Created at Source Raw Value Validated value
March 27, 2021, 12:31 a.m. usa

None

None

Oct. 27, 2020, 11:31 p.m. usa

1. subjects participating in studies for covid-19 other than convalescent plasma or anticoagulation protocol, such as immunomodulating drugs, will be excluded. 2. subject is currently participating in another study with an investigational new drug or device. participation in observational studies is allowed. 3. known hypersensitivity to anakinra or e. coli derived proteins. 4. existence of other evidence that can explain pneumonia including but not limited to: influenza a virus, influenza b virus, bacterial pneumonia, fungal pneumonia, or mycobacterial infection. 5. hematologic abnormalities such as neutropenia (anc < 1 x 109/l) or thrombocytopenia (platelet counts < 50x109/l). 6. subjects with known human immunodeficiency virus (hiv) infection. a. cytokine expression is altered in many patients with hiv infection.25 in addition, some anti-hiv drugs have off-target effects on the immune system function. since the focus of treatment with anakinra is the modulation of inflammation due to covid-19 and hiv patients may have hiv-related mechanisms inducing inflammation, including those patients, could confound the interpretation of the effects of anakinra. 7. poor performance status, such as bed-bound and poor cognition prior to hospitalization. 8. culture confirmed active bacterial infection requiring antibiotic therapy. 9. subjects who are: do not intubate (dni) and/or do not resuscitate (dnr) will not be allowed in the study. 10. subjects already on mechanical ventilation or on extracorporeal membrane oxygenation (ecmo). 11. subjects with life expectancy ≤ 24 hours. 12. subjects with poor performance status prior to admission to the hospital. 13. subjects with cancer on chemotherapy or immunotherapy. 14. subjects receiving other immunosuppressant biologics. 15. pregnant or breast-feeding females. 16. subjects who are already using the following medications will not be allowed: - tumor necrosis alpha inhibitors: use on any of these biologics within 8 weeks of screening or baseline visit. - il-6 inhibitors: use of any il-6 inhibitors within 8 weeks of screening or baseline visit - janus kinase inhibitors: use of baricitinib, tofacinitib, upadacitinib, and ruxolitinib, oclacitinib, fedratinib, within 2 weeks from screening or baseline visit. - bruton's tyrosine kinase inhibitors: ibrutinib, acalabrutinib, zanubrutinib - ccr5 antagonist (ccr5 = c-c chemokine receptor type 5; dmard = disease modifying anti-rheumatic drug): leronlimab is also an immunomodulator. - dmards - cyclosporine, cyclophosphamide, mycophenolic acid, chlorambucil, penicillamine, azathioprine: use within 6 months prior to screening or baseline visit. - rituximab: use of rituximab within 1 year of screening or baseline visit. - abatacept: use of abatacept within 8 weeks of screening or baseline visit.

1. subjects participating in studies for covid-19 other than convalescent plasma or anticoagulation protocol, such as immunomodulating drugs, will be excluded. 2. subject is currently participating in another study with an investigational new drug or device. participation in observational studies is allowed. 3. known hypersensitivity to anakinra or e. coli derived proteins. 4. existence of other evidence that can explain pneumonia including but not limited to: influenza a virus, influenza b virus, bacterial pneumonia, fungal pneumonia, or mycobacterial infection. 5. hematologic abnormalities such as neutropenia (anc < 1 x 109/l) or thrombocytopenia (platelet counts < 50x109/l). 6. subjects with known human immunodeficiency virus (hiv) infection. a. cytokine expression is altered in many patients with hiv infection.25 in addition, some anti-hiv drugs have off-target effects on the immune system function. since the focus of treatment with anakinra is the modulation of inflammation due to covid-19 and hiv patients may have hiv-related mechanisms inducing inflammation, including those patients, could confound the interpretation of the effects of anakinra. 7. poor performance status, such as bed-bound and poor cognition prior to hospitalization. 8. culture confirmed active bacterial infection requiring antibiotic therapy. 9. subjects who are: do not intubate (dni) and/or do not resuscitate (dnr) will not be allowed in the study. 10. subjects already on mechanical ventilation or on extracorporeal membrane oxygenation (ecmo). 11. subjects with life expectancy ≤ 24 hours. 12. subjects with poor performance status prior to admission to the hospital. 13. subjects with cancer on chemotherapy or immunotherapy. 14. subjects receiving other immunosuppressant biologics. 15. pregnant or breast-feeding females. 16. subjects who are already using the following medications will not be allowed: - tumor necrosis alpha inhibitors: use on any of these biologics within 8 weeks of screening or baseline visit. - il-6 inhibitors: use of any il-6 inhibitors within 8 weeks of screening or baseline visit - janus kinase inhibitors: use of baricitinib, tofacinitib, upadacitinib, and ruxolitinib, oclacitinib, fedratinib, within 2 weeks from screening or baseline visit. - bruton's tyrosine kinase inhibitors: ibrutinib, acalabrutinib, zanubrutinib - ccr5 antagonist (ccr5 = c-c chemokine receptor type 5; dmard = disease modifying anti-rheumatic drug): leronlimab is also an immunomodulator. - dmards - cyclosporine, cyclophosphamide, mycophenolic acid, chlorambucil, penicillamine, azathioprine: use within 6 months prior to screening or baseline visit. - rituximab: use of rituximab within 1 year of screening or baseline visit. - abatacept: use of abatacept within 8 weeks of screening or baseline visit.