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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001953-36 | EudraCT Number |
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The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolastin 120 mg/kg + Standard Medical Treatment | Experimental | Subjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
|
| Standard Medical Treatment | Active Comparator | Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolastin | Biological | Intravenous infusion 120 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Dying or Requiring ICU Admission | Up to Day 15 | |
| Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in National Early Warning Score (NEWS) | Day 1 through Day 29 | |
| Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours | Day 1 through Day 29 | |
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Inclusion Criteria:
Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission.
Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR) or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
COVID-19 illness (symptoms) of any duration, including both of the following:
Subjects provides informed consent prior to the initiation of any study procedures.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Burgos | Burgos | Castille and León | 09006 | Spain | ||
| Hospital Universitari Germans Trias i Pujol |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000515 | alpha 1-Antitrypsin |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D015843 | Serpins |
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| Standard Medical Treatment | Drug | Standard medical treatment per local policies or guidelines |
|
|
| Time to Hospital Discharge |
| Day 1 through Day 29 |
| Duration of ICU Stay | Up to Day 29 |
| Duration of Any Oxygen Use | Day 1 through Day 29 |
| Duration of Mechanical Ventilation | Up to Day 29 |
| Mean Change from Baseline in Ordinal Scale | Day 1 through Day 29 |
| Absolute Value Change from Baseline in Ordinal Scale | Day 1 through Day 29 |
| Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale | Day 15, Day 29 |
| Time to Sustained Normalization of Temperature | Day 1 through Day 29 |
| Percentage of Subjects who Sustained Normalization of Temperature | Day 1 through Day 29 |
| Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS) | Up to Day 29 |
| Length of Time to Clinical Progression | Up to Day 29 |
| Mortality Through Day 29 | Up to Day 29 |
| Badalona |
| Spain |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital Universitario Valle de Hebrón | Barcelona | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital General Gregorio Marañón | Madrid | Spain |
| Hospital Universitario Infanta Leonor | Madrid | Spain |
| Hospital Universitario Príncipe de Asturias | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000510 | Alpha-Globulins |
| D012712 | Serum Globulins |
| D005916 | Globulins |