Created at Source Raw Value Validated value
May 12, 2022, 6 p.m. eu

Patients meeting any of the following criteria will be excluded from the study: 1.Patient with current serious condition meeting one of the following criteria: a.Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.. b.Respiratory distress with respiratory rate ≥ 30 breaths/min. c.Requires supplemental oxygen. d.Experience shock. e.Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion. 2.Patient who has received or has a plan to receive any of following prohibited medications or treatments: a.Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine (unless used chronically for autoimmune diseases), dexamethasone, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration. b.Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration. c.Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration. d.Use of medications that are contraindicated with SoC. e.SARS-CoV-2 vaccine prior to the study drug administration. 3.Patient has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug. 4.Patient who has a current or history of any of the following infections: a.Any active infection other than SARS-CoV-2 requiring systemic treatment. b.Documented current infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. c.Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization. 5.Patient who has a medical condition including one or more of the following at Screening: a.Any uncontrolled clinically significant respiratory disease in the investigator’s opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma). b.Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal c.Renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. d.History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study drug administration. e.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study. f. Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator. g. Any active malignancy. h. Currently immunocompromised, whether due to underlying medical condition (e.g., malignancy, transplantation) or medical therapy (e.g., medications, chemotherapy, radiation). i. Any co-morbidity requiring surgery within <7 days prior to the study drug administration, or that is considered life threatening within 30 days prior to study drug administration. j. Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage) k. Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator. l. Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms.

Patients meeting any of the following criteria will be excluded from the study: 1.Patient with current serious condition meeting one of the following criteria: a.Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.. b.Respiratory distress with respiratory rate ≥ 30 breaths/min. c.Requires supplemental oxygen. d.Experience shock. e.Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion. 2.Patient who has received or has a plan to receive any of following prohibited medications or treatments: a.Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine (unless used chronically for autoimmune diseases), dexamethasone, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration. b.Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration. c.Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration. d.Use of medications that are contraindicated with SoC. e.SARS-CoV-2 vaccine prior to the study drug administration. 3.Patient has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug. 4.Patient who has a current or history of any of the following infections: a.Any active infection other than SARS-CoV-2 requiring systemic treatment. b.Documented current infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. c.Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization. 5.Patient who has a medical condition including one or more of the following at Screening: a.Any uncontrolled clinically significant respiratory disease in the investigator’s opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma). b.Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal c.Renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. d.History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study drug administration. e.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study. f. Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator. g. Any active malignancy. h. Currently immunocompromised, whether due to underlying medical condition (e.g., malignancy, transplantation) or medical therapy (e.g., medications, chemotherapy, radiation). i. Any co-morbidity requiring surgery within <7 days prior to the study drug administration, or that is considered life threatening within 30 days prior to study drug administration. j. Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage) k. Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator. l. Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms.