Clinical trial
A Phase IIb, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
Name
MGC-009
Description
Multi-center multinational-controlled study in Israel, Brazil, Spain, and South-Africa.
240 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
After Screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo) in addition to Standard of Care- Arm 3.
Trial arms
Trial start
2022-10-11
Estimated PCD
2023-01-21
Trial end
2023-03-01
Status
Completed
Phase
Early phase I
Treatment
Biochemistry blood test
preformed on days 1-14 and day 28. 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,
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Hematology blood test
preformed on days 1-14 and day 28. complete CBC.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
D-Dimer test (coagulation)
performed on days 1,2,7,14 and 28.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Inflammatory markers
performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Vital signs
performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
VAS scale
performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
WHO Ordinal Score
performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
COVID-19-Related Symptoms assessment
performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
COVID-19-Impact on Quality-of-Life Questionnaire
performed on days 1,7,14,21 and 28. score: 1-5 ; a higher score indicates a lower quality of life.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
POST- COVID-19 Functional Status Scale:
performed on day 28. score: 0-3 ; a higher score indicates better recovery.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Pregnancy test
performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Physical examination
performed on days 1-14 and day 28. a full examination by a doctor.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
PK parameters
performed on day 1. will be performed only on 14 patients that will agree to participate in the PK analysis (only for Brazil,Spain).
The PK will be performed only for the first dose of drug, after patient received the first dose (5 puffs) the study staff need to follow the table below.
For each test, approximately 5 ml of blood will be drawn (equivalent to one teaspoon)
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
SARS-CoV-2 test (PCR)
performed on days 1,14 and 28.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
ECG
performed on days 1 and 28.
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Treatment administration (twice a day)
performed on days 1 and 2. twice a day, morning, and evening 1:1:1 ratio to study drug (CimetrA-1) (Arm 1) or study drug (CimetrA-2) or to Placebo (Arm 3)
Arms:
Arm 1 - CimetrA-1, Arm 2 - CimetrA-2, Arm 3 - Placebo
Size
240
Primary endpoint
Change in WHO Ordinal Scale for clinical improvement
up to 28 days
Change in COVID-19-Related Symptoms score
up to 28 days
Safety endpoint: will be assessed through collection and analysis of adverse events
up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood laboratory test.
up to 28 days
Safety endpoint: will be assessed through collection and analysis of urine laboratory test.
up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood preasure
up to 28 days
Safety endpoint: will be assessed through collection and analysis of blood satturation
up to 28 days
Safety endpoint: will be assessed through collection and analysis of body temperature
up to 28 days
Eligibility criteria
Inclusion Criteria:
1. Confirmed by PCR test SARS-CoV-2 infection (according to nationally authorized laboratory criteria)
2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission (defined by NIH criteria - fever, cough, dyspnea, fast breathing, but no signs of severe pneumonia, including SpO2 ≥ 94% on room air).
3. Age: 18 years old and above.
4. Subjects must be hospitalized
5. Ability to receive treatment by spray into the oral cavity
Exclusion Criteria:
1. Tube feeding or parenteral nutrition.
2. Patients with scores 5 or above per the Ordinal Scale for Clinical Improvement published by the WHO. (i.e., who need oxygen supply beyond use of nozzles or simple mask)
3. Need for admission to ICU during the present hospitalization at any time prior to completion of the recruitment to the study.
4. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-center multinational-controlled study in Israel, Brazil, Spain, and South-Africa.\n\n240 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.\n\nAfter Screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo) in addition to Standard of Care- Arm 3.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "This is a double-blind study: neither the participants nor the investigators will be aware of arm allocation of each study participant.\n\nBlindness is important to avoid bias. Monitoring and reporting of the success of blindness are important for the reader's confidence of the trial results. Groups should be marked by capital letter and blindness should maintain throughout the study.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ACTUAL'}}
Updated at
2023-03-15
1 organization
1 product
2 indications
Organization
MGC PharmaceuticalsProduct
Treatment administrationIndication
COVID-19Indication
Coronavirus Infection