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

PHASE3UnknownINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

June 11, 2021

Primary Completion Date

February 28, 2023

Study Completion Date

April 30, 2023

Conditions
Corona Virus InfectionCovid19SARS-CoV Infection
Interventions
DRUG

Placebo administration

patients will receive the placebo treatment in addition to Standard of Care

DIAGNOSTIC_TEST

Confirm SARS-CoV-2 infection

patients will be tested for SARS-CoV-2 on days 1, 14 and 28

PROCEDURE

Physical Examination

patients will undergo a physical examination on days 1-14 and day 28

PROCEDURE

Vital Signs

patient's vital signs will be measured on days 1-14 and day 28

DIAGNOSTIC_TEST

Hematology blood test

patients will provide a blood sample for a hematology blood test on days 1-14 and day 28

DIAGNOSTIC_TEST

Biochemistry blood test

patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28

OTHER

NEWS score

patient's NEWS score will be evaluated on days 1-14 and day 28

DIAGNOSTIC_TEST

PK test

PK test will be performed on day 1 only (only in Brazil sites)

DIAGNOSTIC_TEST

blood test for inflammatory markers

patients will provide a blood sample for an inflammatory markers blood test (IL-6, IL-1β, IL-12, TNF α, IFN-γ) on days 1-7, day 14, and day 28

DIAGNOSTIC_TEST

D-dimer test

patients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28

OTHER

VAS scale

patient's VAS scale will be evaluated on days 1-14, day 21, and day 28

DIAGNOSTIC_TEST

Urine pregnancy test for women of childbearing potential

patients will provide a urine sample for a urine pregnancy test on days 1, and day 28

PROCEDURE

ECG

patients will undergo an ECG examination on days 1, and day 28

OTHER

COVID-19-Impact on Quality of Life Questionnaire

patients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28

DRUG

CimetrA-1

patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care

DRUG

CimetrA-2

patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care

Trial Locations (2)

Unknown

Nazareth Hospital EMMS, Nazareth

Rambam Medical Center, Haifa

Sponsors
All Listed Sponsors
lead

MGC Pharmaceuticals d.o.o

INDUSTRY