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

subjects who meet any of the following criteria will be excluded from participation in the study: 1. unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. 2. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months 3. uncontrolled bacterial, fungal, or non-covid viral infection 4. active tb 5. any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) 6. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 7. receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom 8. history of hypersensitivity to tocilizumab 9. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 10. treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents 11. treatment with convalescent plasma 12. history of diverticulitis or bowel perforation 13. anc \<500, platelets \<50,000\* 14. ast/alt \> 5x uln 15. women who are pregnant or planning to get pregnant in the next 90 days; 16. any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; 17. any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.

subjects who meet any of the following criteria will be excluded from participation in the study: 1. unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. 2. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months 3. uncontrolled bacterial, fungal, or non-covid viral infection 4. active tb 5. any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) 6. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 7. receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom 8. history of hypersensitivity to tocilizumab 9. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 10. treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents 11. treatment with convalescent plasma 12. history of diverticulitis or bowel perforation 13. anc \<500, platelets \<50,000\* 14. ast/alt \> 5x uln 15. women who are pregnant or planning to get pregnant in the next 90 days; 16. any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; 17. any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.

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

subjects who meet any of the following criteria will be excluded from participation in the study: unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months uncontrolled bacterial, fungal, or non-covid viral infection active tb any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom history of hypersensitivity to tocilizumab any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents treatment with convalescent plasma history of diverticulitis or bowel perforation anc <500, platelets <50,000* ast/alt > 5x uln women who are pregnant or planning to get pregnant in the next 90 days; any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.

subjects who meet any of the following criteria will be excluded from participation in the study: unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months uncontrolled bacterial, fungal, or non-covid viral infection active tb any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom history of hypersensitivity to tocilizumab any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents treatment with convalescent plasma history of diverticulitis or bowel perforation anc <500, platelets <50,000* ast/alt > 5x uln women who are pregnant or planning to get pregnant in the next 90 days; any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.

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

subjects who meet any of the following criteria will be excluded from participation in the study: 1. unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. 2. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months 3. uncontrolled bacterial, fungal, or non-covid viral infection 4. active tb 5. any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) 6. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 7. receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom 8. history of hypersensitivity to tocilizumab 9. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 10. treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents 11. treatment with convalescent plasma 12. history of diverticulitis or bowel perforation 13. anc <500, platelets <50,000* 14. ast/alt > 5x uln 15. women who are pregnant or planning to get pregnant in the next 90 days; 16. any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; 17. any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.

subjects who meet any of the following criteria will be excluded from participation in the study: 1. unable to provide verbal informed consent or have verbal agreement to participate through attestation and signature of a witness required, as outlined in the partners irb's table for consenting in covid research that is more than minimal risk. 2. subjects between the ages of 79 and 86 will be excluded if they have nyha class iii/iv heart failure, insulin-dependent diabetes mellitus, angina, or treatment of a malignancy (excluding non-melanoma skin cancer) within six months 3. uncontrolled bacterial, fungal, or non-covid viral infection 4. active tb 5. any prior investigational immunosuppressive therapy within 28-days or 3 half-lives of the agent (for instance with biologic or jak inhibitor) 6. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 7. receipt of intravenous tocilizumab for the treatment of a non-covid condition within three weeks of the first covid symptom 8. history of hypersensitivity to tocilizumab 9. any concurrent immunosuppressive medication that the pi believes would put the patient at higher risk 10. treatment with other biologic or small-molecule immunosuppressive therapy such as il1r-antagonism, jak inhibition, or other agents 11. treatment with convalescent plasma 12. history of diverticulitis or bowel perforation 13. anc <500, platelets <50,000* 14. ast/alt > 5x uln 15. women who are pregnant or planning to get pregnant in the next 90 days; 16. any condition that could interfere with, or for known allergy to the study drug or any of its ingredients or known allergy to any other anti il 6 agents; 17. any condition that could interfere with or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the subject by participating in the study. we note that anti-viral therapies may be administered to subjects if given in the context of a clinical trial. nitric oxide treatment is also permitted at the discretion of the care team, ideally in the context of a clinical trial. co-treatment chloroquine, hydroxychloroquine, and/or azithromycin is permitted for subjects in this protocol.