Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

October 11, 2022

Primary Completion Date

January 21, 2023

Study Completion Date

March 1, 2023

Conditions
Covid19Corona Virus Infection
Interventions
DIAGNOSTIC_TEST

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,

DIAGNOSTIC_TEST

Hematology blood test

preformed on days 1-14 and day 28. complete CBC.

DIAGNOSTIC_TEST

D-Dimer test (coagulation)

performed on days 1,2,7,14 and 28.

DIAGNOSTIC_TEST

Inflammatory markers

performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ

DIAGNOSTIC_TEST

Vital signs

performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.

DIAGNOSTIC_TEST

VAS scale

performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.

DIAGNOSTIC_TEST

WHO Ordinal Score

performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.

DIAGNOSTIC_TEST

COVID-19-Related Symptoms assessment

performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

POST- COVID-19 Functional Status Scale:

performed on day 28. score: 0-3 ; a higher score indicates better recovery.

DIAGNOSTIC_TEST

Pregnancy test

performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.

DIAGNOSTIC_TEST

Physical examination

performed on days 1-14 and day 28. a full examination by a doctor.

DIAGNOSTIC_TEST

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)"

DIAGNOSTIC_TEST

SARS-CoV-2 test (PCR)

performed on days 1,14 and 28.

DIAGNOSTIC_TEST

ECG

performed on days 1 and 28.

DRUG

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)

Trial Locations (1)

Unknown

Rambam Medical Center, Haifa

Sponsors
All Listed Sponsors
lead

MGC Pharmaceuticals d.o.o

INDUSTRY