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