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

inclusion criteria: i1. age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). note: item cancelled (addendum 2 - october 2020) i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: * bone marrow: * hemoglobin ≥ 9.0 g/dl, * absolute neutrophils count (anc) ≥ 1.0 gi/l, * platelets ≥ 100 gi/l; * hepatic function: * total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), * ast/alt ≤ 5 uln * renal function: * serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 1) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.

inclusion criteria: i1. age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). note: item cancelled (addendum 2 - october 2020) i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: * bone marrow: * hemoglobin ≥ 9.0 g/dl, * absolute neutrophils count (anc) ≥ 1.0 gi/l, * platelets ≥ 100 gi/l; * hepatic function: * total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), * ast/alt ≤ 5 uln * renal function: * serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 1) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.

Dec. 7, 2020, 12:31 a.m. usa

inclusion criteria: i1. age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). note: item cancelled (addendum 2 - october 2020) i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: - bone marrow: - hemoglobin ≥ 9.0 g/dl, - absolute neutrophils count (anc) ≥ 1.0 gi/l, - platelets ≥ 100 gi/l; - hepatic function: - total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), - ast/alt ≤ 5 uln - renal function: - serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 1) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.

inclusion criteria: i1. age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). note: item cancelled (addendum 2 - october 2020) i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: - bone marrow: - hemoglobin ≥ 9.0 g/dl, - absolute neutrophils count (anc) ≥ 1.0 gi/l, - platelets ≥ 100 gi/l; - hepatic function: - total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), - ast/alt ≤ 5 uln - renal function: - serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 1) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: i1. age 18 or older at the time of enrolment. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) or symptoms of covid-19 associated with radiological signs of pneumonia as described by shi et al.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: - bone marrow: - hemoglobin ≥ 7.0 g/dl, - absolute neutrophils count (anc) ≥ 1.0 gi/l, - platelets ≥ 100 gi/l; - hepatic function: - total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), - ast and alt ≤ 5 uln - renal function: - serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 2) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 2) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.

inclusion criteria: i1. age 18 or older at the time of enrolment. i2. histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). i3. documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory) or symptoms of covid-19 associated with radiological signs of pneumonia as described by shi et al.; nota bene : a maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). in cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. i4. cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2) (pao2:fio2) at or below 300 mg hg. i5. multidisciplinary approach that patient is not eligible for a transfer to resuscitation unit (either due to underlying medical condition - including cancer - or due to lack of available bed). i6. life-expectancy longer than 3 months. i7. adequate bone marrow and end-organ function defined by the following laboratory results: - bone marrow: - hemoglobin ≥ 7.0 g/dl, - absolute neutrophils count (anc) ≥ 1.0 gi/l, - platelets ≥ 100 gi/l; - hepatic function: - total serum bilirubin ≤ 1.5 x uln (except patients with gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x uln), - ast and alt ≤ 5 uln - renal function: - serum creatinine ≤ 2.0 x uln or cr. cl. ≥ 30ml/min/1.73m² (mdrd or ckd-epi formula); i8. willingness and ability to comply with the study requirements; i9. signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 patient information and informed consent); i10. women of childbearing potential (appendix 2) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. a positive urine test must be confirmed by a serum pregnancy test; i11. women of childbearing potential and male patients must agree to use adequate highly effective contraception (appendix 2) for the duration of study participation and up to 6 months following completion of therapy; i12. patient must be covered by a medical insurance.