A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 : 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 PROCEDURESEvaluation 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 evaluationICFMedical historyConcomitant medicationPhysical examinationVital signsUrine pregnancy test (if relevant)Test for detection of COVID-19Hematology blood testBiochemistry blood testRandomization (2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care) and study drug administrationDay 2Concomitant medicationAdverse Events assessmentPhysical examinationVital signsHematology blood testBiochemistry blood testStudy drug administrationDays 3-14Concomitant medicationAdverse Events assessmentPhysical examination-is per institutional scheduleVital signs- is per institutional scheduleHematology blood test- is per institutional scheduleBiochemistry blood test- is per institutional scheduleFollow up - Hospital DischargeConcomitant medicationAdverse Events assessmentPhysical examinationVital signsTest for detection COVID-19Hematology blood testBiochemistry blood test.

Medienart:	Klinische Studie

Erscheinungsjahr:	2021
Erschienen:	2021

Enthalten in:	ClinicalTrials.gov - (2021) vom: 31. Aug. Zur Gesamtaufnahme - year:2021

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Communicable Diseases Coronavirus Infections Infection Medical Condition: COVID-19, Corona Virus Infection, SARS-CoV 2, Coronavirus, Coronavirus Infection Phase: Phase 2 Recruitment Status: Completed Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: May 11, 2020, Last downloaded: ClinicalTrials.gov processed this data on September 13, 2021, Last updated: September 15, 2021

Study ID:	NCT04382040 MGC-006
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PPN (Katalog-ID):	CTG003386945