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

Summary

Participation Requirements

Description

The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located...

The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule. 252 adult patients who suffer from COVID-19 infection and do not participate in any other clinical trial. The patient must not agree to participate in any new clinical study during the study duration. The study will take place during the patient's hospitalization due to a COVID-19 infection. The study will last up to 4 weeks, until the conclusion on day 28. In case of hospital discharge within the study period, follow-up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule. Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a signed declination), and review and sign an ICF. Following procedures will be performed during the visit - Inclusion/Exclusion criteria evaluation Informed Consent Medical History Concomitant Medications Physical Examination Vital Signs Hematology blood test (local, mandatory even if there are available results from the day before) Biochemistry blood test (local, mandatory even if there are available results from the day before) NEWS score PK test (brazil only, central)* Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) D-Dimer test (local) VAS scale Urine pregnancy test for women of childbearing potential ECG COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer) Randomization in 1:1:1 ratio to study drug (CimetrA) in addition to Standard of Care (Arm 1 (CimetrA-1) or Arm 2 (CimetrA-2)) or Placebo in addition to Standard of Care (Arm 3) Treatment administration (twice a day, morning and evening) Test for detection COVID-19 (within 5 days from admission to hospital) Day 2 Concomitant Medications AE Assessment Physical Examination Vital Signs Hematology blood test (local, mandatory even if there are available results from the day before) Biochemistry blood test (local, mandatory even if there are available results from the day before) NEWS score Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) D-Dimer test (local) VAS scale Treatment administration (twice a day, morning and evening) Days 3-6 Concomitant Medications AE assessment Physical Examination Vital Signs Hematology blood test ** Biochemistry blood test ** News score ** Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) VAS scale Day 7 Concomitant Medications AE assessment Physical Examination Vital Signs Hematology blood test (local, mandatory even if there are available results from the day before) Biochemistry blood test (local, mandatory even if there are available results from the day before) News score Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) D-Dimer test (local) VAS scale COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer) Days 8-13 Concomitant Medications AE assessment Physical Examination Vital Signs Hematology blood test ** Biochemistry blood test ** News score ** VAS scale Day 14 Concomitant Medications AE assessment Physical Examination Vital Signs Hematology blood test (local, mandatory even if there are available results from the day before) Biochemistry blood test (local, mandatory even if there are available results from the day before) News score Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) D-Dimer test (local) VAS scale Test for detection COVID-19 COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer) Day 21 (phone visit) Concomitant Medications AE assessment VAS scale COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer) Day 28 - Follow Up (clinic visit) Concomitant Medications AE assessment Physical Examination Vital Signs Hematology blood test (local, mandatory even if there are available results from the day before) Biochemistry blood test (local, mandatory even if there are available results from the day before) News score Blood test for inflammatory markers (IL-6, IL-1?, IL-12, TNF ?, IFN-?) (local) D-Dimer test (local) VAS scale Test for detection COVID-19 Urine pregnancy test for women of childbearing potential ECG COVID-19-Impact on Quality of Life Questionnaire (will be completed by the staff based on the patient answer)

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