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

NCT04382040 | Completed Phase 2 DMC

• 1 other identifier: MGC-006
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

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.

Conditions

COVID-19; Corona Virus Infection; SARS-CoV 2; Coronavirus; Coronavirus Infection

Keywords

Coronavirus; COVID-19; Intervention Study

Outcome Measures

Primary Outcomes (2)

• Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment

  patient will be assessed using a scoring table for changes in clinical signs

  24 hours

• Percentage of participants with definite or probable drug related adverse events

  Adverse events caused by the study drug will be assessed

  14 days

Secondary Outcomes (7)

• Time to negative COVID-19 PCR

  14 days

• Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

  14 days

• COVID-19 related survival

  14 days

• Incidence and duration of mechanical ventilation

  14 days

• Incidence of Intensive Care Init (ICU) stay

  14 days

Study Arms (2)

ArtemiC

EXPERIMENTAL

Active study treatment + Standard care

Drug: ArtemiC

PLACEBO

PLACEBO COMPARATOR

Placebo + Standard care

Drug: Placebo

Interventions

ArtemiC DRUG

Treatment will be sprayed orally twice a day for the first 2 days in the treatment period

ArtemiC

Placebo DRUG

Treatment will be sprayed orally twice a day for the first 2 days in the treatment period

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MGC Pharmaceuticals d.o.o: lead

Study Sites (4)

Mahatma Gandhi Mission Medical College and Hospital

Aurangabad, Maharashtra, 431 003, India

Location

Hillel Yaffe Medical Center

Hadera, Haifa District, 3846201, Israel

Location

Nazareth Hospital EMMS

Nazareth, North, 16100, Israel

Location

Rambam Health Care Campus

Haifa, 3525408, Israel

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rubi Zomer

  MGC Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 11, 2020
• Study Start: May 8, 2020
• Primary Completion: November 5, 2020
• Study Completion: December 21, 2020
• Last Updated: August 31, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); IL (3)