Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04382040 |
| Other study ID # |
MGC-006 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2020 |
| Est. completion date |
December 21, 2020 |
Study information
| Verified date |
May 2020 |
| Source |
MGC Pharmaceuticals d.o.o |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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
