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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001696-32 | EudraCT Number |
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The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Immune Globulin + Standard Medical Treatment | Experimental | Participants will receive the first intravenous (IV) infusion of IVIG on Day 1 up to a net dose of 2 gram per kilogram (g/kg), based upon participant's (body weight) administered in divided doses as infusions of 500 milligram per kilogram (mg/kg), based upon participant's body weight, over 4 days or 400 mg/kg, based upon participant's body weight, over 5 days. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
|
| Standard Medical Treatment | Active Comparator | Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Immune Globulin | Biological | IVIG Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Dying or Requiring ICU Admission | Up to Day 29 | |
| Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation | Day 29 |
| 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:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Sofía | San Sebastián de los Reyes | Madrid | 28702 | Spain | ||
| Hospital Germans Trias i Pujol |
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| Standard Medical Treatment | Drug | SMT |
|
| 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 |
| Length of Time to Clinical Progression | Up to Day 29 |
| Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale | Day 15 and Day 29 |
| Time to Sustained Normalization of Temperature | Day 1 through Day 29 |
| Percentage of Participants with Normalization of Fever | Day 1 through Day 29 |
| Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) | Day 29 |
| Badalona |
| 08916 |
| Spain |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | CP 08041 | Spain |
| Hospital Universitario de Getafe | Getafe | 28905 | Spain |
| Hospital Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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