This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial.
Patients will be randomized into two arms of treatment:
Placebo + SoC (N=30)
NanoManganese® + SoC (N=90)
Patients will be treated and followed-up for 10 days:
Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10,
Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily,
Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10,
Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10,
Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following.
assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.