A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

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

Inclusion criteria

• 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).

Exclusion criteria

• 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.