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

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. 3. participant yields a positive urine pregnancy test at screening. 4. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \[hiv\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin \>1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin \>1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt \>1.5 × uln.

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. 3. participant yields a positive urine pregnancy test at screening. 4. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \[hiv\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin \>1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin \>1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt \>1.5 × uln.

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

at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. participant yields a positive urine pregnancy test at screening. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). has liver impairment greater than child pugh a. has a history of alcohol or drug abuse in the previous 6 months. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. has taken another investigational drug within the past 30 days. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). patient is pregnant or breastfeeding. patients with baseline alt >1.5 × uln.

at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. participant yields a positive urine pregnancy test at screening. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). has liver impairment greater than child pugh a. has a history of alcohol or drug abuse in the previous 6 months. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. has taken another investigational drug within the past 30 days. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). patient is pregnant or breastfeeding. patients with baseline alt >1.5 × uln.

May 22, 2021, 12:32 a.m. usa

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. 3. participant yields a positive urine pregnancy test at screening. 4. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt >1.5 × uln.

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of experimental drugs that may be active against covid-19 in the eyes of the investigators. 3. participant yields a positive urine pregnancy test at screening. 4. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt >1.5 × uln.

April 15, 2021, 12:31 a.m. usa

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of drugs that may be active against covid-19 in the eyes of the investigators. 3. participant has been vaccinated against covid-19 prior to their positive test result. 4. participant yields a positive urine pregnancy test at screening. 5. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 6. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 7. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 8. has liver impairment greater than child pugh a. 9. has a history of alcohol or drug abuse in the previous 6 months. 10. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 11. has taken another investigational drug within the past 30 days. 12. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt >1.5 × uln.

1. at screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of drugs that may be active against covid-19 in the eyes of the investigators. 3. participant has been vaccinated against covid-19 prior to their positive test result. 4. participant yields a positive urine pregnancy test at screening. 5. participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 6. participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 7. has renal insufficiency including severe renal impairment and esrd and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 8. has liver impairment greater than child pugh a. 9. has a history of alcohol or drug abuse in the previous 6 months. 10. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 11. has taken another investigational drug within the past 30 days. 12. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the upper limit of normal (uln) or total bilirubin >1.25 × uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 × uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt >1.5 × uln.

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

1. at screening, the subject needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of drugs that may be active against covid-19 in the eyes of the investigators. 3. subject has any of the following abnormal laboratory test results at screening: 1. platelet count <100,000 cells/mm3 2. absolute leukocyte count < 500 cells/mm3 3. hemoglobin <11 g/dl for women and <12 g/dl for men 4. serum creatinine concentration ≥1.5× uln 5. confirmed creatinine clearance (crcl) < 50 ml/min by cockcroft-gault 4. subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. subject has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the uln or total bilirubin >1.25 x uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 x uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt > 1.5x the upper limit of normal (uln)

1. at screening, the subject needs to be admitted to the hospital or is being evaluated for potential admission. 2. previous use of drugs that may be active against covid-19 in the eyes of the investigators. 3. subject has any of the following abnormal laboratory test results at screening: 1. platelet count <100,000 cells/mm3 2. absolute leukocyte count < 500 cells/mm3 3. hemoglobin <11 g/dl for women and <12 g/dl for men 4. serum creatinine concentration ≥1.5× uln 5. confirmed creatinine clearance (crcl) < 50 ml/min by cockcroft-gault 4. subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). note: treatment of study participants following institutional covid-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. this excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and no, and co-enrollment into other clinical studies that evaluate investigational agents for covid-19. 5. subject has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [hiv], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (capd). 7. has liver impairment greater than child pugh a. 8. has a history of alcohol or drug abuse in the previous 6 months. 9. has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. has taken another investigational drug within the past 30 days. 11. is deemed by the investigator to be ineligible for any reason. additional exclusion criteria for acebilustat protocol: 1. patient has abnormal liver enzyme tests at screening, including ast or alt ≥3 × the uln or total bilirubin >1.25 x uln at screening (patients with known gilbert's syndrome can be included with bilirubin >1.25 x uln). 2. patient is pregnant or breastfeeding. 3. patients with baseline alt > 1.5x the upper limit of normal (uln)