240
Participants
Start Date
October 11, 2022
Primary Completion Date
January 21, 2023
Study Completion Date
March 1, 2023
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,
Hematology blood test
preformed on days 1-14 and day 28. complete CBC.
D-Dimer test (coagulation)
performed on days 1,2,7,14 and 28.
Inflammatory markers
performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ
Vital signs
performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.
VAS scale
performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.
WHO Ordinal Score
performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.
COVID-19-Related Symptoms assessment
performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.
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.
POST- COVID-19 Functional Status Scale:
performed on day 28. score: 0-3 ; a higher score indicates better recovery.
Pregnancy test
performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.
Physical examination
performed on days 1-14 and day 28. a full examination by a doctor.
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)"
SARS-CoV-2 test (PCR)
performed on days 1,14 and 28.
ECG
performed on days 1 and 28.
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)
Rambam Medical Center, Haifa
Lead Sponsor
MGC Pharmaceuticals d.o.o
INDUSTRY