Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

* evidence of acute respiratory distress syndrome (ards), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen \>= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) * shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) * evidence of multi-organ dysfunction/failure * pre-existing acute or chronic liver disease * patients with indolent local malignancies or pre-malignant conditions including but not limited to: * smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (mgus) * basal or squamous cell carcinoma of the skin * carcinoma in situ of the cervix or breast * incidental histologic finding of prostate cancer (t1a or t1b using the tumor node metastasis \[tnm\] clinical staging system) or prostate cancer that is curative * history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * secondary bacterial, fungal, or viral infections that are not adequately controlled * any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * if human immunodeficiency virus (hiv)-positive: cd4+ t cell count \< 200 * positive for tuberculosis antigen (e.g., t-spot test) * presence of liver metastasis * gastrointestinal (gi) malignancies associated with malabsorption and inability to take cholestyramine * steroids, except for low-dose replacement or high-dose for management of acute symptoms such as ards * any new immunosuppressive medication in the 4 weeks prior to enrollment, excepting agents used for treatment of covid-19 that may also have immunosuppressive properties * medications that are cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists, if these medications are not approved by the investigator. cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists that are approved by the investigator are allowed * concurrent administration of live vaccines * prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

* evidence of acute respiratory distress syndrome (ards), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen \>= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) * shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) * evidence of multi-organ dysfunction/failure * pre-existing acute or chronic liver disease * patients with indolent local malignancies or pre-malignant conditions including but not limited to: * smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (mgus) * basal or squamous cell carcinoma of the skin * carcinoma in situ of the cervix or breast * incidental histologic finding of prostate cancer (t1a or t1b using the tumor node metastasis \[tnm\] clinical staging system) or prostate cancer that is curative * history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * secondary bacterial, fungal, or viral infections that are not adequately controlled * any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * if human immunodeficiency virus (hiv)-positive: cd4+ t cell count \< 200 * positive for tuberculosis antigen (e.g., t-spot test) * presence of liver metastasis * gastrointestinal (gi) malignancies associated with malabsorption and inability to take cholestyramine * steroids, except for low-dose replacement or high-dose for management of acute symptoms such as ards * any new immunosuppressive medication in the 4 weeks prior to enrollment, excepting agents used for treatment of covid-19 that may also have immunosuppressive properties * medications that are cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists, if these medications are not approved by the investigator. cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists that are approved by the investigator are allowed * concurrent administration of live vaccines * prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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

- evidence of acute respiratory distress syndrome (ards), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen >= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) - shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) - evidence of multi-organ dysfunction/failure - pre-existing acute or chronic liver disease - patients with indolent local malignancies or pre-malignant conditions including but not limited to: - smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (mgus) - basal or squamous cell carcinoma of the skin - carcinoma in situ of the cervix or breast - incidental histologic finding of prostate cancer (t1a or t1b using the tumor node metastasis [tnm] clinical staging system) or prostate cancer that is curative - history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent - secondary bacterial, fungal, or viral infections that are not adequately controlled - any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures - if human immunodeficiency virus (hiv)-positive: cd4+ t cell count < 200 - positive for tuberculosis antigen (e.g., t-spot test) - presence of liver metastasis - gastrointestinal (gi) malignancies associated with malabsorption and inability to take cholestyramine - steroids, except for low-dose replacement or high-dose for management of acute symptoms such as ards - any new immunosuppressive medication in the 4 weeks prior to enrollment, excepting agents used for treatment of covid-19 that may also have immunosuppressive properties - medications that are cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists, if these medications are not approved by the investigator. cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists that are approved by the investigator are allowed - concurrent administration of live vaccines - prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

- evidence of acute respiratory distress syndrome (ards), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen >= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) - shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) - evidence of multi-organ dysfunction/failure - pre-existing acute or chronic liver disease - patients with indolent local malignancies or pre-malignant conditions including but not limited to: - smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (mgus) - basal or squamous cell carcinoma of the skin - carcinoma in situ of the cervix or breast - incidental histologic finding of prostate cancer (t1a or t1b using the tumor node metastasis [tnm] clinical staging system) or prostate cancer that is curative - history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent - secondary bacterial, fungal, or viral infections that are not adequately controlled - any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures - if human immunodeficiency virus (hiv)-positive: cd4+ t cell count < 200 - positive for tuberculosis antigen (e.g., t-spot test) - presence of liver metastasis - gastrointestinal (gi) malignancies associated with malabsorption and inability to take cholestyramine - steroids, except for low-dose replacement or high-dose for management of acute symptoms such as ards - any new immunosuppressive medication in the 4 weeks prior to enrollment, excepting agents used for treatment of covid-19 that may also have immunosuppressive properties - medications that are cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists, if these medications are not approved by the investigator. cyp1a2 inducers, cyp2c8 inhibitors, and vitamin k antagonists that are approved by the investigator are allowed - concurrent administration of live vaccines - prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)