 days
Change in COVID-19-Related Symptoms score
measured on days 1,7, 14, 28 numerical value to assess the COVID-19-Related symptoms of participant scale is between 0-3, The higher score means the worse outcome .
score 0-3; higher score indicates worse outcome.
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of adverse events
Data management team will assess and review the AE's and SAE'S.
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood laboratory test.
Data management team will assess and review the lab test results (blood), assessment will be compared to the normal range. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of urine laboratory test.
Data management team will assess and review the lab test results (urine), assessment will be compared to the normal range. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood preasure
units: BPM (beats per minute) Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood satturation
units: %O2 Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Measured: up to 28 days
Safety endpoint: will be assessed through collection and analysis of body temperature
units: celsius degrees Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Measured: up to 28 days
Secondary outcomes (17)
Number of participants with depending on oxygen supplementation through day 28 since onset of symptoms
Measured: up to 28 days
Change in inflammatory marker levels - IL-6, IL-1β, IL-12, TNF α, IFN-γ, CRP, NLR (Neutrophil / Lymphocyte ratio) at days 1, 2, 4, 7, compared to baseline
Measured: up to 7 days
Pharmacokinetic profile of the study drug
Measurements :
CMAX elimination rate constant (denoted as K) half-life (t 1/2) apparent volume of distribution (V d) total clearance rate (CL). AUC
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - maximal concentartion
CMAX measurement (mg/ml)
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - elimination rate constant (denoted as K)
(mg/ml/min)
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - half-life
half-life t 1/2 (Min)
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - apparent volume of distribution
apparent volume of distribution V d (mL)
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - total clearance rate
total clearance rate CL (min/mg)
Measured: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - AUC
AUC (min)
Measured: on day 1 through 24 Hrs
duration of mechanical ventilation
in days
Measured: up to 28 days
Incidence of Intensive Care Unit (ICU) stay during COVID-19 complication
Measured: up to 28 days
Percentage of participants with definite or probable drug related adverse events
Measured: up to 28 days
Long term adverse events of COVID-19 on Day 28
The Outcome will Measure the number of patients who recovered from covid_19 , but still have adverse events.
Measured: up to 28 days
The Impact covid_19 on Quality of life of patients on Days 1, 14 and 28.
numerical value to assess the the impact of covid_19 on the quality life of the participant, scale is between 1-5, as expressed in the subject's subjective perception, The higher score is more important.
Measured: up to 28 days
Course of change in D Dimer levels compared to baseline
Measured: up to 28 days
Occurrence of secondary infections
Measured: up to 28 days
Incidence of mechanical ventilation
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start11 Oct 2022
- Primary completion21 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGC Pharmaceuticals d.o.o
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Nadaf, Study director, Galilee CBR - CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037162
- Sponsor's protocol ID
- MGC-009
- Acronym
- CimetrA
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT05037162
- Acronym / sponsor ID
- CimetrA / MGC-009
- Conditions
- Covid19, Corona Virus Infection
- Keywords
- Corona, covid19, COVID-19, coronavirus, corona virus infection, sars-cov-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- MGC Pharmaceuticals d.o.oIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - CimetrA-1 | Experimental | Diagnostic Test: Biochemistry blood test, Diagnostic Test: Hematology blood test, Diagnostic Test: D-Dimer test (coagulation), Diagnostic Test: Inflammatory markers, Diagnostic Test: Vital signs, Diagnostic Test: VAS scale, Diagnostic Test: WHO Ordinal Score, Diagnostic Test: COVID-19-Related Symptoms assessment, Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire, Diagnostic Test: POST- COVID-19 Functional Status Scale:, Diagnostic Test: Pregnancy test, Diagnostic Test: Physical examination, Diagnostic Test: PK parameters, Diagnostic Test: SARS-CoV-2 test (PCR), Diagnostic Test: ECG, Drug: Treatment administration (twice a day)CimetrA-1, with a total dose containing a combination of Curcumin 40 mg, Boswellia 30 mg and Vitamin C 120 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). |
| Arm 2 - CimetrA-2 | Experimental | Diagnostic Test: Biochemistry blood test, Diagnostic Test: Hematology blood test, Diagnostic Test: D-Dimer test (coagulation), Diagnostic Test: Inflammatory markers, Diagnostic Test: Vital signs, Diagnostic Test: VAS scale, Diagnostic Test: WHO Ordinal Score, Diagnostic Test: COVID-19-Related Symptoms assessment, Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire, Diagnostic Test: POST- COVID-19 Functional Status Scale:, Diagnostic Test: Pregnancy test, Diagnostic Test: Physical examination, Diagnostic Test: PK parameters, Diagnostic Test: SARS-CoV-2 test (PCR), Diagnostic Test: ECG, Drug: Treatment administration (twice a day)CimetrA-2, with a total dose containing a combination of Curcumin 28 mg, Boswellia 21 mg and Vitamin C 84 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). |
| Arm 3 - Placebo | Placebo comparator | Diagnostic Test: Biochemistry blood test, Diagnostic Test: Hematology blood test, Diagnostic Test: D-Dimer test (coagulation), Diagnostic Test: Inflammatory markers, Diagnostic Test: Vital signs, Diagnostic Test: VAS scale, Diagnostic Test: WHO Ordinal Score, Diagnostic Test: COVID-19-Related Symptoms assessment, Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire, Diagnostic Test: POST- COVID-19 Functional Status Scale:, Diagnostic Test: Pregnancy test, Diagnostic Test: Physical examination, Diagnostic Test: PK parameters, Diagnostic Test: SARS-CoV-2 test (PCR), Diagnostic Test: ECG, Drug: Treatment administration (twice a day)Placebo, composed of the same solvent but without active ingredients, given as an add on therapy in spray administration, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed by PCR test 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 (defined by NIH criteria - fever, cough, dyspnea, fast breathing, but no signs of severe pneumonia, including SpO2 ≥ 94% on room air).
- Age: 18 years old and above.
- Subjects must be hospitalized
- Ability to receive treatment by spray into the oral cavity
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemistry blood testpreformed 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 | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Hematology blood testpreformed on days 1-14 and day 28. complete CBC. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| D-Dimer test (coagulation)performed on days 1,2,7,14 and 28. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Inflammatory markersperformed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Vital signsperformed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| VAS scaleperformed on all study visits. score: 0-10 ; a higher score indicates a higher pain level. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| WHO Ordinal Scoreperformed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| COVID-19-Related Symptoms assessmentperformed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| COVID-19-Impact on Quality-of-Life Questionnaireperformed on days 1,7,14,21 and 28. score: 1-5 ; a higher score indicates a lower quality of life. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| POST- COVID-19 Functional Status Scale:performed on day 28. score: 0-3 ; a higher score indicates better recovery. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Pregnancy testperformed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Physical examinationperformed on days 1-14 and day 28. a full examination by a doctor. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| PK parametersperformed 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 | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| SARS-CoV-2 test (PCR)performed on days 1,14 and 28. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| ECGperformed on days 1 and 28. | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| 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) | Drug | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
Primary outcome
Change in WHO Ordinal Scale for clinical improvement
Time frame: up to 28 days
measured on days 1, 7, 14, 28 numerical value to assess the health status of the participant , scale is between 0-8 , The higher score means the worse outcome .
Change in COVID-19-Related Symptoms score
Time frame: up to 28 days
measured on days 1,7, 14, 28 numerical value to assess the COVID-19-Related symptoms of participant scale is between 0-3, The higher score means the worse outcome . score 0-3; higher score indicates worse outcome.
Safety endpoint: will be assessed through collection and analysis of adverse events
Time frame: up to 28 days
Data management team will assess and review the AE's and SAE'S.
Safety endpoint: will be assessed through collection and analysis of blood laboratory test.
Time frame: up to 28 days
Data management team will assess and review the lab test results (blood), assessment will be compared to the normal range. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Safety endpoint: will be assessed through collection and analysis of urine laboratory test.
Time frame: up to 28 days
Data management team will assess and review the lab test results (urine), assessment will be compared to the normal range. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Safety endpoint: will be assessed through collection and analysis of blood preasure
Time frame: up to 28 days
units: BPM (beats per minute) Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Safety endpoint: will be assessed through collection and analysis of blood satturation
Time frame: up to 28 days
units: %O2 Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Safety endpoint: will be assessed through collection and analysis of body temperature
Time frame: up to 28 days
units: celsius degrees Data management team will assess and review the vital signs : blood pressure [mm Hg], saturation [%], body temperature [C] , Each category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
17 secondary outcomes
Number of participants with depending on oxygen supplementation through day 28 since onset of symptoms
Time frame: up to 28 days
Change in inflammatory marker levels - IL-6, IL-1β, IL-12, TNF α, IFN-γ, CRP, NLR (Neutrophil / Lymphocyte ratio) at days 1, 2, 4, 7, compared to baseline
Time frame: up to 7 days
Pharmacokinetic profile of the study drug
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - maximal concentartion
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - elimination rate constant (denoted as K)
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - half-life
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - apparent volume of distribution
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - total clearance rate
Time frame: on day 1 through 24 Hrs
Pharmacokinetic profile of the study drug - AUC
Time frame: on day 1 through 24 Hrs
duration of mechanical ventilation
Time frame: up to 28 days
Incidence of Intensive Care Unit (ICU) stay during COVID-19 complication
Time frame: up to 28 days
Percentage of participants with definite or probable drug related adverse events
Time frame: up to 28 days
Long term adverse events of COVID-19 on Day 28
Time frame: up to 28 days
The Impact covid_19 on Quality of life of patients on Days 1, 14 and 28.
Time frame: up to 28 days
Course of change in D Dimer levels compared to baseline
Time frame: up to 28 days
Occurrence of secondary infections
Time frame: up to 28 days
Incidence of mechanical ventilation
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Nadaf study director
Galilee CBR - CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biochemistry blood test, Hematology blood test and D-Dimer test (coagulation) in people with Covid19 and Corona Virus Infection, run by MGC Pharmaceuticals d.o.o at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WHO Ordinal Scale for clinical improvement (time frame: up to 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.