A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
Status:
Completed
Trial end date:
2020-12-21
Target enrollment:
Participant gender:
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.