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

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ClinicalTrials.gov Identifier: NCT04382040
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
MGC Pharmaceuticals d.o.o

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 in a nanoparticular formulation, 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.


Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection SARS-CoV 2 Coronavirus Coronavirus Infection Drug: ArtemiC Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ArtemiC
Active study treatment + Standard care
Drug: ArtemiC
Treatment will be sprayed orally twice a day for the first 2 days in the treatment period

Placebo Comparator: PLACEBO
Placebo + Standard care
Drug: Placebo
Treatment will be sprayed orally twice a day for the first 2 days in the treatment period




Primary Outcome Measures :
  1. Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment [ Time Frame: 24 hours ]
    patient will be assessed using a scoring table for changes in clinical signs

  2. Percentage of participants with definite or probable drug related adverse events [ Time Frame: 14 days ]
    Adverse events caused by the study drug will be assessed


Secondary Outcome Measures :
  1. Time to negative COVID-19 PCR [ Time Frame: 14 days ]
  2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms [ Time Frame: 14 days ]
  3. COVID-19 related survival [ Time Frame: 14 days ]
  4. Incidence and duration of mechanical ventilation [ Time Frame: 14 days ]
  5. Incidence of Intensive Care Init (ICU) stay [ Time Frame: 14 days ]
  6. Duration of ICU stay [ Time Frame: 14 days ]
  7. Duration of time on supplemental oxygen [ Time Frame: 14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed SARS-CoV-2 infection.
  2. Hospitalized COVID-19 patient in stable moderate condition (i.e., not requiring ICU admission).
  3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).

Exclusion Criteria:

  1. Tube feeding or parenteral nutrition.
  2. Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening.
  3. Respiratory decompensation requiring mechanical ventilation.
  4. Uncontrolled diabetes type 2.
  5. Autoimmune disease.
  6. Pregnant or lactating women.
  7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382040


Contacts
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Contact: Nadia Lisovoder +972529573063 nadyal@galilee-cbr.com

Locations
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Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Haifa, Israel, 3846201
Contact: Ilana Aloni       ilanaa@hy.health.gov.il   
Contact: Jamil Muhsan       jamilm@hy.health.gov.il   
Nazareth Hospital EMMS Recruiting
Nazareth, North, Israel, 16100
Contact: Ameer Elemy       ameer.elemy@gmail.com   
Contact: Elias       eliasgh@gmail.com   
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 3525408
Contact: Shadi Hamoud, MD    +972523591876    s_hamoud@rambam.health.gov.il   
Sponsors and Collaborators
MGC Pharmaceuticals d.o.o
Investigators
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Study Director: Rubi Zomer MGC Pharmaceuticals
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Responsible Party: MGC Pharmaceuticals d.o.o
ClinicalTrials.gov Identifier: NCT04382040    
Other Study ID Numbers: MGC-006
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MGC Pharmaceuticals d.o.o:
Coronavirus
COVID-19
Intervention Study
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases