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

1. treatment with imv or ecmo (niaid-os 7); 2. hepatic dysfunction: alt or ast \> 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); 3. renal dysfunction: estimated glomerular filtration rate (egfr, mdrd) \<50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; 4. current use of \>2 immunosuppressive medications or immunosuppression status (aids, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (anc \< local lln), solid organ or bone marrow transplant recipients) 5. treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period (see section 5.5.2); 6. anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening 7. history of: 1. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) 2. lactase deficiency, galactosemia or glucose-galactose malabsorption 3. gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage 4. allergy to reparixin or any component of the imp formulation 8. active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage 9. participation in other interventional clinical trials 10. clinical condition not compatible with oral administration of the study drug 11. pregnancy: 1. positive or missing pregnancy test before first drug intake or day 1; 2. pregnant or lactating women; 3. women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study 12. current hospital stay \>72h 13. complicated cap-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

1. treatment with imv or ecmo (niaid-os 7); 2. hepatic dysfunction: alt or ast \> 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); 3. renal dysfunction: estimated glomerular filtration rate (egfr, mdrd) \<50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; 4. current use of \>2 immunosuppressive medications or immunosuppression status (aids, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (anc \< local lln), solid organ or bone marrow transplant recipients) 5. treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period (see section 5.5.2); 6. anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening 7. history of: 1. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) 2. lactase deficiency, galactosemia or glucose-galactose malabsorption 3. gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage 4. allergy to reparixin or any component of the imp formulation 8. active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage 9. participation in other interventional clinical trials 10. clinical condition not compatible with oral administration of the study drug 11. pregnancy: 1. positive or missing pregnancy test before first drug intake or day 1; 2. pregnant or lactating women; 3. women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study 12. current hospital stay \>72h 13. complicated cap-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Oct. 17, 2022, 12:34 p.m. usa

treatment with imv or ecmo (niaid-os 7); hepatic dysfunction: alt or ast > 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); renal dysfunction: estimated glomerular filtration rate (egfr, mdrd) <50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; current use of >2 immunosuppressive medications or immunosuppression status (aids, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (anc < local lln), solid organ or bone marrow transplant recipients) treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period (see section 5.5.2); anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening history of: intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) lactase deficiency, galactosemia or glucose-galactose malabsorption gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage allergy to reparixin or any component of the imp formulation active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage participation in other interventional clinical trials clinical condition not compatible with oral administration of the study drug pregnancy: positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study current hospital stay >72h complicated cap-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

treatment with imv or ecmo (niaid-os 7); hepatic dysfunction: alt or ast > 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); renal dysfunction: estimated glomerular filtration rate (egfr, mdrd) <50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; current use of >2 immunosuppressive medications or immunosuppression status (aids, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (anc < local lln), solid organ or bone marrow transplant recipients) treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period (see section 5.5.2); anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening history of: intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) lactase deficiency, galactosemia or glucose-galactose malabsorption gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage allergy to reparixin or any component of the imp formulation active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage participation in other interventional clinical trials clinical condition not compatible with oral administration of the study drug pregnancy: positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study current hospital stay >72h complicated cap-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Feb. 25, 2022, 7 p.m. usa

treatment with imv or ecmo (niaid-os 7); hepatic dysfunction: alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); renal dysfunction: estimated glomerular filtration rate (estimated glomerular filtration rate, modification of diet in renal disease study equation) <50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; pao2/fio2 ratio < 100 mmhg; treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period; anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening history of: intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) lactase deficiency, galactosemia or glucose-galactose malabsorption gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage participation in other interventional clinical trials clinical condition not compatible with oral administration of the study drug pregnancy: positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study

treatment with imv or ecmo (niaid-os 7); hepatic dysfunction: alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 uln; history of chronic hepatic disease (defined with child-pugh score b or c); renal dysfunction: estimated glomerular filtration rate (estimated glomerular filtration rate, modification of diet in renal disease study equation) <50 ml/min/1.73 m2, or need for haemodialysis or hemofiltration; pao2/fio2 ratio < 100 mmhg; treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period; anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening history of: intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) lactase deficiency, galactosemia or glucose-galactose malabsorption gastrointestinal bleeding or perforation due to previous nsaids therapy or recurrent peptic ulcer/haemorrhage active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage participation in other interventional clinical trials clinical condition not compatible with oral administration of the study drug pregnancy: positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study