A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
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ClinicalTrials.gov Identifier: NCT04382040 |
Recruitment Status :
Completed
First Posted : May 11, 2020
Last Update Posted : August 31, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | May 7, 2020 | ||||
First Posted Date ICMJE | May 11, 2020 | ||||
Last Update Posted Date | August 31, 2021 | ||||
Actual Study Start Date ICMJE | May 8, 2020 | ||||
Actual Primary Completion Date | November 5, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 | ||||
Official Title ICMJE | A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 | ||||
Brief 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. 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. |
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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 -
Day 2
Days 3-14
Follow up - Hospital Discharge
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 21, 2020 | ||||
Actual Primary Completion Date | November 5, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | India, Israel | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04382040 | ||||
Other Study ID Numbers ICMJE | MGC-006 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | MGC Pharmaceuticals d.o.o | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | MGC Pharmaceuticals d.o.o | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | MGC Pharmaceuticals d.o.o | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |