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

inclusion criteria: * confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). * currently hospitalized. * informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). * has symptoms of severe covid-19 as demonstrated by: * at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. * clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: sao2 \<92% on room air in last 12 hours or requires \> 4 liters per minute (lpm) oxygen by nasal canula, non-rebreather/ventimask or high flow nasal canula in order maintain sao2 ≥92%, pao2/fio2 \<300 millimeter per mercury (mm/hg). * elevated c-reactive protein (crp) \> 2 x upper limit of normal (uln). * concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. * female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

inclusion criteria: * confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). * currently hospitalized. * informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). * has symptoms of severe covid-19 as demonstrated by: * at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. * clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: sao2 \<92% on room air in last 12 hours or requires \> 4 liters per minute (lpm) oxygen by nasal canula, non-rebreather/ventimask or high flow nasal canula in order maintain sao2 ≥92%, pao2/fio2 \<300 millimeter per mercury (mm/hg). * elevated c-reactive protein (crp) \> 2 x upper limit of normal (uln). * concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. * female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

Nov. 2, 2021, 12:30 p.m. usa

inclusion criteria: - confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). - currently hospitalized. - informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - has symptoms of severe covid-19 as demonstrated by: - at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. - clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: sao2 <92% on room air in last 12 hours or requires > 4 liters per minute (lpm) oxygen by nasal canula, non-rebreather/ventimask or high flow nasal canula in order maintain sao2 ≥92%, pao2/fio2 <300 millimeter per mercury (mm/hg). - elevated c-reactive protein (crp) > 2 x upper limit of normal (uln). - concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

inclusion criteria: - confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). - currently hospitalized. - informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - has symptoms of severe covid-19 as demonstrated by: - at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. - clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: sao2 <92% on room air in last 12 hours or requires > 4 liters per minute (lpm) oxygen by nasal canula, non-rebreather/ventimask or high flow nasal canula in order maintain sao2 ≥92%, pao2/fio2 <300 millimeter per mercury (mm/hg). - elevated c-reactive protein (crp) > 2 x upper limit of normal (uln). - concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

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

inclusion criteria: - confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). - currently hospitalized. - informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - has symptoms of severe covid-19 as demonstrated by: - at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. - clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: respiratory rate ≥ 30 breaths/minute (min), heart rate ≥ 125/min, sao2 <93% on room air or requires > 2 liter (l) oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 millimeter per mercury (mm/hg). - concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgement, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

inclusion criteria: - confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). - currently hospitalized. - informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - has symptoms of severe covid-19 as demonstrated by: - at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. - clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: respiratory rate ≥ 30 breaths/minute (min), heart rate ≥ 125/min, sao2 <93% on room air or requires > 2 liter (l) oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 millimeter per mercury (mm/hg). - concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgement, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.