Table 3.

Collected data during trial

	All patients
Baseline data	Baseline data Demographics: age, gender, place of residence Comorbidities: diabetes mellitus, arterial hypertension, congestive heart failure, chronic obstructive airways disease, chronic liver disease, malignancy, chronic renal failure Preadmission medication Functional status/frailty score
	Non-ventilated patients	Ventilated patients
Daily observations	Daily saturations (worst values) Daily oxygen flow Fluid input Urine output Fluid balance	Daily PaO2/FiO2 ratio Daily oxygen flow Fluid input Urine output Fluid balance Vasopressor data
Laboratory investigations (collected at 0800)	Daily serum creatinine Daily liver function Daily blood count Daily zinc and trace metal concentration (copper, potassium, magnesium) Daily cardiac troponin Daily lactate level	Daily serum creatinine Daily liver function Daily blood count Daily zinc and trace metal concentration (copper, potassium and magnesium) Daily cardiac troponin Daily lactate level
Primary outcome measures	Mean change in highest level of oxygenation requirement (oxygen flow in litres/min)	Mean change in lowest PaO2/FiO2 ratio (in mm Hg)
Secondary outcome measures	Mortality (time frame: up to day 28) Duration of oxygen therapy (days) Duration of hospitalisation (days) Length of stay in the intensive care unit (ICU) and hospital Frequency of serious adverse drug events Acute kidney injury Acute liver injury Time to resolution of fever for at least 48 hours without antipyretics by clinical severity Incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection Number of patients admitted into an ICU (time frame: up to day 28) Sequential organ failure assessment (SOFA) respiratory score (time frame: 28 days). Assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) Clinical improvement based on an eight-point ordinal scale recommended in the document published by WHO R&D Blueprint ‘Novel Coronavirus COVID-19 Therapeutic Trial Synopsis’. Percentage of patients reporting each severity rating on an eight-point ordinal scale (time frame: day 14) Time to improvement in one category from admission using the eight-point ordinal scale (time frame: up to day 28) Mean change in the eight-point ordinal scale (time frame: up to day 28)	Mortality (time frame: up to day 28) Duration of mechanical ventilation (days) Duration of oxygen therapy (days) Duration of hospitalisation (days) Length of stay in the ICU and hospital Frequency of serious adverse drug events Acute kidney injury Acute liver injury Use, duration and dosage of vasopressor drugs Time to resolution of fever for at least 48 hours without antipyretics by clinical severity Incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection Number of patients admitted into an ICU (time frame: up to day 28) SOFA respiratory score (time frame: 28 days). Assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) Clinical improvement based on an eight-point ordinal scale recommended in the document published by WHO R&D Blueprint ‘Novel Coronavirus COVID-19 Therapeutic Trial Synopsis’. Percentage of patients reporting each severity rating on an eight-point ordinal scale (time frame: day 14) Time to improvement in one category from admission using the eight-point ordinal scale (time frame: up to day 28) Mean change in the eight-point ordinal scale (time frame: up to day 28)