• Received a SARS-CoV-2 vaccine
• Patient with current serious condition meeting one of the following criteria: a) Previously or currently hospitalized or requiring hospitalization for treatment of serious COVID-19–related conditions (severe disease as defined in the World Health Organization Guidance, 2020), b)Respiratory distress with respiratory rate ≥30 breaths/min, c) Requiring supplemental oxygen, d)Experiencing shock, e)Complication with other organ failure, and intensive care unit monitoring treatment needed per investigator’s discretion
• Patient who had received or planned to receive any of following prohibited medications or treatments: a) Drugs with actual or possible antiviral drugs and/or possible anti–COVID-19 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and HIV protease inhibitors (lopinavir-ritonavir, etc.) for the treatment of COVID-19 prior to study drug administration, b) Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 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 COVID-19 prior to study drug administration, d) Use of medications that are contraindicated with standard of care, e)COVID-19 vaccine prior to study drug administration
• Patient had known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug
• Patient who had a current or history of any of the following infections: a)Any active infection other than COVID-19 requiring systemic treatment, b)Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization
• Patient who had a medical condition including one or more of the following at screening: a)Any comorbidity requiring surgery within <7 days prior to study drug administration, or that was considered life threatening within 30 days prior to study drug administration, b)Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage), c) Patient showed evidence of a condition (psychological, emotional problems, any disorders, or resultant therapy) that was 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, d) 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
• Anticipated transfer to another hospital that was not a study site
• Patient who abused alcohol or drugs or had a history of alcohol or drug abuse within 12 months prior to study drug administration
• Patient who had received any other investigational device or medical product within 4 weeks prior to study drug administration or 5 half-lives, whichever was longer
• Patient who, in the opinion of the investigator, was not likely to complete the study for whatever reason other than criteria listed above
• Patient who, in the opinion of their general practitioner or the investigator, should not participate in the study
• Female patient who was pregnant or breastfeeding or planning to be pregnant or to breastfeed, or male patient who was planning to father a child or donate sperms throughout the study (up to 6 months after study drug administration)

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

N