COVID-19Phase 2NCT04382040
A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
A Phase 2 study testing ArtemiC in people with COVID-19 and Corona Virus Infection, run by MGC Pharmaceuticals d.o.o at 4 sites in 2 countries.
Trial summary
Agent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Corona Virus Infection, SARS-CoV 2
- What is being tested?
- ArtemiC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 May 2020to 21 Dec 2020
- 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 SARS-CoV-2 infection.
- Hospitalized COVID-19 patient in stable moderate condition (i.e., not requiring ICU admission).
- Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
Who cannot join
- Tube feeding or parenteral nutrition.
- Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening.
- Respiratory decompensation requiring mechanical ventilation.
- Uncontrolled diabetes type 2.
- Autoimmune disease.
- Pregnant or lactating women.
- 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
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Hillel Yaffe Medical Center
Hadera, Haifa District, 3846201
Rambam Health Care Campus
Haifa, 3525408
Nazareth Hospital EMMS
Nazareth, North, 16100
India1 site
Mahatma Gandhi Mission Medical College and Hospital
Aurangabad, Maharashtra, 431 003
About this study
Agent Name and Study Duration
ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration.
Read more
Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care.
Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events.
Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy.
Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2.
Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. 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.
Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities.
Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19.
Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19.
Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care.
Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
Read the detailed description
STUDY OBJECTIVES This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19.
STUDY TREATMENT AND DESIGN 50 adult patients who suffer from COVID-19 infection, and do not participant in any other clinical trial.
Patient must agree to not participate in any new clinical study during the study duration.
ArtemiC is a medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration.
It has a current status as a food supplement. Patients will receive up to 12 mg Artemisinin, 40 mg Curcumin, 30 mg Frankincense and 120 mg vitamin C in 2ml as a total maximum dose, given as add-on therapy, comprised of 2 daily doses of 0.5 ml each, on Days 1 and 2. Each dose contains 0.5 ml (total 1 ml daily dose), which is equal to 5 pushes on the spray bottle.
Placebo, composed of the same solvent but without active ingredients, will be given as add-on therapy in the placebo group, 2 times a day, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care.
The study will last 2 weeks. During this time, patients will be monitored for adverse events.
Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy.
STUDY PROCEDURES
Evaluation of the effect of oral administration of the study drug will be assessed by determining the clinical and laboratory tests as summarized below:
Biochemistry Blood Test: 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, LDL, Triglycerides), D-dimer, ESR as well as Troponin as required.It will be performed per institutional schedule.
Hematology Blood Test: complete CBC. It will be performed per institutional schedule.
Vital signs: blood pressure, pulse, weight, height, temperature. It will be performed per institutional schedule.
Women of childbearing potential must undergo a urine pregnancy test. Physical examination: It will be performed per institutional schedule. All the above measurements will be performed by the hospital staff, not necessarily by the principal investigator or the sub-investigators.
Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a declination), and review and sign an ICF. Following procedures will be performed during the visit -
- Inclusion/Exclusion criteria evaluation
- ICF
- Medical history
- Concomitant medication
- Physical examination
- Vital signs
- Urine pregnancy test (if relevant)
- Test for detection of COVID-19
- Hematology blood test
- Biochemistry blood test
- Randomization (2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care) and study drug administration
Day 2
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Hematology blood test
- Biochemistry blood test
- Study drug administration
Days 3-14
- Concomitant medication
- Adverse Events assessment
- Physical examination-is per institutional schedule
- Vital signs- is per institutional schedule
- Hematology blood test- is per institutional schedule
- Biochemistry blood test- is per institutional schedule
Follow up - Hospital Discharge
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Test for detection COVID-19
- Hematology blood test
- Biochemistry blood test
- Conditions
- COVID-19, Corona Virus Infection, SARS-CoV 2, Coronavirus, Coronavirus Infection
- Being tested
- ArtemiC, Placebo
- Keywords
- Coronavirus, COVID-19, Intervention Study
- 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.
ArtemiCDrug
Treatment will be sprayed orally twice a day for the first 2 days in the treatment period
PlaceboDrug
Treatment will be sprayed orally twice a day for the first 2 days in the treatment period
| Study group | Role | What they receive |
|---|---|---|
| ArtemiC | Experimental | Active study treatment + Standard care Receives: Drug: ArtemiC |
| PLACEBO | Placebo comparator | Placebo + Standard care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment
patient will be assessed using a scoring table for changes in clinical signs
Measured: 24 hours
Percentage of participants with definite or probable drug related adverse events
Adverse events caused by the study drug will be assessed
Measured: 14 days
Secondary outcomes (7)
Time to negative COVID-19 PCR
Measured: 14 days
Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms
Measured: 14 days
COVID-19 related survival
Measured: 14 days
Incidence and duration of mechanical ventilation
Measured: 14 days
Incidence of Intensive Care Init (ICU) stay
Measured: 14 days
Duration of ICU stay
Measured: 14 days
Duration of time on supplemental oxygen
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start8 May 2020
- Primary completion5 Nov 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient study period will last 2 weeks. During this time, patients will be monitored for adverse events. There will be a follow up period (until hospital discharge) in order to check side effects and study drug efficacy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGC Pharmaceuticals d.o.o
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubi Zomer, Study director, MGC Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382040
- Sponsor's protocol ID
- MGC-006
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04382040
- Acronym / sponsor ID
- MGC-006
- Conditions
- COVID-19, Corona Virus Infection, SARS-CoV 2, Coronavirus, Coronavirus Infection
- Keywords
- Coronavirus, COVID-19, Intervention Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MGC Pharmaceuticals d.o.oIndustry (pharma, biotech, devices)
- Study start
- 8 May 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 11 May 2020 (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.
Agent Name and Study Duration
ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration.
Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care.
Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events.
Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy.
Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2.
Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. 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.
Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities.
Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19.
Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19.
Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care.
Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
Detailed description
STUDY OBJECTIVES This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19.
STUDY TREATMENT AND DESIGN 50 adult patients who suffer from COVID-19 infection, and do not participant in any other clinical trial.
Patient must agree to not participate in any new clinical study during the study duration.
ArtemiC is a medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration.
It has a current status as a food supplement. Patients will receive up to 12 mg Artemisinin, 40 mg Curcumin, 30 mg Frankincense and 120 mg vitamin C in 2ml as a total maximum dose, given as add-on therapy, comprised of 2 daily doses of 0.5 ml each, on Days 1 and 2. Each dose contains 0.5 ml (total 1 ml daily dose), which is equal to 5 pushes on the spray bottle.
Placebo, composed of the same solvent but without active ingredients, will be given as add-on therapy in the placebo group, 2 times a day, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care.
The study will last 2 weeks. During this time, patients will be monitored for adverse events.
Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy.
STUDY PROCEDURES
Evaluation of the effect of oral administration of the study drug will be assessed by determining the clinical and laboratory tests as summarized below:
Biochemistry Blood Test: 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, LDL, Triglycerides), D-dimer, ESR as well as Troponin as required.It will be performed per institutional schedule.
Hematology Blood Test: complete CBC. It will be performed per institutional schedule.
Vital signs: blood pressure, pulse, weight, height, temperature. It will be performed per institutional schedule.
Women of childbearing potential must undergo a urine pregnancy test. Physical examination: It will be performed per institutional schedule. All the above measurements will be performed by the hospital staff, not necessarily by the principal investigator or the sub-investigators.
Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a declination), and review and sign an ICF. Following procedures will be performed during the visit -
- Inclusion/Exclusion criteria evaluation
- ICF
- Medical history
- Concomitant medication
- Physical examination
- Vital signs
- Urine pregnancy test (if relevant)
- Test for detection of COVID-19
- Hematology blood test
- Biochemistry blood test
- Randomization (2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care) and study drug administration
Day 2
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Hematology blood test
- Biochemistry blood test
- Study drug administration
Days 3-14
- Concomitant medication
- Adverse Events assessment
- Physical examination-is per institutional schedule
- Vital signs- is per institutional schedule
- Hematology blood test- is per institutional schedule
- Biochemistry blood test- is per institutional schedule
Follow up - Hospital Discharge
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Test for detection COVID-19
- Hematology blood test
- Biochemistry blood test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient study period will last 2 weeks. During this time, patients will be monitored for adverse events. There will be a follow up period (until hospital discharge) in order to check side effects and study drug efficacy
| Arm | Type | Receives |
|---|---|---|
| ArtemiC | Experimental | Drug: ArtemiCActive study treatment + Standard care |
| PLACEBO | Placebo comparator | Drug: PlaceboPlacebo + Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed SARS-CoV-2 infection.
- Hospitalized COVID-19 patient in stable moderate condition (i.e., not requiring ICU admission).
- Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
Key exclusion criteria (7 listed)
- Tube feeding or parenteral nutrition.
- Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening.
- Respiratory decompensation requiring mechanical ventilation.
- Uncontrolled diabetes type 2.
- Autoimmune disease.
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 |
|---|---|---|
| ArtemiCTreatment will be sprayed orally twice a day for the first 2 days in the treatment period | Drug | ArtemiC |
| PlaceboTreatment will be sprayed orally twice a day for the first 2 days in the treatment period | Drug | PLACEBO |
Primary outcome
Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment
Time frame: 24 hours
patient will be assessed using a scoring table for changes in clinical signs
Percentage of participants with definite or probable drug related adverse events
Time frame: 14 days
Adverse events caused by the study drug will be assessed
7 secondary outcomes
Time to negative COVID-19 PCR
Time frame: 14 days
Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms
Time frame: 14 days
COVID-19 related survival
Time frame: 14 days
Incidence and duration of mechanical ventilation
Time frame: 14 days
Incidence of Intensive Care Init (ICU) stay
Time frame: 14 days
Duration of ICU stay
Time frame: 14 days
Duration of time on supplemental oxygen
Time frame: 14 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 31 Aug 2021.
- 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.
Rubi Zomer study director
MGC Pharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ArtemiC in people with COVID-19 and Corona Virus Infection, run by MGC Pharmaceuticals d.o.o at 4 sites in 2 countries.
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 3 inclusion and 7 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, India. 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?
Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment (time frame: 24 hours). The study lists 2 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 31 Aug 2021.