Corona Virus InfectionPhase 3CimetrANCT04802382
Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
A Phase 3 study testing Confirm SARS-CoV-2 infection, Physical Examination and Vital Signs in people with Corona Virus Infection and Covid19, run by MGC Pharmaceuticals d.o.o at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Covid19, SARS-CoV Infection
- What is being tested?
- Confirm SARS-CoV-2 infection, Physical Examination and Vital Signs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 2 sitesIsrael
- Study dates
- 11 Jun 2021to Apr 2023
- Phase
- Phase 3
- 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 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
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
2 sites in 1 country.
Israel2 sites
Rambam Medical Center
Haifa
Nazareth Hospital EMMS
Nazareth, North
About this study
Official title: A Phase III, Double-blind , Controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
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.
Read more
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).
Read the detailed description
The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule.
252 adult patients who suffer from COVID-19 infection and do not participate in any other clinical trial. The patient must not agree to participate in any new clinical study during the study duration. The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule.
Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a signed declination), and review and sign an ICF. Following procedures will be performed during the visit -
- Inclusion/Exclusion criteria evaluation
- Informed Consent
- Medical History
- Concomitant Medications
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- NEWS score
- PK test (brazil only, central)*
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Urine pregnancy test for women of childbearing potential
- ECG
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
- Randomization 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)
- Treatment administration (twice a day, morning and evening)
- Test for detection COVID-19 (within 5 days from admission to hospital)
Day 2
- Concomitant Medications
- AE Assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- NEWS score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Treatment administration (twice a day, morning and evening)
Days 3-6
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test **
- Biochemistry blood test **
- News score **
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- VAS scale
Day 7
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Days 8-13
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test **
- Biochemistry blood test **
- News score **
- VAS scale
Day 14
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Test for detection COVID-19
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Day 21 (phone visit)
- Concomitant Medications
- AE assessment
- VAS scale
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Day 28 - Follow Up (clinic visit)
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Test for detection COVID-19
- Urine pregnancy test for women of childbearing potential
- ECG
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
- Conditions
- Corona Virus Infection, Covid19, SARS-CoV Infection
- Being tested
- Placebo administration, Confirm SARS-CoV-2 infection, Physical Examination, Vital Signs, Hematology blood test
- Keywords
- corona, covid19, covid, coronavirus, corona virus infection, sars-cov-2
- Medical subject headings
- Coronavirus Infections, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo administrationDrug
patients will receive the placebo treatment in addition to Standard of Care
Confirm SARS-CoV-2 infectionDiagnostic test
Also called Covid-19 test
patients will be tested for SARS-CoV-2 on days 1, 14 and 28
Physical ExaminationProcedure or surgery
patients will undergo a physical examination on days 1-14 and day 28
Vital SignsProcedure or surgery
patient's vital signs will be measured on days 1-14 and day 28
Hematology blood testDiagnostic test
Also called blood tests
patients will provide a blood sample for a hematology blood test on days 1-14 and day 28
Biochemistry blood testDiagnostic test
Also called blood tests
patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28
NEWS scoreOther
Also called scoring
patient's NEWS score will be evaluated on days 1-14 and day 28
PK testDiagnostic test
Also called pharmacokinetics
PK test will be performed on day 1 only (only in Brazil sites)
blood test for inflammatory markersDiagnostic test
Also called blood tests
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
D-dimer testDiagnostic test
Also called blood tests
patients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28
VAS scaleOther
Also called scoring
patient's VAS scale will be evaluated on days 1-14, day 21, and day 28
Urine pregnancy test for women of childbearing potentialDiagnostic test
Also called pregnancy test
patients will provide a urine sample for a urine pregnancy test on days 1, and day 28
ECGProcedure or surgery
patients will undergo an ECG examination on days 1, and day 28
COVID-19-Impact on Quality of Life QuestionnaireOther
patients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28
CimetrA-1Drug
Also called CimetrA-1 drug administration
patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care
CimetrA-2Drug
Also called CimetrA- 2 drug administration
patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - CimetrA-1 | Experimental | a 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). Receives: Diagnostic Test: Confirm SARS-CoV-2 infection; Procedure: Physical Examination; Procedure: Vital Signs; Diagnostic Test: Hematology blood test; Diagnostic Test: Biochemistry blood test; Other: NEWS score; Diagnostic Test: PK test; Diagnostic Test: blood test for inflammatory markers; Diagnostic Test: D-dimer test; Other: VAS scale; Diagnostic Test: Urine pregnancy test for women of childbearing potential; Procedure: ECG; Other: COVID-19-Impact on Quality of Life Questionnaire; Drug: CimetrA-1 |
| Arm 2 - CimetrA-2 | Experimental | a 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). Receives: Diagnostic Test: Confirm SARS-CoV-2 infection; Procedure: Physical Examination; Procedure: Vital Signs; Diagnostic Test: Hematology blood test; Diagnostic Test: Biochemistry blood test; Other: NEWS score; Diagnostic Test: PK test; Diagnostic Test: blood test for inflammatory markers; Diagnostic Test: D-dimer test; Other: VAS scale; Diagnostic Test: Urine pregnancy test for women of childbearing potential; Procedure: ECG; Other: COVID-19-Impact on Quality of Life Questionnaire; Drug: CimetrA-2 |
| Arm 3 - Placebo | Placebo comparator | composed 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). Receives: Drug: Placebo administration; Diagnostic Test: Confirm SARS-CoV-2 infection; Procedure: Physical Examination; Procedure: Vital Signs; Diagnostic Test: Hematology blood test; Diagnostic Test: Biochemistry blood test; Other: NEWS score; Diagnostic Test: PK test; Diagnostic Test: blood test for inflammatory markers; Diagnostic Test: D-dimer test; Other: VAS scale; Diagnostic Test: Urine pregnancy test for women of childbearing potential; Procedure: ECG; Other: COVID-19-Impact on Quality of Life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 28 days
Secondary outcomes (11)
oxygen dependency
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
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, 14, 28
Measured: up to day 28
effective dose determination
Definition of the active dose of CimetrA
Measured: up to 28 days
Pharmacokinetic profile
Pharmacokinetic profile of the study drug-AUC(mmol/L·h)
Measured: up to 28 days
Pharmacokinetic profile
Pharmacokinetic profile of the study drug-Tmax (Hour)
Measured: up to 28 days
Pharmacokinetic profile
Pharmacokinetic profile of the study drug-Cmax (mmol/L)
Measured: up to 28 days
Incidence of mechanical ventilation
Incidence of mechanical ventilation
Measured: up to 28 days
Incidence of Intensive Care Unit (ICU) stay during COVID-19 complication
Incidence of Intensive Care Unit (ICU) stay during COVID-19 complication
Measured: up to 28 days
evaluation of drug related adverse events
Percentage of participants with definite or probable drug related adverse events
Measured: up to 28 days
Long term adverse events of COVID-19
Long term adverse events of COVID-19 on Day 28
Measured: up to 28 days
Quality of life of patients
Quality of life of patients on Days 0, 14 and 28. COVID-19 - Impact on Quality of Life (COV19-QoL) scale questionnaire. The scale was made in order to serve as a tool for controlling the impact of the situation with the COVID19 pandemic in general on findings of various research on mental health.The higher score, the greater impact on quality of life and related domains subjectively perceived by the participants.
Scores could be displayed and analyzed for each item separately. recommend the following way of calculating the total score for each participant: summing the scores on all of the items and dividing that result by the number of items (i.e. 6). Hence, the total score will be the average of all the items. The average score is measured between 1-5 scale.
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 posted17 Mar 2021
- Study start11 Jun 2021
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in 1:1:1 ratio to one of the three arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGC Pharmaceuticals d.o.o
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802382
- Sponsor's protocol ID
- MGC-008
- Acronym
- CimetrA
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind , Controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04802382
- Acronym / sponsor ID
- CimetrA / MGC-008
- Conditions
- Corona Virus Infection, Covid19, SARS-CoV Infection
- Keywords
- corona, covid19, covid, coronavirus, corona virus infection, sars-cov-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- MGC Pharmaceuticals d.o.oIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 17 Mar 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.
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).
Detailed description
The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule.
252 adult patients who suffer from COVID-19 infection and do not participate in any other clinical trial. The patient must not agree to participate in any new clinical study during the study duration. The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule.
Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a signed declination), and review and sign an ICF. Following procedures will be performed during the visit -
- Inclusion/Exclusion criteria evaluation
- Informed Consent
- Medical History
- Concomitant Medications
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- NEWS score
- PK test (brazil only, central)*
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Urine pregnancy test for women of childbearing potential
- ECG
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
- Randomization 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)
- Treatment administration (twice a day, morning and evening)
- Test for detection COVID-19 (within 5 days from admission to hospital)
Day 2
- Concomitant Medications
- AE Assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- NEWS score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Treatment administration (twice a day, morning and evening)
Days 3-6
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test **
- Biochemistry blood test **
- News score **
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- VAS scale
Day 7
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Days 8-13
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test **
- Biochemistry blood test **
- News score **
- VAS scale
Day 14
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Test for detection COVID-19
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Day 21 (phone visit)
- Concomitant Medications
- AE assessment
- VAS scale
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Day 28 - Follow Up (clinic visit)
- Concomitant Medications
- AE assessment
- Physical Examination
- Vital Signs
- Hematology blood test (local, mandatory even if there are available results from the day before)
- Biochemistry blood test (local, mandatory even if there are available results from the day before)
- News score
- Blood test for inflammatory markers (IL-6, IL-1β, IL-12, TNF α, IFN-γ) (local)
- D-Dimer test (local)
- VAS scale
- Test for detection COVID-19
- Urine pregnancy test for women of childbearing potential
- ECG
- COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized in 1:1:1 ratio to one of the three arms.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - CimetrA-1 | Experimental | Diagnostic Test: Confirm SARS-CoV-2 infection, Procedure: Physical Examination, Procedure: Vital Signs, Diagnostic Test: Hematology blood test, Diagnostic Test: Biochemistry blood test, Other: NEWS score, Diagnostic Test: PK test, Diagnostic Test: blood test for inflammatory markers, Diagnostic Test: D-dimer test, Other: VAS scale, Diagnostic Test: Urine pregnancy test for women of childbearing potential, Procedure: ECG, Other: COVID-19-Impact on Quality of Life Questionnaire, Drug: CimetrA-1a 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 | Experimental | Diagnostic Test: Confirm SARS-CoV-2 infection, Procedure: Physical Examination, Procedure: Vital Signs, Diagnostic Test: Hematology blood test, Diagnostic Test: Biochemistry blood test, Other: NEWS score, Diagnostic Test: PK test, Diagnostic Test: blood test for inflammatory markers, Diagnostic Test: D-dimer test, Other: VAS scale, Diagnostic Test: Urine pregnancy test for women of childbearing potential, Procedure: ECG, Other: COVID-19-Impact on Quality of Life Questionnaire, Drug: CimetrA-2a 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 comparator | Drug: Placebo administration, Diagnostic Test: Confirm SARS-CoV-2 infection, Procedure: Physical Examination, Procedure: Vital Signs, Diagnostic Test: Hematology blood test, Diagnostic Test: Biochemistry blood test, Other: NEWS score, Diagnostic Test: PK test, Diagnostic Test: blood test for inflammatory markers, Diagnostic Test: D-dimer test, Other: VAS scale, Diagnostic Test: Urine pregnancy test for women of childbearing potential, Procedure: ECG, Other: COVID-19-Impact on Quality of Life Questionnairecomposed 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). |
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 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
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 |
|---|---|---|
| Placebo administrationpatients will receive the placebo treatment in addition to Standard of Care | Drug | Arm 3 - Placebo |
| Confirm SARS-CoV-2 infectionAlso: Covid-19 testpatients will be tested for SARS-CoV-2 on days 1, 14 and 28 | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Physical Examinationpatients will undergo a physical examination on days 1-14 and day 28 | Procedure or surgery | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Vital Signspatient's vital signs will be measured on days 1-14 and day 28 | Procedure or surgery | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Hematology blood testAlso: blood testspatients will provide a blood sample for a hematology blood test on days 1-14 and day 28 | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Biochemistry blood testAlso: blood testspatients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28 | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| NEWS scoreAlso: scoringpatient's NEWS score will be evaluated on days 1-14 and day 28 | Other | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| PK testAlso: pharmacokineticsPK test will be performed on day 1 only (only in Brazil sites) | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| blood test for inflammatory markersAlso: blood testspatients 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 | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| D-dimer testAlso: blood testspatients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28 | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| VAS scaleAlso: scoringpatient's VAS scale will be evaluated on days 1-14, day 21, and day 28 | Other | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| Urine pregnancy test for women of childbearing potentialAlso: pregnancy testpatients will provide a urine sample for a urine pregnancy test on days 1, and day 28 | Diagnostic test | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| ECGpatients will undergo an ECG examination on days 1, and day 28 | Procedure or surgery | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| COVID-19-Impact on Quality of Life Questionnairepatients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28 | Other | Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo |
| CimetrA-1Also: CimetrA-1 drug administrationpatients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care | Drug | Arm 1 - CimetrA-1 |
| CimetrA-2Also: CimetrA- 2 drug administrationpatients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care | Drug | Arm 2 - CimetrA-2 |
Primary outcome
clinical improvement in treatment groups
Time frame: up to 28 days
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)
11 secondary outcomes
oxygen dependency
Time frame: up to 28 days
change in inflammatory marker levels
Time frame: up to day 28
effective dose determination
Time frame: up to 28 days
Pharmacokinetic profile
Time frame: up to 28 days
Pharmacokinetic profile
Time frame: up to 28 days
Pharmacokinetic profile
Time frame: up to 28 days
Incidence 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
evaluation of drug related adverse events
Time frame: up to 28 days
Long term adverse events of COVID-19
Time frame: up to 28 days
Quality of life of patients
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Confirm SARS-CoV-2 infection, Physical Examination and Vital Signs in people with Corona Virus Infection and Covid19, run by MGC Pharmaceuticals d.o.o at 2 sites 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
clinical improvement in treatment groups (time frame: up to 28 days). 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 24 Aug 2022.