Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (0)

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	Name (Synonyms)	Correlation

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

Measure: Mean change in oxygenation

Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

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Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

Measure: Median change in oxygenation

Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

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Secondary Outcomes

Measure: number of AE's (Adverse Events)

Time: during hospital admission (up to 28 days)

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Measure: number of SAE's (Serious Adverse Events)

Time: during hospital admission (up to 28 days)]

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Description: 6-point ordinal scale defined as Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: mean change in 6-point ordinal scale change

Time: between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call).

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Description: defined as independence from supplemental oxygen

Measure: Time since randomization until improvement in oxygenation

Time: during hospital admission (up to 28 days)

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Description: defined as SpO2 < 93% breathing room air or the dependence on supplemental oxygen

Measure: Number of days with hypoxia

Time: during hospital admission (up to 28 days)

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Measure: Number of days of supplemental oxygen use

Time: during hospital admission (up to 28 days)

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Measure: Time to absence of fever (defined as 37.1°C or more) for more than 48h without antipyretic

Time: during hospital admission (up to 28 days)

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Description: defined as 37.1°C or more

Measure: Number of days with fever

Time: during hospital admission (up to 28 days)

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Measure: Mean change in CRP levels between day 1 and day 6

Time: day 1, day 6

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Measure: Mean change in CRP levels between day 1 and day 15 (or discharge whichever comes first)

Time: day 1, day 15

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Measure: Mean change in ferritin levels between day 1 and day 6

Time: day 1, day 6

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Measure: Mean change in ferritin levels between day 1 and day 15 (or discharge, whichever comes first)

Time: day 1, day 15

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Measure: Incidence of AE's

Time: during hospital admission (up to 28 days)

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Measure: Incidence of SAE's

Time: at 10-20 weeks follow-up

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Measure: Incidence of SUSAR's (Suspected Unexpected Serious Adverse Reaction)

Time: during hospital admission (up to 28 days)

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Measure: Incidence of SAR's (Serious Adverse Reaction)

Time: during hospital admission (up to 28 days)

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Measure: Duration of hospital stay

Time: during hospital admission (up to 28 days)

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Measure: Duration of hospital stay in survivors

Time: during hospital admission (up to 28 days)

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Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score between day 1 and day 6 (or on discharge, whichever is first)

Time: day 1, day 6 or on discharge, whichever is first

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Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score between day 1 and day 15 or on discharge, whichever is first)

Time: day 1, day 15 or on discharge, whichever is first

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Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale at randomization, day 6 and 15 (or discharge, whichever comes first) and day 28 (phone call)

Time: day 1, day 6, day 15 (or discharge, whichever comes first)

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Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: 6-point Ordinal Scale at 6 and 15 days (or discharge whichever comes first) and day 28 (phone call), in relation to serum D-dimers and complement C5a levels at randomization

Time: day 1, day 6, day 15 (or discharge, whichever comes first)

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Measure: Incidence of nosocomial bacterial or invasive fungal infection for 28 days (phone call) after enrolment in trial

Time: day 28

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Measure: Time since randomization until first use of high-flow oxygen devices in non-ventilated patients

Time: during hospital admission (up to 28 days)

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Measure: Time since randomization until first use of non-invasive mechanical ventilation in non-ventilated patients

Time: during hospital admission (up to 28 days)

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Measure: Time since randomization until first use of invasive mechanical ventilation in non-ventilated patients

Time: during hospital admission (up to 28 days)

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Measure: Number of ventilator-free days

Time: day 1, day 28 or discharge whichever comes first

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Measure: Duration of invasive and non-invasive mechanical ventilation in ventilated patients

Time: during hospital admission (up to 28 days)

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Measure: Duration of ICU stay in patients that enrolled in trial on invasive or non-invasive mechanical ventilation for less than 24h prior to or after randomization

Time: during hospital admission (up to 28 days)

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Description: criteria-defined ARDS criteria-defined ARDS according to the adapted Berlin criteria as follow: within 1 week of a known Clinical insult or new or worsening respiratory symptoms bilateral infiltrates not supposed to be of cardiac origin or fluid overload PaO2/FiO2 < 300 mmHg

Measure: Time since randomization to progression to ARDS (Acute Respiratory Distress Syndrome)

Time: during hospital admission (up to 28 days)

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Measure: Time to progression to ARDS in ventilated patients according to D-dimers at randomization

Time: during hospital admission (up to 28 days)

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Measure: Time to progression to ARDS in ventilated patients according to complement C5a at randomization

Time: during hospital admission (up to 28 days)

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Measure: All-cause mortality rate (excluding group that entered during ventilation)

Time: at day 28

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Measure: All-cause mortality rate (including group that entered during ventilation)

Time: at day 28

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Measure: Percentage of patients in clinical status on 6-point Ordinal Scale

Time: at 12-22 weeks follow-up

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Measure: Incidence of lung function abnormalities at follow up

Time: at 12-22 weeks follow-up

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Measure: Incidence of lung fibrosis on chest CT scan at follow up

Time: at 12-22 weeks follow-up

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Measure: All cause mortality for the entire study population

Time: at follow up 12-22 weeks

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