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

inclusion criteria: 1. males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. 2. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. 3. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. 4. subject (or their legally authorized representative \[lar\]) is willing and able to provide written informed consent. 5. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. 6. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 \< 300. 7. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. 8. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) \> upper limit of normal \[uln\] at screening.

inclusion criteria: 1. males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. 2. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. 3. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. 4. subject (or their legally authorized representative \[lar\]) is willing and able to provide written informed consent. 5. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. 6. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 \< 300. 7. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. 8. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) \> upper limit of normal \[uln\] at screening.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. subject (or their legally authorized representative [lar]) is willing and able to provide written informed consent. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 < 300. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) > upper limit of normal [uln] at screening.

inclusion criteria: males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. subject (or their legally authorized representative [lar]) is willing and able to provide written informed consent. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 < 300. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) > upper limit of normal [uln] at screening.

July 31, 2021, 1 p.m. usa

inclusion criteria: 1. males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. 2. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. 3. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. 4. subject (or their legally authorized representative [lar]) is willing and able to provide written informed consent. 5. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. 6. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 < 300. 7. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. 8. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) > upper limit of normal [uln] at screening.

inclusion criteria: 1. males or females ≥ 18 years of age hospitalized with severe covid-19, who are within 2 weeks of symptom onset. 2. laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test (naat) from an upper respiratory specimen within 72 hours of randomization. test type and result must be documented in the study record. 3. subject agrees to the collection and processing of blood and saliva samples, non-invasive oxygen monitoring (via pulse oximeter), nasal speculum examination, and radiography (high-resolution ct scanning) as required in the protocol. 4. subject (or their legally authorized representative [lar]) is willing and able to provide written informed consent. 5. has at least 2 of the following symptoms for ≥ 48 hours: fever or history of fever (oral temp ≥ 38°c), cough, headache, fatigue, muscle aches, gastrointestinal symptoms, and/or shortness of breath. 6. respiratory rate ≥ 30 per minute, spo2 ≤ 93% on room air at sea level, heart rate ≥ 125/min, and/or pao2/fio2 < 300. 7. radiologic evidence of pneumonia (infiltrates on high-resolution ct) at screening. 8. erythrocyte sedimentation rate (esr), crp and/or lactate dehydrogenase (ldh) > upper limit of normal [uln] at screening.