Created at Source Raw Value Validated value
Nov. 6, 2020, 11:45 p.m. oms

1. Adults &#8805,18 years of age. 2. Known diagnosis of active cancer that is not considered cured or disease free. 3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen 4. Adequate hematological function independent of growth factor support for at least 7 days except for pegylated G-CSF and darbepoetin which require at least 14 days, defined as: a. Absolute neutrophil count (ANC) &#8805, 1.0 × 109 /L for subjects with solid malignancies. ANC &#8805, 0.75 × 109 /L for subjects with hematologic malignancies b. Platelet count &#8805, 75 × 109 /L for subjects with solid malignancies. Platelet count &#8805, 50 × 109 /L for subjects with hematologic malignancies. 5. Adequate hepatic function defined by: a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin &#8804,2.0 × ULN b. Aspartate aminotransferase (AST) &#8804, 2.5 × ULN, and alanine aminotransferase (ALT) &#8804, 2.5 × ULN. 6. Adequate renal function defined by an estimated creatinine clearance &#8805, 30 mL/min according Cockcroft Gault method. 7. Ability to swallow and absorb oral medications 8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug. Effective birth control for males is the use of condoms. Effective birth control for females includes (a) combined, estrogen- and progestogen-containing hormonal contraception (oral, intravaginal, transdermal), (b) intrauterine device combined with a barrier method, (c) intrauterine hormone-releasing system combined with a barrier method, (d) bilateral tubal occlusion/ligation, (e) vasectomized partner, (f) sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

1. Adults &#8805,18 years of age. 2. Known diagnosis of active cancer that is not considered cured or disease free. 3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen 4. Adequate hematological function independent of growth factor support for at least 7 days except for pegylated G-CSF and darbepoetin which require at least 14 days, defined as: a. Absolute neutrophil count (ANC) &#8805, 1.0 × 109 /L for subjects with solid malignancies. ANC &#8805, 0.75 × 109 /L for subjects with hematologic malignancies b. Platelet count &#8805, 75 × 109 /L for subjects with solid malignancies. Platelet count &#8805, 50 × 109 /L for subjects with hematologic malignancies. 5. Adequate hepatic function defined by: a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin &#8804,2.0 × ULN b. Aspartate aminotransferase (AST) &#8804, 2.5 × ULN, and alanine aminotransferase (ALT) &#8804, 2.5 × ULN. 6. Adequate renal function defined by an estimated creatinine clearance &#8805, 30 mL/min according Cockcroft Gault method. 7. Ability to swallow and absorb oral medications 8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug. Effective birth control for males is the use of condoms. Effective birth control for females includes (a) combined, estrogen- and progestogen-containing hormonal contraception (oral, intravaginal, transdermal), (b) intrauterine device combined with a barrier method, (c) intrauterine hormone-releasing system combined with a barrier method, (d) bilateral tubal occlusion/ligation, (e) vasectomized partner, (f) sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.