Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug2122	Placebo Wiki	0.05

Correlated MeSH Terms (5)

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	Name (Synonyms)	Correlation
D013577	Syndrome NIH	0.10
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.09
D012128	Respiratory Distress Syndrome, Adult NIH	0.08
D011014	Pneumonia NIH	0.06

Correlated HPO Terms (1)

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	Name (Synonyms)	Correlation
HP:0002090	Pneumonia HPO	0.06

Primary Outcomes

Description: The primary endpoint is the proportion of patients with clinical improvement at 28 days after treatment. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale. Scale categories as follows: 1 = not hospitalized; 2 = not hospitalized with limitation of activities and/or oxygen requirement; 3 = hospitalized not requiring supplemental oxygen and not requiring active medical care, 4 = hospitalized requiring active medical care without requiring oxygen supplementation; 5 = hospitalized requiring oxygen supplementation; 6 = hospitalized requiring high-flow oxygen or non-invasive mechanical ventilation; 7 = hospitalized requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8 = death.

Measure: Proportion of patients with improvement in clinical status

Time: 28 days

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Secondary Outcomes

Description: Time from the day of treatment until the first day with clinical improvement, defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale.

Measure: Time to clinical improvement

Time: 28 days

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Description: Proportion of participant death or non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation requirement.

Measure: Proportion of patients that reach a score of 6, 7 or 8 in the NIAID 8-point ordinal scale

Time: 28 days

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Description: Measured in days

Measure: Duration of hospitalization

Time: 28 days

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Description: Proportion of patients that have a negative polymerase chain reaction assay for SARS-CoV-2 at 72 hrs from start of treatment.

Measure: SARS-CoV-2 PCR negativization rate

Time: 3 days

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Description: Proportion of patients with clinical improvement at day 7. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale

Measure: Proportion of patients with clinical improvement at day 7

Time: 7 days

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Description: Proportion of patients that present within 24 hours of treatment with immediate adverse events defined as: skin rash and/or respiratory findings (dyspnea, wheezing, bronchospasm, hypoxia) and/or circulatory compromise (reduction of blood pressure or associated symptoms, i.e. syncope).

Measure: Proportion of patients with immediate adverse events (< 24 hours)

Time: 24 hours

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Description: Proportion of patients that present events associated with serum sickness (type 3 hypersensitivity), vasculitis, glomerulonephritis, arthritis.

Measure: Proportion of patients with late adverse events (1 - 28 days)

Time: 28 days

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