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May 4, 2021, 2:30 a.m. eu

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen ≤72h prior to randomization. 2. Hospitalized patients for the treatment of COVID pneumopathy 3. Patients not requiring invasive intubation at admission with moderate and severe pneumopathy according to the 7-point ordinal scale i.e. 1. Not hospitalized, no limitations on activities, 2.Not hospitalized, limitation on activities, 3. Hospitalized, not requiring supplemental oxygen, 4. Hospitalized, requiring supplemental oxygen, 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6. Hospitalized, on invasive mechanical ventilation or ECMO, 7. Death. Moderate cases (3, and 4 , 7-point ordinal scale) i.e. cases meeting all of the following criteria: Showing fever and respiratory symptoms with radiological findings of pneumonia. Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases (score 5, 7-point ordinal scale) i.e. cases meeting any of the following criteria: Respiratory distress (≧30 breaths/ min), Oxygen saturation≤93% at rest in ambient air, or Oxygen saturation ≤97 % with O2 > 5L/min. PaO2/FiO2≦300mmHg 4. Male or non-pregnant female adult ≥ 18 years of age at time of enrolment. 5. Patient with body weight > 45 kg and body mass index (BMI) ≥ 18 and ≤35 kg/m2. 6. Patient must be able and willing to comply with study visits and procedures. 7. Patient agrees to the collection of nasopharyngeal swabs and venous blood per protocol 8. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures. 9. Contraception: - Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 6 months after the last treatment intake - Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 3 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake Highly effective and effective methods of contraception are detailed in appendix 19.3 of the protocol.

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen ≤72h prior to randomization. 2. Hospitalized patients for the treatment of COVID pneumopathy 3. Patients not requiring invasive intubation at admission with moderate and severe pneumopathy according to the 7-point ordinal scale i.e. 1. Not hospitalized, no limitations on activities, 2.Not hospitalized, limitation on activities, 3. Hospitalized, not requiring supplemental oxygen, 4. Hospitalized, requiring supplemental oxygen, 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6. Hospitalized, on invasive mechanical ventilation or ECMO, 7. Death. Moderate cases (3, and 4 , 7-point ordinal scale) i.e. cases meeting all of the following criteria: Showing fever and respiratory symptoms with radiological findings of pneumonia. Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases (score 5, 7-point ordinal scale) i.e. cases meeting any of the following criteria: Respiratory distress (≧30 breaths/ min), Oxygen saturation≤93% at rest in ambient air, or Oxygen saturation ≤97 % with O2 > 5L/min. PaO2/FiO2≦300mmHg 4. Male or non-pregnant female adult ≥ 18 years of age at time of enrolment. 5. Patient with body weight > 45 kg and body mass index (BMI) ≥ 18 and ≤35 kg/m2. 6. Patient must be able and willing to comply with study visits and procedures. 7. Patient agrees to the collection of nasopharyngeal swabs and venous blood per protocol 8. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures. 9. Contraception: - Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 6 months after the last treatment intake - Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 3 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake Highly effective and effective methods of contraception are detailed in appendix 19.3 of the protocol.

Oct. 26, 2020, 7:26 a.m. eu

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization. 2. Hospitalized patients 3. Patients not requiring ICU at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy. Moderate cases i.e. cases meeting all of the following criteria: Showing fever and respiratory symptoms with radiological findings of pneumonia. Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases i.e. cases meeting any of the following criteria: Respiratory distress (≧30 breaths/ min), Oxygen saturation≤93% at rest in ambient air, or Oxygen saturation ≤97 % with O2 > 5L/min. PaO2/FiO2≦300mmHg 4. Male or non-pregnant female adult ≥ 18 and < 80 years of age at time of enrolment. 5. Patient with body weight > 45 kg and body mass index (BMI) between 18 and 35 kg/m2 (inclusive). 6. Patient must be able and willing to comply with study visits and procedures. 7. Patient agrees to the collection of oropharyngeal swabs and venous blood per protocol 8. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures. 9. Patient able to understand the patient card and follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity.

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization. 2. Hospitalized patients 3. Patients not requiring ICU at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy. Moderate cases i.e. cases meeting all of the following criteria: Showing fever and respiratory symptoms with radiological findings of pneumonia. Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases i.e. cases meeting any of the following criteria: Respiratory distress (≧30 breaths/ min), Oxygen saturation≤93% at rest in ambient air, or Oxygen saturation ≤97 % with O2 > 5L/min. PaO2/FiO2≦300mmHg 4. Male or non-pregnant female adult ≥ 18 and < 80 years of age at time of enrolment. 5. Patient with body weight > 45 kg and body mass index (BMI) between 18 and 35 kg/m2 (inclusive). 6. Patient must be able and willing to comply with study visits and procedures. 7. Patient agrees to the collection of oropharyngeal swabs and venous blood per protocol 8. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures. 9. Patient able to understand the patient card and follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity.