Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Patients must meet all inclusion criteria to be eligible for study Participation. <br/ > <br/ > 1. Willing and able to provide written informed consent, or with alegal representative who can provide informed consent, or <br/ > enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator prior to performing study procedures <br/ > 2. Male or female patients aged between 45 to 60 years, both <br/ > inclusive, with gender balance ensured through stratification upon randomization. <br/ > 3. Patient has COVID-19 symptoms less than or equal to 10 days with moderate <br/ > severity including any of the following consistent with classification of moderate disease severity: <br/ > O2 saturation (SpO2) 90 percent to less than or equal to93 percent on room air or <br/ > Respiratory rate greater than or equal to 24 per min, breathlessness <br/ > 4. Patients with score of 5 on WHO ordinal scale for clinical <br/ > improvement [non-invasive ventilation or high-flow oxygen] <br/ > Note: Patients admitted with immediate need for mechanical <br/ > ventilation are of a severity too critical for inclusion into this <br/ > protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible. <br/ > 5. Vaccination status for COVID-19 will not influence eligibility for the study. <br/ > 6. Patient laboratory-confirmed COVID-19 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following: <br/ > Patient has a SARS-CoV-2 PCR positive sample collected less than 72 hours prior to randomization <br/ > Patient has a SARS-CoV-2 PCR positive sample collected greater than or equal to72 hours prior to randomization, with a documented inability to obtain a repeat sample (e.g., due to lack of testing supplies, limited testing capacity, results taking greater than24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 pneumonia. <br/ > 7. Patient understands and agrees to comply with planned study procedures. <br/ > 8. Patient agrees to be placed on a prophylactic dose of <br/ > anticoagulation medication for prevention of deep venous <br/ > thrombosis (DVT) while hospitalized <br/ > 9. Patients who are women of childbearing potential must have a negative pregnancy test <br/ > <br/ >

Patients must meet all inclusion criteria to be eligible for study Participation. <br/ > <br/ > 1. Willing and able to provide written informed consent, or with alegal representative who can provide informed consent, or <br/ > enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator prior to performing study procedures <br/ > 2. Male or female patients aged between 45 to 60 years, both <br/ > inclusive, with gender balance ensured through stratification upon randomization. <br/ > 3. Patient has COVID-19 symptoms less than or equal to 10 days with moderate <br/ > severity including any of the following consistent with classification of moderate disease severity: <br/ > O2 saturation (SpO2) 90 percent to less than or equal to93 percent on room air or <br/ > Respiratory rate greater than or equal to 24 per min, breathlessness <br/ > 4. Patients with score of 5 on WHO ordinal scale for clinical <br/ > improvement [non-invasive ventilation or high-flow oxygen] <br/ > Note: Patients admitted with immediate need for mechanical <br/ > ventilation are of a severity too critical for inclusion into this <br/ > protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible. <br/ > 5. Vaccination status for COVID-19 will not influence eligibility for the study. <br/ > 6. Patient laboratory-confirmed COVID-19 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following: <br/ > Patient has a SARS-CoV-2 PCR positive sample collected less than 72 hours prior to randomization <br/ > Patient has a SARS-CoV-2 PCR positive sample collected greater than or equal to72 hours prior to randomization, with a documented inability to obtain a repeat sample (e.g., due to lack of testing supplies, limited testing capacity, results taking greater than24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 pneumonia. <br/ > 7. Patient understands and agrees to comply with planned study procedures. <br/ > 8. Patient agrees to be placed on a prophylactic dose of <br/ > anticoagulation medication for prevention of deep venous <br/ > thrombosis (DVT) while hospitalized <br/ > 9. Patients who are women of childbearing potential must have a negative pregnancy test <br/ > <br/ >