252
Participants
Start Date
June 11, 2021
Primary Completion Date
February 28, 2023
Study Completion Date
April 30, 2023
Placebo administration
patients will receive the placebo treatment in addition to Standard of Care
Confirm SARS-CoV-2 infection
patients will be tested for SARS-CoV-2 on days 1, 14 and 28
Physical Examination
patients will undergo a physical examination on days 1-14 and day 28
Vital Signs
patient's vital signs will be measured on days 1-14 and day 28
Hematology blood test
patients will provide a blood sample for a hematology blood test on days 1-14 and day 28
Biochemistry blood test
patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28
NEWS score
patient's NEWS score will be evaluated on days 1-14 and day 28
PK test
PK test will be performed on day 1 only (only in Brazil sites)
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
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
VAS scale
patient's VAS scale will be evaluated on days 1-14, day 21, and day 28
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
ECG
patients will undergo an ECG examination on days 1, and day 28
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
CimetrA-1
patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care
CimetrA-2
patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care
Nazareth Hospital EMMS, Nazareth
Rambam Medical Center, Haifa
Lead Sponsor
MGC Pharmaceuticals d.o.o
INDUSTRY