Status:

COMPLETED

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

Lead Sponsor:

MGC Pharmaceuticals d.o.o

Conditions:

COVID-19

Corona Virus Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Detailed Description

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 infec...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 8 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 21 2020

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04382040

Start Date

May 8 2020

End Date

December 21 2020

Last Update

August 31 2021

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Mahatma Gandhi Mission Medical College and Hospital

Aurangabad, Maharashtra, India, 431 003

2

Hillel Yaffe Medical Center

Hadera, Haifa District, Israel, 3846201

3

Nazareth Hospital EMMS

Nazareth, North, Israel, 16100

4

Rambam Health Care Campus

Haifa, Israel, 3525408