Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * participant provides signed informed consent prior to the initiation of any study assessments * has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (\<)10 days prior to randomization * has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility * not on mechanical ventilation or ecmo * has an spo2 less than (\<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (\>=) 150 (or equivalent spo2/fio2 \>=190) with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility * requires hospitalization * other protocol defined inclusion criteria may apply

inclusion criteria: * participant provides signed informed consent prior to the initiation of any study assessments * has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (\<)10 days prior to randomization * has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility * not on mechanical ventilation or ecmo * has an spo2 less than (\<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (\>=) 150 (or equivalent spo2/fio2 \>=190) with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility * requires hospitalization * other protocol defined inclusion criteria may apply

April 6, 2021, 12:31 a.m. usa

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 (or equivalent spo2/fio2 >=190) with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility - requires hospitalization - other protocol defined inclusion criteria may apply

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 (or equivalent spo2/fio2 >=190) with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility - requires hospitalization - other protocol defined inclusion criteria may apply

Dec. 26, 2020, 12:31 a.m. usa

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility - requires hospitalization - other protocol defined inclusion criteria may apply

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility - requires hospitalization - other protocol defined inclusion criteria may apply

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - documented test positive (nat) for sars-cov-2 (based on locally acceptable accepted guidelines) if sampled within 10 days prior to randomization positive for sars-cov-2 based on locally acceptable guidelines (as per locally accepted guidelines) - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 with a maximum fio2 0.4 - requires hospitalization - other protocol defined inclusion criteria may apply

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - documented test positive (nat) for sars-cov-2 (based on locally acceptable accepted guidelines) if sampled within 10 days prior to randomization positive for sars-cov-2 based on locally acceptable guidelines (as per locally accepted guidelines) - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 with a maximum fio2 0.4 - requires hospitalization - other protocol defined inclusion criteria may apply