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

* non-hospitalized patients, including those requiring home oxygen support * patient has a creatinine clearance \< 50 ml/min/1.73m\^2 using the modification of diet in renal disease formula * patient cannot take the study drug by mouth and needs to be administered by nasogastric tube at screening. * patient has a known allergy to any study medication or macrolides * patient with known medical history of hepatitis b or, if tested, presence of hepatitis b surface antigen at screening * patient has a known medical history of hepatitis c or positive hepatitis c antibody test result at screening (if obtained) * patient has a positive hepatitis c rna test result at screening * patient has a known medical history of human immunodeficiency virus (hiv) infection or was seropositive for human immunodeficiency virus (if tested) * patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening * patient has used a macrolide in the week prior to screening * patient has used antiviral drugs which are not part of soc \< 24 hours prior to day 1 * patient receiving hemoperfusion or with anticipated use of hemoperfusion (including when hemoperfusion is a part of soc) * patient has used the following types of medications \< 2 days prior to day 1 and/or plans to initiate such medications during the treatment period without an appropriate alternative therapy: 1. narrow therapeutic index substrates of cytochrome p450 (cyp) enzymes 2. narrow therapeutic index substrates of major transporters: organic anion transporting polypeptide 1b1 and 1b3 (oatp1b1, oatp1b3), organic anion transporter 1 and 3 (oat1, oat3), organic cation transporter 2 (oct2) and multidrug and toxin extrusion proteins 1 and 2-k (mate1, mate2k) 3. strong inhibitors and/or inducers of enzymes cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, cyp3a4/5 4. strong inhibitors of transporters oatp1b1 and oatp1b3 5. note: strong inhibitors of oat1/oat3, oct2 and mate1/mate2k should be avoided when possible, but when unavoidable investigators may assess the risks and benefits and to continue treatment with such medications under close observation for adverse events * patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects * patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 * female patient who is pregnant or breastfeeding * critical patient with a life expectancy \< 48 hours * patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation * patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock * patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening * patient has a mean corrected qt interval using fridericia's formula (qtcf) of \> 450 msec (for male patients) and \> 470 msec (for female patients) at screening * patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

* non-hospitalized patients, including those requiring home oxygen support * patient has a creatinine clearance \< 50 ml/min/1.73m\^2 using the modification of diet in renal disease formula * patient cannot take the study drug by mouth and needs to be administered by nasogastric tube at screening. * patient has a known allergy to any study medication or macrolides * patient with known medical history of hepatitis b or, if tested, presence of hepatitis b surface antigen at screening * patient has a known medical history of hepatitis c or positive hepatitis c antibody test result at screening (if obtained) * patient has a positive hepatitis c rna test result at screening * patient has a known medical history of human immunodeficiency virus (hiv) infection or was seropositive for human immunodeficiency virus (if tested) * patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening * patient has used a macrolide in the week prior to screening * patient has used antiviral drugs which are not part of soc \< 24 hours prior to day 1 * patient receiving hemoperfusion or with anticipated use of hemoperfusion (including when hemoperfusion is a part of soc) * patient has used the following types of medications \< 2 days prior to day 1 and/or plans to initiate such medications during the treatment period without an appropriate alternative therapy: 1. narrow therapeutic index substrates of cytochrome p450 (cyp) enzymes 2. narrow therapeutic index substrates of major transporters: organic anion transporting polypeptide 1b1 and 1b3 (oatp1b1, oatp1b3), organic anion transporter 1 and 3 (oat1, oat3), organic cation transporter 2 (oct2) and multidrug and toxin extrusion proteins 1 and 2-k (mate1, mate2k) 3. strong inhibitors and/or inducers of enzymes cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, cyp3a4/5 4. strong inhibitors of transporters oatp1b1 and oatp1b3 5. note: strong inhibitors of oat1/oat3, oct2 and mate1/mate2k should be avoided when possible, but when unavoidable investigators may assess the risks and benefits and to continue treatment with such medications under close observation for adverse events * patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects * patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 * female patient who is pregnant or breastfeeding * critical patient with a life expectancy \< 48 hours * patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation * patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock * patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening * patient has a mean corrected qt interval using fridericia's formula (qtcf) of \> 450 msec (for male patients) and \> 470 msec (for female patients) at screening * patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

March 3, 2022, 8:30 p.m. usa

non-hospitalized patients, including those requiring home oxygen support patient has a creatinine clearance < 50 ml/min/1.73m^2 using the modification of diet in renal disease formula patient cannot take the study drug by mouth and needs to be administered by nasogastric tube at screening. patient has a known allergy to any study medication or macrolides patient with known medical history of hepatitis b or, if tested, presence of hepatitis b surface antigen at screening patient has a known medical history of hepatitis c or positive hepatitis c antibody test result at screening (if obtained) patient has a positive hepatitis c rna test result at screening patient has a known medical history of human immunodeficiency virus (hiv) infection or was seropositive for human immunodeficiency virus (if tested) patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening patient has used a macrolide in the week prior to screening patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 patient receiving hemoperfusion or with anticipated use of hemoperfusion (including when hemoperfusion is a part of soc) patient has used the following types of medications < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period without an appropriate alternative therapy: narrow therapeutic index substrates of cytochrome p450 (cyp) enzymes narrow therapeutic index substrates of major transporters: organic anion transporting polypeptide 1b1 and 1b3 (oatp1b1, oatp1b3), organic anion transporter 1 and 3 (oat1, oat3), organic cation transporter 2 (oct2) and multidrug and toxin extrusion proteins 1 and 2-k (mate1, mate2k) strong inhibitors and/or inducers of enzymes cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, cyp3a4/5 strong inhibitors of transporters oatp1b1 and oatp1b3 note: strong inhibitors of oat1/oat3, oct2 and mate1/mate2k should be avoided when possible, but when unavoidable investigators may assess the risks and benefits and to continue treatment with such medications under close observation for adverse events patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 female patient who is pregnant or breastfeeding critical patient with a life expectancy < 48 hours patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

non-hospitalized patients, including those requiring home oxygen support patient has a creatinine clearance < 50 ml/min/1.73m^2 using the modification of diet in renal disease formula patient cannot take the study drug by mouth and needs to be administered by nasogastric tube at screening. patient has a known allergy to any study medication or macrolides patient with known medical history of hepatitis b or, if tested, presence of hepatitis b surface antigen at screening patient has a known medical history of hepatitis c or positive hepatitis c antibody test result at screening (if obtained) patient has a positive hepatitis c rna test result at screening patient has a known medical history of human immunodeficiency virus (hiv) infection or was seropositive for human immunodeficiency virus (if tested) patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening patient has used a macrolide in the week prior to screening patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 patient receiving hemoperfusion or with anticipated use of hemoperfusion (including when hemoperfusion is a part of soc) patient has used the following types of medications < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period without an appropriate alternative therapy: narrow therapeutic index substrates of cytochrome p450 (cyp) enzymes narrow therapeutic index substrates of major transporters: organic anion transporting polypeptide 1b1 and 1b3 (oatp1b1, oatp1b3), organic anion transporter 1 and 3 (oat1, oat3), organic cation transporter 2 (oct2) and multidrug and toxin extrusion proteins 1 and 2-k (mate1, mate2k) strong inhibitors and/or inducers of enzymes cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, cyp3a4/5 strong inhibitors of transporters oatp1b1 and oatp1b3 note: strong inhibitors of oat1/oat3, oct2 and mate1/mate2k should be avoided when possible, but when unavoidable investigators may assess the risks and benefits and to continue treatment with such medications under close observation for adverse events patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 female patient who is pregnant or breastfeeding critical patient with a life expectancy < 48 hours patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

May 27, 2021, 12:32 a.m. usa

- non-hospitalized patients, limitation of activities and/or requiring home oxygen support - patient has a creatinine clearance < 50 ml/min using the modification of diet in renal disease formula - patient has a known allergy to any study medication or macrolides - patient with the presence of hepatitis b surface antigen at screening - patient has a positive hepatitis c antibody test result at screening - patient has a positive hepatitis c rna test result at screening - patient was seropositive for human immunodeficiency virus - patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening - patient has used a macrolide in the week prior to screening - patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 - patient has used medications that are narrow therapeutic index cytochrome p450 (cyp) substrates or are strong inhibitors and/or inducers of cyp3a4 or cyp3a5 and organic anion transporting polypeptide (oatp)1b1 or oatp1b3 < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period - patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects - patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 - female patient who is pregnant or breastfeeding - critical patient with a life expectancy < 48 hours - patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation - patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock - patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening - patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening - patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

- non-hospitalized patients, limitation of activities and/or requiring home oxygen support - patient has a creatinine clearance < 50 ml/min using the modification of diet in renal disease formula - patient has a known allergy to any study medication or macrolides - patient with the presence of hepatitis b surface antigen at screening - patient has a positive hepatitis c antibody test result at screening - patient has a positive hepatitis c rna test result at screening - patient was seropositive for human immunodeficiency virus - patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to screening - patient has used a macrolide in the week prior to screening - patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 - patient has used medications that are narrow therapeutic index cytochrome p450 (cyp) substrates or are strong inhibitors and/or inducers of cyp3a4 or cyp3a5 and organic anion transporting polypeptide (oatp)1b1 or oatp1b3 < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period - patient has consumed foods and/or used herbal medicines with strong cyp3a4 or cyp3a5 effects - patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 - female patient who is pregnant or breastfeeding - critical patient with a life expectancy < 48 hours - patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation - patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock - patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening - patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening - patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

Dec. 19, 2020, 12:31 a.m. usa

- patient diagnosed with viral pneumonia other than covid-19 - non-hospitalized patients, limitation of activities and/or requiring home oxygen support - patient has a creatinine clearance < 50 ml/min using the modification of diet in renal disease formula - patient has a known allergy to any study medication or macrolides - patient with the presence of hepatitis b surface antigen at screening - patient has a positive hepatitis c antibody test result at screening - patient has a positive hepatitis c rna test result at screening - patient has positive immunodeficiency virus antibody test - patient has been treated with anti-tumor therapy in the past 30 days prior to screening - patient has used a macrolide in the week prior to screening - patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 - patient has used medications that are narrow therapeutic index cytochrome p450 (cyp) substrates or are strong inhibitors and/or inducers of cyp3a4 or cyp3a5 and organic anion transporting polypeptide (oatp)1b1 or oatp1b3 < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period - patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 - female patient who is pregnant or breastfeeding - critical patient with a life expectancy < 48 hours - patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation - patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock - patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening - patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening - patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator

- patient diagnosed with viral pneumonia other than covid-19 - non-hospitalized patients, limitation of activities and/or requiring home oxygen support - patient has a creatinine clearance < 50 ml/min using the modification of diet in renal disease formula - patient has a known allergy to any study medication or macrolides - patient with the presence of hepatitis b surface antigen at screening - patient has a positive hepatitis c antibody test result at screening - patient has a positive hepatitis c rna test result at screening - patient has positive immunodeficiency virus antibody test - patient has been treated with anti-tumor therapy in the past 30 days prior to screening - patient has used a macrolide in the week prior to screening - patient has used antiviral drugs which are not part of soc < 24 hours prior to day 1 - patient has used medications that are narrow therapeutic index cytochrome p450 (cyp) substrates or are strong inhibitors and/or inducers of cyp3a4 or cyp3a5 and organic anion transporting polypeptide (oatp)1b1 or oatp1b3 < 2 days prior to day 1 and/or plans to initiate such medications during the treatment period - patient who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through day 60 - female patient who is pregnant or breastfeeding - critical patient with a life expectancy < 48 hours - patient who has received an organ transplant in the past 6 months prior to screening or is on the waiting list for organ transplantation - patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock - patient requiring mechanical ventilation or extracorporeal membrane oxygenation at screening - patient has a mean corrected qt interval using fridericia's formula (qtcf) of > 450 msec (for male patients) and > 470 msec (for female patients) at screening - patient who has a history of alcohol abuse within 3 months prior to the study as judged by the investigator