Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

INCLUSION CRITERIA: 1. Male and female patients aged 19-85 years of age, inclusive, as of baseline/screening visit2. Confirmed coronavirus infection based on possessing at least one of the following etiologicalevidence: a. Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory orblood specimens for COVID-19 nucleic acid b. Viral gene sequences in respiratory or blood specimens that are highly homologous toCOVID-19 c. Any other diagnostic test accepted by local regulatory authorities 3. Presence of severe pneumonia as evidenced by any of the following: a. Respiratory distress with RR &gt,=30 breaths/minuteb. SpO2 &lt,90&#37, on room air and at restc. PaO2/FiO2 =&lt, 250 mmHg (1mmHg = 0.133kPa) 4. Chest imaging (x-ray [XR] or computerized tomography [CT]) confirms severe pneumonia ANDshows evidence of inflammatory exudation or pleural effusion 5. Female patients of childbearing potential who are sexually active with a non-sterilized malepartner must use at least 1 highly effective method of contraception from the time of screeningand must agree to continue using such precautions for 90 days after the final dose of studydrug(s) 6. Non-sterilized males who are sexually active with a female partner of childbearing potential mustuse condom plus spermicide from day 1 through 90 days after receipt of the last dose of studydrug(s) Patients (or their legal designates), must have the capacity to understand, sign and date a voluntarywritten, informed consent form and any required authorization prior to initiation of any studyprocedure.

INCLUSION CRITERIA: 1. Male and female patients aged 19-85 years of age, inclusive, as of baseline/screening visit2. Confirmed coronavirus infection based on possessing at least one of the following etiologicalevidence: a. Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory orblood specimens for COVID-19 nucleic acid b. Viral gene sequences in respiratory or blood specimens that are highly homologous toCOVID-19 c. Any other diagnostic test accepted by local regulatory authorities 3. Presence of severe pneumonia as evidenced by any of the following: a. Respiratory distress with RR &gt,=30 breaths/minuteb. SpO2 &lt,90&#37, on room air and at restc. PaO2/FiO2 =&lt, 250 mmHg (1mmHg = 0.133kPa) 4. Chest imaging (x-ray [XR] or computerized tomography [CT]) confirms severe pneumonia ANDshows evidence of inflammatory exudation or pleural effusion 5. Female patients of childbearing potential who are sexually active with a non-sterilized malepartner must use at least 1 highly effective method of contraception from the time of screeningand must agree to continue using such precautions for 90 days after the final dose of studydrug(s) 6. Non-sterilized males who are sexually active with a female partner of childbearing potential mustuse condom plus spermicide from day 1 through 90 days after receipt of the last dose of studydrug(s) Patients (or their legal designates), must have the capacity to understand, sign and date a voluntarywritten, informed consent form and any required authorization prior to initiation of any studyprocedure.