Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug2316	Standard care therapy Wiki	1.00

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D007239	Infection NIH	0.06

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.

Measure: Proportion of patients developing severe ARDS.

Time: 28 days

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Secondary Outcomes

Measure: All-cause mortality.

Time: 28 days

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Measure: Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period

Time: 28 days

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Measure: Percentage of patients who progress to severe ARDS, death or ICU admission.

Time: 28 days

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Description: Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2. Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment. Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours). SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).

Measure: Differences in Time to Clinical Improvement

Time: 28 days

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Description: The ordinal scale of 7 categories of patient health status ranges from: Death. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Non-hospitalized, activity limitation. Non-hospitalized, no activity limitation.

Measure: Change in clinical status of subject on a 7-point ordinal scale.

Time: 28 days

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Measure: Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication.

Time: 28 days

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Description: Classification according to the WHO toxicity scale

Measure: Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment.

Time: 28 days

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