Table 2.

Study outcomes

Primary endpoints (Up to day 15 of follow-up after randomization)
Occurrence of clinical worsening defined as any of the following: a. Moderate or severe dyspnoea b. Drop in O2 saturation (<92% with patient exposure to room air) and/or additional oxygen demand to maintain O2 saturation ≥ 92%) and/or c. Achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale) Meeting the above criteria qualifies the patient for further treatment in hospital, in accordance with the current recommendations
Secondary endpoints (Day 15 or optionally on Day 30 in double blind phase) and 90, 150, 210 (in open label phase) from randomization)
a. General Health Assessment (PROMIS Global Health Scale) b. The neurological assessment will include the assessment of neurological functions based on scales for: - fatigue (Fatigue Severity Scale) - depression (Beck Depression Inventory (BDI)), - disorders of smell and taste (Visual Analogue Scale (VAS)), - sleep disorders (The Epworth Sleepiness Scale (ESS)) - quality of life (The Short Form-36 Health Survey Questionnaire (SF-36)) c. Time to clinical deterioration d. Time of Survival