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

1. off label use of other drugs 2. wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner 3. pregnant women 4. pancytopenia 1. hgb\< 8 g/dl (male) or \< 7 g/dl (female) 2. wbc\<2.0 x 109/l 3. plt\< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

1. off label use of other drugs 2. wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner 3. pregnant women 4. pancytopenia 1. hgb\< 8 g/dl (male) or \< 7 g/dl (female) 2. wbc\<2.0 x 109/l 3. plt\< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

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

off label use of other drugs wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner pregnant women pancytopenia hgb< 8 g/dl (male) or < 7 g/dl (female) wbc<2.0 x 109/l plt< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

off label use of other drugs wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner pregnant women pancytopenia hgb< 8 g/dl (male) or < 7 g/dl (female) wbc<2.0 x 109/l plt< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

Aug. 23, 2021, 7 p.m. usa

1. off label use of other drugs 2. wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner 3. pregnant women 4. pancytopenia 1. hgb< 8 g/dl (male) or < 7 g/dl (female) 2. wbc<2.0 x 109/l 3. plt< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

1. off label use of other drugs 2. wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner 3. pregnant women 4. pancytopenia 1. hgb< 8 g/dl (male) or < 7 g/dl (female) 2. wbc<2.0 x 109/l 3. plt< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation