Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrolment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status \< or = 3 (appendix i). 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: * patients with a new cancer diagnosis who have not yet initiated cancer therapy. * patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). 8. covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). 9. estimated life expectancy of at least 6 months at hospital admission for covid-19. 10. patients must be receiving standard of care for sars-cov-2. 11. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: * hemoglobin ≥ 9.0 g / dl. * leukometry\> 2,000 / mm3 (\> 2 10e3/ ul). * absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). * platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). * creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. * total bilirubin \<3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. * aspartate aminotransaminase (ast) \<3.0 x lsn. * alanine aminotransaminase (alt) \<3.0 x uln.

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrolment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status \< or = 3 (appendix i). 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: * patients with a new cancer diagnosis who have not yet initiated cancer therapy. * patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). 8. covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). 9. estimated life expectancy of at least 6 months at hospital admission for covid-19. 10. patients must be receiving standard of care for sars-cov-2. 11. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: * hemoglobin ≥ 9.0 g / dl. * leukometry\> 2,000 / mm3 (\> 2 10e3/ ul). * absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). * platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). * creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. * total bilirubin \<3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. * aspartate aminotransaminase (ast) \<3.0 x lsn. * alanine aminotransaminase (alt) \<3.0 x uln.

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

inclusion criteria: documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. male or female ≥18 years of age at time of enrolment. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). eastern cooperative oncology group (ecog) status < or = 3 (appendix i). patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: patients with a new cancer diagnosis who have not yet initiated cancer therapy. patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). estimated life expectancy of at least 6 months at hospital admission for covid-19. patients must be receiving standard of care for sars-cov-2. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: hemoglobin ≥ 9.0 g / dl. leukometry> 2,000 / mm3 (> 2 10e3/ ul). absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. aspartate aminotransaminase (ast) <3.0 x lsn. alanine aminotransaminase (alt) <3.0 x uln.

inclusion criteria: documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. male or female ≥18 years of age at time of enrolment. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). eastern cooperative oncology group (ecog) status < or = 3 (appendix i). patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: patients with a new cancer diagnosis who have not yet initiated cancer therapy. patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). estimated life expectancy of at least 6 months at hospital admission for covid-19. patients must be receiving standard of care for sars-cov-2. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: hemoglobin ≥ 9.0 g / dl. leukometry> 2,000 / mm3 (> 2 10e3/ ul). absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. aspartate aminotransaminase (ast) <3.0 x lsn. alanine aminotransaminase (alt) <3.0 x uln.

July 8, 2021, 4 a.m. usa

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrolment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status < or = 3 (appendix i). 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: - patients with a new cancer diagnosis who have not yet initiated cancer therapy. - patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). 8. covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). 9. estimated life expectancy of at least 6 months at hospital admission for covid-19. 10. patients must be receiving standard of care for sars-cov-2. 11. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: - hemoglobin ≥ 9.0 g / dl. - leukometry> 2,000 / mm3 (> 2 10e3/ ul). - absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). - platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). - creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. - total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. - aspartate aminotransaminase (ast) <3.0 x lsn. - alanine aminotransaminase (alt) <3.0 x uln.

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrolment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status < or = 3 (appendix i). 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: - patients with a new cancer diagnosis who have not yet initiated cancer therapy. - patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 4 ("hospitalized; no oxygen therapy "), = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow ") (appendix ii). 8. covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan). 9. estimated life expectancy of at least 6 months at hospital admission for covid-19. 10. patients must be receiving standard of care for sars-cov-2. 11. patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by: - hemoglobin ≥ 9.0 g / dl. - leukometry> 2,000 / mm3 (> 2 10e3/ ul). - absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10e3/ul). - platelet count ≥ 100,000 / mm3 (≥100 10e3/ul). - creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. - total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. - aspartate aminotransaminase (ast) <3.0 x lsn. - alanine aminotransaminase (alt) <3.0 x uln.

Jan. 30, 2021, 12:31 a.m. usa

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrollment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status < or = 3. 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: - patients with a new cancer diagnosis who have not yet initiated cancer therapy. - patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow "). 8. estimated life expectancy of at least 6 months at hospital admission for covid-19. 9. patients must be receiving standard of care for sars-cov-2. 10. patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by: - hemoglobin ≥ 9.0 g / dl - leukometry> 2,000 / mm3 - absolute neutrophil count ≥ 1,500 / mm3 - platelet count ≥ 100,000 / mm3 - creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. - total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. - aspartate aminotransaminase (ast) <3.0 x lsn. - alanine aminotransaminase (alt) <3.0 x uln. 11. patient should have not received a prior systemic antiviral treatment for covid-19 disease.

inclusion criteria: 1. documented informed consent of the patient and/or legally authorized representative. assent, when appropriate, will be obtained per institutional guidelines. 2. male or female ≥18 years of age at time of enrollment. 3. history of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization). 4. eastern cooperative oncology group (ecog) status < or = 3. 5. patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. this includes: - patients with a new cancer diagnosis who have not yet initiated cancer therapy. - patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study. 6. currently hospitalized with laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) collected within one week prior to randomization. 7. initial covid-19 severity status on the who 11-point ordinal scale for clinical improvement = 5 ("hospitalized; oxygen by mask or nasal prongs "), or 6 ("hospitalized; oxygen by niv or high flow "). 8. estimated life expectancy of at least 6 months at hospital admission for covid-19. 9. patients must be receiving standard of care for sars-cov-2. 10. patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by: - hemoglobin ≥ 9.0 g / dl - leukometry> 2,000 / mm3 - absolute neutrophil count ≥ 1,500 / mm3 - platelet count ≥ 100,000 / mm3 - creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. - total bilirubin <3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. - aspartate aminotransaminase (ast) <3.0 x lsn. - alanine aminotransaminase (alt) <3.0 x uln. 11. patient should have not received a prior systemic antiviral treatment for covid-19 disease.