Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19
NCT ID: NCT05037162 Phase: PHASE2 Status: COMPLETED Enrollment: 240 Completion: 2023-03-01
Conditions
Covid19, Corona Virus Infection
Interventions
Biochemistry blood test, Hematology blood test, D-Dimer test (coagulation), Inflammatory markers, Vital signs, VAS scale, WHO Ordinal Score, COVID-19-Related Symptoms assessment, COVID-19-Impact on Quality-of-Life Questionnaire, POST- COVID-19 Functional Status Scale:
Summary
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.
Primary Outcome
Change in WHO Ordinal Scale for clinical improvement