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The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.
Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruconest | Experimental | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. |
|
| Standard of Care | Other | SOC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruconest | Drug | Patients will be randomized to Ruconest or Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7 | The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death. | Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Improvement | Time from randomization to an improvement of (at least) two (score) points on the seven-category WHO Ordinal Scale or live discharge from hospital whichever came first within 14 days after enrollment | Daily until day 14 |
| Invasive (Mechanical) or Non-invasive Ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bernstein, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtua Marlton Hospital | Marlton | New Jersey | 08053 | United States | ||
| Virtua Memorial Hospital |
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Participants were randomized to two parallel groups in a 2:1 ratio to receive either rhC1INH (intervention) in addition to standard of care (SOC) or SOC treatment (control). Randomization was stratified by the study site before inclusion using randomly permuted block sizes of four.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruconest | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. Ruconest: Patients will be randomized to Ruconest or Standard of Care |
| FG001 | Standard of Care | SOC Ruconest: Patients will be randomized to Ruconest or Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analyzed (FAS/ITT - Interim analysis/Overrunning analysis) in interim analysis phase: rhC1INH plus SOC [n=23]; SOC alone [n=9]. A subsequent (post hoc) analysis was conducted to include all 38 patients, overrunning analysis phase: rhC1INH plus SOC [n=27]; SOC alone [n=11].
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruconest | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. Ruconest: Patients will be randomized to Ruconest or Standard of Care |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7 | The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death. | Posted | Count of Participants | Participants | Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value |
|
From signing off ICF till 90 days follow-up period Adverse event date were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruconest | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. Ruconest: Patients will be randomized to Ruconest or Standard of Care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anurag Relan, MD | Pharming Technologies BV | 0031 (0)71 5247400 | a.relan@pharming.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2021 | Feb 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2021 | Feb 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C571093 | conestat alfa |
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Admission to ICU with invasive or non-invasive ventilation will be assessed. |
| Daily until day 14. |
| Number of Days Hospitalized | Amount of days the patient is hospitalized during participation in the study. | between D0 and D90 |
| Mount Holly |
| New Jersey |
| 08060 |
| United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Virtua Voorhees Hospital | Voorhees Township | New Jersey | 08043 | United States |
| Death |
|
SOC Ruconest: Patients will be randomized to Ruconest or Standard of Care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Standard of Care | SOC Ruconest: Patients will be randomized to Ruconest or Standard of Care |
|
|
|
| Secondary | Time to Clinical Improvement | Time from randomization to an improvement of (at least) two (score) points on the seven-category WHO Ordinal Scale or live discharge from hospital whichever came first within 14 days after enrollment | Posted | Mean | Standard Error | days | Daily until day 14 |
|
|
|
|
| Secondary | Invasive (Mechanical) or Non-invasive Ventilation | Admission to ICU with invasive or non-invasive ventilation will be assessed. | Posted | Count of Participants | Participants | Daily until day 14. |
|
|
|
|
| Secondary | Number of Days Hospitalized | Amount of days the patient is hospitalized during participation in the study. | Posted | Mean | Standard Deviation | days | between D0 and D90 |
|
|
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| 23 |
| 27 |
| EG001 | Standard of Care | SOC Ruconest: Patients will be randomized to Ruconest or Standard of Care | 1 | 11 | 2 | 11 | 11 | 11 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Blood beta-D-glucan increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Fibrin D Dimer increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Transaminitis | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Respiratory failure [Death] | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Shock | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase inc | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Transaminitis | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
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