Created at Source Raw Value Validated value
Nov. 6, 2020, 11:45 p.m. oms

From the Master study : 1. Male or female patients, 2. Adults over or equal to 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening. 4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) over or equal to 94%. 5. Corrected QT interval (QTc – Bazett and Fridericia) < 480 msec on ECG. 6. Signed written consent from the patient or his/her representative. 7. Accepting and having the ability to be reached by telephone throughout the study. 8. Having designated a contact person who can be contacted in case of emergency. For the Immuno Ancillary study 1. Able and willing to provide consent for the immunological ancillary study 2. Able and willing to perform all study visits for a duration of 12 months after treatment start

From the Master study : 1. Male or female patients, 2. Adults over or equal to 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening. 4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) over or equal to 94%. 5. Corrected QT interval (QTc – Bazett and Fridericia) < 480 msec on ECG. 6. Signed written consent from the patient or his/her representative. 7. Accepting and having the ability to be reached by telephone throughout the study. 8. Having designated a contact person who can be contacted in case of emergency. For the Immuno Ancillary study 1. Able and willing to provide consent for the immunological ancillary study 2. Able and willing to perform all study visits for a duration of 12 months after treatment start