Created at | Source | Raw Value | Validated value |
---|---|---|---|
June 25, 2024, noon | usa |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: * receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs * receiving invasive mechanical ventilation * patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) * anticipated survival \<48 hours * underlying malignancy, or other condition, with estimated life expectancy of less than two months * significant pre-existing organ dysfunction prior to randomization * lung: currently receiving home oxygen therapy as documented in medical record * heart: pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record * renal: end-stage renal disease requiring renal replacement therapy or egfr \<30 ml/min * liver: severe chronic liver disease defined as child-pugh class c or ast or alt \>5x upper limit of normal * hematologic: baseline platelet count \<50,000/mm\^3 * presence of co-existing infection, including, but not limited to: * hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm\^3 * active tuberculosis or a history of inadequately treated tuberculosis * active hepatitis b or hepatitis c viral infection * ongoing immunosuppression * solid organ transplant recipient * high-dose corticosteroids (equivalent to \>20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness * oncolytic drug therapy within the past 14 days * current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments * current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir * current enrollment in an interventional trial for covid-19 * history of hypersensitivity or idiosyncratic reaction to ic14 * women who are currently breastfeeding * received a live-attenuated vaccine within 30 days prior to enrollment * received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for covid-19, or * any condition that in the opinion of the treating physician will increase the risk for the participant. |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: * receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs * receiving invasive mechanical ventilation * patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) * anticipated survival \<48 hours * underlying malignancy, or other condition, with estimated life expectancy of less than two months * significant pre-existing organ dysfunction prior to randomization * lung: currently receiving home oxygen therapy as documented in medical record * heart: pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record * renal: end-stage renal disease requiring renal replacement therapy or egfr \<30 ml/min * liver: severe chronic liver disease defined as child-pugh class c or ast or alt \>5x upper limit of normal * hematologic: baseline platelet count \<50,000/mm\^3 * presence of co-existing infection, including, but not limited to: * hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm\^3 * active tuberculosis or a history of inadequately treated tuberculosis * active hepatitis b or hepatitis c viral infection * ongoing immunosuppression * solid organ transplant recipient * high-dose corticosteroids (equivalent to \>20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness * oncolytic drug therapy within the past 14 days * current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments * current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir * current enrollment in an interventional trial for covid-19 * history of hypersensitivity or idiosyncratic reaction to ic14 * women who are currently breastfeeding * received a live-attenuated vaccine within 30 days prior to enrollment * received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for covid-19, or * any condition that in the opinion of the treating physician will increase the risk for the participant. |
March 27, 2021, 12:31 a.m. | usa |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: - receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs - receiving invasive mechanical ventilation - patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) - anticipated survival <48 hours - underlying malignancy, or other condition, with estimated life expectancy of less than two months - significant pre-existing organ dysfunction prior to randomization - lung: currently receiving home oxygen therapy as documented in medical record - heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record - renal: end-stage renal disease requiring renal replacement therapy or egfr <30 ml/min - liver: severe chronic liver disease defined as child-pugh class c or ast or alt >5x upper limit of normal - hematologic: baseline platelet count <50,000/mm^3 - presence of co-existing infection, including, but not limited to: - hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm^3 - active tuberculosis or a history of inadequately treated tuberculosis - active hepatitis b or hepatitis c viral infection - ongoing immunosuppression - solid organ transplant recipient - high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness - oncolytic drug therapy within the past 14 days - current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments - current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir - current enrollment in an interventional trial for covid-19 - history of hypersensitivity or idiosyncratic reaction to ic14 - women who are currently breastfeeding - received a live-attenuated vaccine within 30 days prior to enrollment - received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for covid-19, or - any condition that in the opinion of the treating physician will increase the risk for the participant. |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: - receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs - receiving invasive mechanical ventilation - patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) - anticipated survival <48 hours - underlying malignancy, or other condition, with estimated life expectancy of less than two months - significant pre-existing organ dysfunction prior to randomization - lung: currently receiving home oxygen therapy as documented in medical record - heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record - renal: end-stage renal disease requiring renal replacement therapy or egfr <30 ml/min - liver: severe chronic liver disease defined as child-pugh class c or ast or alt >5x upper limit of normal - hematologic: baseline platelet count <50,000/mm^3 - presence of co-existing infection, including, but not limited to: - hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm^3 - active tuberculosis or a history of inadequately treated tuberculosis - active hepatitis b or hepatitis c viral infection - ongoing immunosuppression - solid organ transplant recipient - high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness - oncolytic drug therapy within the past 14 days - current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments - current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir - current enrollment in an interventional trial for covid-19 - history of hypersensitivity or idiosyncratic reaction to ic14 - women who are currently breastfeeding - received a live-attenuated vaccine within 30 days prior to enrollment - received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for covid-19, or - any condition that in the opinion of the treating physician will increase the risk for the participant. |
Feb. 13, 2021, 12:31 a.m. | usa |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: - receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs - receiving invasive mechanical ventilation - patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) - anticipated survival <48 hours - underlying malignancy, or other condition, with estimated life expectancy of less than two months - significant pre-existing organ dysfunction prior to randomization - lung: currently receiving home oxygen therapy as documented in medical record - heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record - renal: end-stage renal disease requiring renal replacement therapy or egfr <30 ml/min - liver: severe chronic liver disease defined as child-pugh class c or ast or alt >5x upper limit of normal - hematologic: baseline platelet count <50,000/mm^3 - presence of co-existing infection, including, but not limited to: - hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm^3 - active tuberculosis or a history of inadequately treated tuberculosis - active hepatitis b or hepatitis c viral infection - ongoing immunosuppression - solid organ transplant recipient - high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness - oncolytic drug therapy within the past 14 days - current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments - current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir - current enrollment in an interventional trial for covid-19 - history of hypersensitivity or idiosyncratic reaction to ic14 - women who are currently breastfeeding, or - any condition that in the opinion of the treating physician will increase the risk for the participant. |
an individual fulfilling any of the following criteria should be excluded from enrollment in the study: - receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs - receiving invasive mechanical ventilation - patient, surrogate, or physician not committed to full support --exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) - anticipated survival <48 hours - underlying malignancy, or other condition, with estimated life expectancy of less than two months - significant pre-existing organ dysfunction prior to randomization - lung: currently receiving home oxygen therapy as documented in medical record - heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record - renal: end-stage renal disease requiring renal replacement therapy or egfr <30 ml/min - liver: severe chronic liver disease defined as child-pugh class c or ast or alt >5x upper limit of normal - hematologic: baseline platelet count <50,000/mm^3 - presence of co-existing infection, including, but not limited to: - hiv infection not virally suppressed and with pre-hospitalization cd4 counts ≤ 500 cell/mm^3 - active tuberculosis or a history of inadequately treated tuberculosis - active hepatitis b or hepatitis c viral infection - ongoing immunosuppression - solid organ transplant recipient - high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for covid-19 illness - oncolytic drug therapy within the past 14 days - current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actemra®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments - current treatment with an anti-viral medication for covid-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir - current enrollment in an interventional trial for covid-19 - history of hypersensitivity or idiosyncratic reaction to ic14 - women who are currently breastfeeding, or - any condition that in the opinion of the treating physician will increase the risk for the participant. |
Oct. 26, 2020, 11:31 p.m. | usa |
1. intubation 2. receiving non-invasive positive-pressure ventilation 3. receiving invasive mechanical ventilation 4. patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) 5. anticipated survival <48 hours 6. underlying malignancy or other condition with estimated life expectancy of less than one month 7. significant pre-existing organ dysfunction 1. lung: currently receiving home oxygen therapy as documented in medical record 2. heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record 3. renal: end-stage renal disease requiring renal replacement therapy 4. liver: severe chronic liver disease defined as child-pugh class c 8. presence of co-existing infection, including, but not limited to: 1. hiv infection not virally suppressed with cd4 counts ≤ 500 cell/mm3) 2. active tuberculosis or a history of inadequately treated tuberculosis 3. active hepatitis b or hepatitis c viral infection 9. ongoing immunosuppression 1. solid organ transplant recipient 2. high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 14 days 3. oncolytic drug therapy within the past 14 days 10. current treatment, or treatment within 30 days or five half-lives, whichever is longer, with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actrema®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments 11. current enrollment in a pharmacologic interventional trial of host response modifiers 12. concomitant covid-19 antiviral therapy is allowed 13. history of hypersensitivity or idiosyncratic reaction to ic14 |
1. intubation 2. receiving non-invasive positive-pressure ventilation 3. receiving invasive mechanical ventilation 4. patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest) 5. anticipated survival <48 hours 6. underlying malignancy or other condition with estimated life expectancy of less than one month 7. significant pre-existing organ dysfunction 1. lung: currently receiving home oxygen therapy as documented in medical record 2. heart: pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record 3. renal: end-stage renal disease requiring renal replacement therapy 4. liver: severe chronic liver disease defined as child-pugh class c 8. presence of co-existing infection, including, but not limited to: 1. hiv infection not virally suppressed with cd4 counts ≤ 500 cell/mm3) 2. active tuberculosis or a history of inadequately treated tuberculosis 3. active hepatitis b or hepatitis c viral infection 9. ongoing immunosuppression 1. solid organ transplant recipient 2. high-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 14 days 3. oncolytic drug therapy within the past 14 days 10. current treatment, or treatment within 30 days or five half-lives, whichever is longer, with etanercept (enbrel®), infliximab (remicade®), adalimumab (humira®), certolizumab (cimzia®), golimumab (simponi®), anakinra (kineret®), rilonacept (arcalyst®), tocilizumab (actrema®), sarilumab (kevzara®), siltuximab (sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments 11. current enrollment in a pharmacologic interventional trial of host response modifiers 12. concomitant covid-19 antiviral therapy is allowed 13. history of hypersensitivity or idiosyncratic reaction to ic14 |