Created at Source Raw Value Validated value
May 2, 2022, 3:30 p.m. eu

To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria: 1. Informed consent signed 2. Male and female ≥18 years old, 3. Patients hospitalized for SARS-CoV-2 infection RT-PCR-confirmed in the previous 10 days, 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6), 5. Radiological infiltrates by chest imaging, 6. SpO2 <94% at room air, or PaO2/FiO2 <300, 7. At least one inflammatory marker above ULN (LDH, CRP, ferritin, D-dimer), 8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: a. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake

To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria: 1. Informed consent signed 2. Male and female ≥18 years old, 3. Patients hospitalized for SARS-CoV-2 infection RT-PCR-confirmed in the previous 10 days, 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6), 5. Radiological infiltrates by chest imaging, 6. SpO2 <94% at room air, or PaO2/FiO2 <300, 7. At least one inflammatory marker above ULN (LDH, CRP, ferritin, D-dimer), 8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: a. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake