Created at Source Raw Value Validated value
Oct. 14, 2021, 1:55 p.m. eu

1. Age 18 or older at the time of enrolment. 2. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) which is preferable. However if limited access to the test, symptoms of COVID-19 associated with “lung imaging findings” on chest CT scan: unilateral or bilateral ground-glass opacities and/or consolidation. 3. Clinical status: News2 score from 5 to 6. 4. 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), 5. Willingness and ability to comply with the study requirements, 6. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment, 7. Women of childbearing potential 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, 8. Women of childbearing potential and male patients must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy,

1. Age 18 or older at the time of enrolment. 2. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) which is preferable. However if limited access to the test, symptoms of COVID-19 associated with “lung imaging findings” on chest CT scan: unilateral or bilateral ground-glass opacities and/or consolidation. 3. Clinical status: News2 score from 5 to 6. 4. 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), 5. Willingness and ability to comply with the study requirements, 6. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment, 7. Women of childbearing potential 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, 8. Women of childbearing potential and male patients must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy,