Correlated Drug Terms (3)

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	Name (Synonyms)	Correlation
drug730	Sampling salivary Wiki	1.00
drug396	Hydroxychloroquine sulfate Wiki	0.71
drug478	Lopinavir/ritonavir Wiki	0.32

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D018352	Coronavirus Infections NIH	0.06

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Clinical status of subject at day 15 (on a 7 point ordinal scale).

Time: Up to 15 days

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Secondary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.

Time: Up to 180 days

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Description: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.

Measure: Length of time to clinical improvement

Time: Up to 29 days

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Measure: Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29

Time: Up to 29 days

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Measure: Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment

Time: Up to 24 weeks

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Description: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission

Measure: Length of time to clinical progression

Time: Up to 29 days

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Measure: Cause of death (if applicable)

Time: Up to 24 weeks

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Measure: Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)

Time: Up to 29 days

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Description: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours

Measure: Length of time to normalization of fever

Time: Up to 29 days

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Description: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.

Measure: Length of time to normalization of oxygen saturation

Time: Up to 29 days

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Measure: Duration of supplemental oxygen (if applicable)

Time: Up to 29 days

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Measure: Duration of mechanical ventilation (if applicable)

Time: Up to 29 days

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Measure: Duration of hospitalization

Time: Up to 29 days

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Measure: Adverse events

Time: Up to 180 days

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Other Outcomes

Measure: Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm

Time: Up to 180 days

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Measure: Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180.

Time: Up to 180 days

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Measure: Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180.

Time: Up to 180 days

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