Correlated Drug Terms (4)

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	Name (Synonyms)	Correlation
drug2137	SARS-CoV-2 non-immune Plasma Wiki	1.00
drug2265	Single Dose of Hydroxychloroquine Wiki	0.71
drug1219	Interferon Beta-1A Wiki	0.50
drug1355	Lopinavir / Ritonavir Wiki	0.50

Correlated MeSH Terms (2)

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	Name (Synonyms)	Correlation
D003289	Convalescence NIH	0.45
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.

Measure: Efficacy of treatment at Day 28

Time: Day 28

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Description: Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1

Time: Up to Day 28

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Description: Cumulative incidence of grade 3 and 4 adverse events during the study period

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2

Time: Up to Day 28

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Secondary Outcomes

Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection

Measure: Cumulative incidence of disease severity

Time: up to Day 28

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Other Outcomes

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).

Measure: Anti-SARS-CoV-2 titers Day 0

Time: Day 0

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Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.

Measure: Anti-SARS-CoV-2 titers Day 1

Time: Day 1

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Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.

Measure: Anti-SARS-CoV-2 titers Day 7

Time: Day 7

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Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.

Measure: Anti-SARS-CoV-2 titers Day 14

Time: Day 14

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Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.

Measure: Anti-SARS-CoV-2 titers Day 90

Time: Day 90

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Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Rates of SARS-CoV-2 PCR positivity

Time: Up to day 28

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Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Duration of SARS-CoV-2 PCR positivity

Time: Up to day 28

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Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.

Measure: Peak quantity levels of SARS-CoV-2 RNA

Time: Up to day 28

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