Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated: females who are pregnant (negative pregnancy test required for all women of child bearing potential at screening) or breast-feeding male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception severe covid-19 disease as defined by the who covid-19 clinical improvement ordinal scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [rrt], extracorporeal membrane oxygenation [ecmo]) expected survival less than 72 hours peripheral capillary oxygen saturation (spo2) <90% while breathing room air treatment with other drugs thought to possibly have activity against sars cov 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently history of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator use of any other concurrent investigational drugs while participating in the present study patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions) known renal disease with an estimated glomerular filtration rate (egfr) <50 ml/min based on local laboratory results patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis alanine transaminase (alt) or aspartate transaminase (ast) >3 × upper limit of normal (uln) or alkaline phosphatase or bilirubin levels > 2 × uln based on local laboratory results co administration of clinical doses of orlistat with dalcetrapib inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., crohn's disease) or malabsorption at screening any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.

patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated: females who are pregnant (negative pregnancy test required for all women of child bearing potential at screening) or breast-feeding male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception severe covid-19 disease as defined by the who covid-19 clinical improvement ordinal scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [rrt], extracorporeal membrane oxygenation [ecmo]) expected survival less than 72 hours peripheral capillary oxygen saturation (spo2) <90% while breathing room air treatment with other drugs thought to possibly have activity against sars cov 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently history of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator use of any other concurrent investigational drugs while participating in the present study patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions) known renal disease with an estimated glomerular filtration rate (egfr) <50 ml/min based on local laboratory results patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis alanine transaminase (alt) or aspartate transaminase (ast) >3 × upper limit of normal (uln) or alkaline phosphatase or bilirubin levels > 2 × uln based on local laboratory results co administration of clinical doses of orlistat with dalcetrapib inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., crohn's disease) or malabsorption at screening any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.

Dec. 23, 2020, 12:31 a.m. usa

- patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated: 1. females who are pregnant (negative pregnancy test required for all women of child bearing potential at screening) or breast-feeding 2. male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception 3. severe covid-19 disease as defined by the who covid-19 clinical improvement ordinal scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [rrt], extracorporeal membrane oxygenation [ecmo]) 4. expected survival less than 72 hours 5. peripheral capillary oxygen saturation (spo2) <90% while breathing room air 6. treatment with other drugs thought to possibly have activity against sars cov 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently 7. history of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator 8. use of any other concurrent investigational drugs while participating in the present study 9. patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions) 10. known renal disease with an estimated glomerular filtration rate (egfr) <50 ml/min based on local laboratory results 11. patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis 12. alanine transaminase (alt) or aspartate transaminase (ast) >3 × upper limit of normal (uln) or alkaline phosphatase or bilirubin levels > 2 × uln based on local laboratory results 13. co administration of clinical doses of orlistat with dalcetrapib 14. inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., crohn's disease) or malabsorption at screening 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study 16. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.

- patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated: 1. females who are pregnant (negative pregnancy test required for all women of child bearing potential at screening) or breast-feeding 2. male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception 3. severe covid-19 disease as defined by the who covid-19 clinical improvement ordinal scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [rrt], extracorporeal membrane oxygenation [ecmo]) 4. expected survival less than 72 hours 5. peripheral capillary oxygen saturation (spo2) <90% while breathing room air 6. treatment with other drugs thought to possibly have activity against sars cov 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently 7. history of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator 8. use of any other concurrent investigational drugs while participating in the present study 9. patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions) 10. known renal disease with an estimated glomerular filtration rate (egfr) <50 ml/min based on local laboratory results 11. patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis 12. alanine transaminase (alt) or aspartate transaminase (ast) >3 × upper limit of normal (uln) or alkaline phosphatase or bilirubin levels > 2 × uln based on local laboratory results 13. co administration of clinical doses of orlistat with dalcetrapib 14. inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., crohn's disease) or malabsorption at screening 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study 16. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.