Created at Source Raw Value Validated value
Oct. 17, 2022, 10:36 a.m. usa

medical conditions - active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift known active tuberculosis participants with acquired immune deficiency syndrome it is not in the best interest of the participants to participate, in the opinion of the treating investigator. in the opinion of the investigator, progression to death was imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. female participants who were pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention excluded prior/concomitant therapy - prior treatment with other agents with actual or possible direct acting anti-inflammatory activity against sars-cov-2 in the past 30 days (for example, chloroquine, hydroxychloroquine) treatment with convalescent plasma treatment with high doses of corticosteroids (greater than 20 milligrams daily, prednisone equivalent) prior to randomization treatment with immunomodulators including anti-interleukin (il)-6, anti-il-6 receptor antagonists, or with janus kinase inhibitors in the past 30 days or plans to receive during the study period previous exposure to study intervention or any other agent targeting colony stimulating factor-1 or csf-1r or known allergy/sensitivity to study intervention

medical conditions - active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift known active tuberculosis participants with acquired immune deficiency syndrome it is not in the best interest of the participants to participate, in the opinion of the treating investigator. in the opinion of the investigator, progression to death was imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. female participants who were pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention excluded prior/concomitant therapy - prior treatment with other agents with actual or possible direct acting anti-inflammatory activity against sars-cov-2 in the past 30 days (for example, chloroquine, hydroxychloroquine) treatment with convalescent plasma treatment with high doses of corticosteroids (greater than 20 milligrams daily, prednisone equivalent) prior to randomization treatment with immunomodulators including anti-interleukin (il)-6, anti-il-6 receptor antagonists, or with janus kinase inhibitors in the past 30 days or plans to receive during the study period previous exposure to study intervention or any other agent targeting colony stimulating factor-1 or csf-1r or known allergy/sensitivity to study intervention

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

subjects are excluded from the study if any of the following criteria apply: medical conditions active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift. known active tuberculosis (tb). subjects with acquired immune deficiency syndrome (aids). it is not in the best interest of the subjects to participate, in the opinion of the treating investigator. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention. excluded prior/concomitant therapy prior treatment with other agents with actual or possible direct acting anti inflammatory activity against sars-cov-2 in the past 30 days (e.g. chloroquine, hydroxychloroquine). treatment with convalescent plasma. treatment with high doses of corticosteroids (greater than 20 mg daily, prednisone equivalent) prior to randomization. treatment with immunomodulators including anti-il 6, anti-il-6 receptor antagonists, or with janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period. previous exposure to study intervention or any other agent targeting csf-1 or csf 1r or known allergy/sensitivity to study intervention.

subjects are excluded from the study if any of the following criteria apply: medical conditions active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift. known active tuberculosis (tb). subjects with acquired immune deficiency syndrome (aids). it is not in the best interest of the subjects to participate, in the opinion of the treating investigator. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention. excluded prior/concomitant therapy prior treatment with other agents with actual or possible direct acting anti inflammatory activity against sars-cov-2 in the past 30 days (e.g. chloroquine, hydroxychloroquine). treatment with convalescent plasma. treatment with high doses of corticosteroids (greater than 20 mg daily, prednisone equivalent) prior to randomization. treatment with immunomodulators including anti-il 6, anti-il-6 receptor antagonists, or with janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period. previous exposure to study intervention or any other agent targeting csf-1 or csf 1r or known allergy/sensitivity to study intervention.

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

subjects are excluded from the study if any of the following criteria apply: medical conditions 1. active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift. 2. known active tuberculosis (tb). 3. subjects with acquired immune deficiency syndrome (aids). 4. it is not in the best interest of the subjects to participate, in the opinion of the treating investigator. 5. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 6. female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention. excluded prior/concomitant therapy 7. prior treatment with other agents with actual or possible direct acting anti inflammatory activity against sars-cov-2 in the past 30 days (e.g. chloroquine, hydroxychloroquine). 8. treatment with convalescent plasma. 9. treatment with high doses of corticosteroids (greater than 20 mg daily, prednisone equivalent) prior to randomization. 10. treatment with immunomodulators including anti-il 6, anti-il-6 receptor antagonists, or with janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period. 11. previous exposure to study intervention or any other agent targeting csf-1 or csf 1r or known allergy/sensitivity to study intervention.

subjects are excluded from the study if any of the following criteria apply: medical conditions 1. active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift. 2. known active tuberculosis (tb). 3. subjects with acquired immune deficiency syndrome (aids). 4. it is not in the best interest of the subjects to participate, in the opinion of the treating investigator. 5. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 6. female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention. excluded prior/concomitant therapy 7. prior treatment with other agents with actual or possible direct acting anti inflammatory activity against sars-cov-2 in the past 30 days (e.g. chloroquine, hydroxychloroquine). 8. treatment with convalescent plasma. 9. treatment with high doses of corticosteroids (greater than 20 mg daily, prednisone equivalent) prior to randomization. 10. treatment with immunomodulators including anti-il 6, anti-il-6 receptor antagonists, or with janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period. 11. previous exposure to study intervention or any other agent targeting csf-1 or csf 1r or known allergy/sensitivity to study intervention.