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Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (active) APN01 | Active Comparator | Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01 |
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| Group B (placebo control) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhACE2 APN01 | Drug | Patients will be treated with APN01 intravenously twice daily (BID). |
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| Measure | Description | Time Frame |
|---|---|---|
| All Cause-death or Invasive Mechanical Ventilation | The primary endpoint was a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Dehydrogenase (LDH) Level | Log transformed levels of LDH at Day 5 as a surrogate marker for organ damage (powered secondary endpoint). | Day 5 |
| Mortality | 28-day mortality (all cause-death). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Bundgaard, MD. | Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | Austria | ||||
| Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37562051 | Derived | Chene A, Desrames A, Tomlinson A, Ruffie C, Tangy F, Gamain B. An ACE2-Based Bimodular Fusion Protein Enables Reorientation of Endogenous Anti-Epstein-Barr Virus Antibodies Toward SARS-CoV-2 Spike. J Infect Dis. 2023 Dec 20;228(12):1675-1679. doi: 10.1093/infdis/jiad329. | |
| 36796097 | Derived | Morrell ED. Tipping the Balance of Ubiquitination toward a Therapy for COVID-19. Am J Respir Cell Mol Biol. 2023 May;68(5):480-481. doi: 10.1165/rcmb.2023-0020ED. No abstract available. |
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185 Patients were screened of whom 181 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Active) APN01 | Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID). |
| FG001 | Group B (Placebo Control) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 10, 2020 | Jun 7, 2021 |
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| Physiological saline solution | Drug | Patients will be treated with placebo intravenously twice daily (BID). |
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| 28 days |
| Ventilator-free Days (VFD) | VFD up to 28 days or hospital discharge. VFD and mechanical-VFD (mVFD) were calculated as time in the study minus duration of ventilation and were set to zero if the duration of ventilation exceeded the time in the study. Three analysis approaches were used: 1) Death not censored: (m)VFD was set to zero for patients who died. 2) Death censored: patients who died before or on Day 28 were censored at the day before death. 3) Alive patients analyzed: only patients who were alive at Day 28, hospital discharge, or early termination were included in the analysis. | 28 days |
| Time to Death | Time to death (all causes). | 28 days |
| Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28 | The WHO Clinical Progression Scale provides a measure of illness severity across an 11 point range from 0 (not infected) to 10 (dead) as follows (scores 4-9 contain measures of respiratory failure): Uninfected, no viral deoxyribonucleic acid (DNA) detected = 0; Asymptomatic, viral DNA detected = 1; Symptomatic, independent = 2; Symptomatic, assistance needed = 3; Hospitalized, no oxygen therapy = 4; Hospitalized, oxygen by mask or nasal prongs = 5; Hospitalized, oxygen by non-invasive ventilation (NIV) or high flow = 6; Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2)≥ 150 or oxygen saturation (SpO2)/FiO2≥200 = 7; Mechanical ventilation, pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors = 8; Mechanical ventilation, pO2/FiO2 < 150 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) = 9; Dead = 10. A decrease in the score reflects an improvement. | Day 7, Day 10, Day 14, Day 28 |
| Time to Hospital Discharge | The number of days from randomization to discharge from hospital was calculated (Kaplan-Meier analysis). Patients without hospitalization or without documented hospital discharge who completed the study or were early terminated before Day 28 were censored at the date of study completion or discontinuation, respectively. Patients who died before Day 28 were censored at the date of death even if early terminated before. | Up to 28 days |
| Viral Ribonucleic Acid (RNA). | Viral RNA was assessed in blood samples using quantitative reverse transcriptase polymerase chain reaction (RT-PCR) and projected to RNA copies per mL. | Day 1, Day 3, Day 5, Day 7, Day 14, and Day 28/End of study (EOS) |
| Time to a 2-point Decrease in WHO's 11-Point Score System | The time from randomization to an at least 2-point decrease in the WHO scale was calculated. The WHO Clinical Progression Scale provides a measure of illness severity across an 11 point range from 0 (not infected) to 10 (dead) as follows (scores 4-9 contain measures of respiratory failure): Uninfected, no viral DNA detected = 0; Asymptomatic, viral DNA detected = 1; Symptomatic, independent = 2; Symptomatic, assistance needed = 3; Hospitalized, no oxygen therapy = 4; Hospitalized, oxygen by mask or nasal prongs = 5; Hospitalized, oxygen by non-invasive ventilation (NIV) or high flow = 6; Intubation and mechanical ventilation, pO2/FiO2 ≥ 150 or SpO2/FiO2≥200 = 7; Mechanical ventilation, pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors = 8; Mechanical ventilation, pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO = 9; Dead = 10. A decrease in the score reflects an improvement in disease status. | Up to 28 days. |
| Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge | The number of patients receiving mechanical ventilation and supplemental oxygen was evaluated. | Up to 28 days |
| Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge | Time from randomization to first use of invasive mechanical ventilation was calculated (Kaplan-Meier analysis). Patients without documented invasive mechanical ventilation who completed the study, were early terminated or discharged from hospital before Day 28 were censored at the date of study completion, discontinuation or discharge from hospital, respectively. | Up to 28 days |
| PaO2/FiO2 Value | The ratio in partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) was assessed by analysis of patient's blood gas. | Day 1, Day 7, Day 10, Day 14, and Day 28 |
| Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score) | The mSOFA score predicts intensive care unit mortality using clinical and laboratory variables. 5 organ systems (respiratory SpO2/FiO2; liver; cardiovascular/hypotension; Central nervous System/Glasgow Coma Score; renal/creatinine), all, except for liver, scored on a 0 to 4 scale (liver: 2-point scale: 0 or 3) according to specified criteria indicating severity, with the total score ranging from 0 to a maximum score of 19. A higher score reflects a worse disease state. | Day -1 (Screening), Day 7, Day 10, Day 14, Day 28/End of study |
| Lymphocyte Count | Lymphocytes were assessed in blood samples from the patients. | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
| C-reactive Protein Levels | C-reactive protein was assessed in blood samples from the patients. | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
| D-Dimer | D-Dimer was assessed in blood samples from the patients. | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
| Log-transformed Levels of LDH | Log transformed levels of LDH in blood were assessed as a surrogate marker for organ damage. | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
| Vienna |
| Austria |
| Medizinische Universität Wien | Vienna | Austria |
| The National University Hospital, Rigshospitalet | Copenhagen | Denmark |
| Herlev Gentofte Hospital | Herlev | 2730 | Denmark |
| Nordsjællands Hospital | Hillerød | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Klinikum rechts der Isar, Technische Universität München | München | Germany |
| Regional State Budgetary Educational Institution "Clinical Hospital № 5, Barnaul" | Barnaul | 656045 | Russia |
| State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov" | Moscow | 111539 | Russia |
| Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow" | Moscow | 123182 | Russia |
| Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow" | Moscow | 129090 | Russia |
| Saint Petersburg SBHI City Hospital 38 named after N A Semashko | Pushkin | 196600 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF | Ryazan | 390026 | Russia |
| Alexandrovskaya Hospital | Saint Petersburg | 193312 | Russia |
| Saint-Petersburg State Budget Healthcare Institution City Hospital 15 | Saint Petersburg | 198205 | Russia |
| Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF | Saratov | 410054 | Russia |
| Regional State Budgetary Healthcare Institution "Clinical Hospital №1" | Smolensk | 214006 | Russia |
| State budgetary institution of Healthcare of Tver region "Regional clinical hospital" | Tver' | 170036 | Russia |
| Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing" | Yaroslavl | 150047 | Russia |
| Cambridge University Hospitals NHS Trust/University of Cambridge | Cambridge | CB2 0QQ | United Kingdom |
Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID).
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized patients who received at least 1 dose of investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Active) APN01 | Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID). |
| BG001 | Group B (Placebo Control) | Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Data of 1 patient in the placebo group are missing. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | All Cause-death or Invasive Mechanical Ventilation | The primary endpoint was a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge. | All randomized patients who had received at least 1 dose of investigational medicinal product (IMP). | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Lactate Dehydrogenase (LDH) Level | Log transformed levels of LDH at Day 5 as a surrogate marker for organ damage (powered secondary endpoint). | All randomized patients who had received at least 1 dose of IMP and had an LDH measurement at Day 5. | Posted | Mean | Standard Deviation | Log U/L | Day 5 |
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| Secondary | Mortality | 28-day mortality (all cause-death). | All randomized patients who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Ventilator-free Days (VFD) | VFD up to 28 days or hospital discharge. VFD and mechanical-VFD (mVFD) were calculated as time in the study minus duration of ventilation and were set to zero if the duration of ventilation exceeded the time in the study. Three analysis approaches were used: 1) Death not censored: (m)VFD was set to zero for patients who died. 2) Death censored: patients who died before or on Day 28 were censored at the day before death. 3) Alive patients analyzed: only patients who were alive at Day 28, hospital discharge, or early termination were included in the analysis. | All randomized patients who had received at least 1 dose of IMP. In addition, a subgroup analysis was performed including only patients who were still alive at Day 28 (or discharged from the hospital/early terminated). | Posted | Mean | Standard Deviation | days | 28 days |
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| Secondary | Time to Death | Time to death (all causes). | All randomized patients who had received at least 1 dose of IMP. | Posted | Median | Full Range | days | 28 days |
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| Secondary | Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28 | The WHO Clinical Progression Scale provides a measure of illness severity across an 11 point range from 0 (not infected) to 10 (dead) as follows (scores 4-9 contain measures of respiratory failure): Uninfected, no viral deoxyribonucleic acid (DNA) detected = 0; Asymptomatic, viral DNA detected = 1; Symptomatic, independent = 2; Symptomatic, assistance needed = 3; Hospitalized, no oxygen therapy = 4; Hospitalized, oxygen by mask or nasal prongs = 5; Hospitalized, oxygen by non-invasive ventilation (NIV) or high flow = 6; Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2)≥ 150 or oxygen saturation (SpO2)/FiO2≥200 = 7; Mechanical ventilation, pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors = 8; Mechanical ventilation, pO2/FiO2 < 150 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) = 9; Dead = 10. A decrease in the score reflects an improvement. | All randomized patients who had received at least 1 dose of IMP and who had a measurement of the WHO 11-Point Score System at the respective timepoint. | Posted | Count of Participants | Participants | Day 7, Day 10, Day 14, Day 28 |
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| Secondary | Time to Hospital Discharge | The number of days from randomization to discharge from hospital was calculated (Kaplan-Meier analysis). Patients without hospitalization or without documented hospital discharge who completed the study or were early terminated before Day 28 were censored at the date of study completion or discontinuation, respectively. Patients who died before Day 28 were censored at the date of death even if early terminated before. | All patients who had received at least 1 dose of IMP. | Posted | Median | 95% Confidence Interval | days | Up to 28 days |
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| Secondary | Viral Ribonucleic Acid (RNA). | Viral RNA was assessed in blood samples using quantitative reverse transcriptase polymerase chain reaction (RT-PCR) and projected to RNA copies per mL. | All randomized patients who had received at least 1 dose of IMP and who had a measurement of viral RNA at the respective timepoint. | Posted | Mean | Standard Deviation | copies/mL | Day 1, Day 3, Day 5, Day 7, Day 14, and Day 28/End of study (EOS) |
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| Secondary | Time to a 2-point Decrease in WHO's 11-Point Score System | The time from randomization to an at least 2-point decrease in the WHO scale was calculated. The WHO Clinical Progression Scale provides a measure of illness severity across an 11 point range from 0 (not infected) to 10 (dead) as follows (scores 4-9 contain measures of respiratory failure): Uninfected, no viral DNA detected = 0; Asymptomatic, viral DNA detected = 1; Symptomatic, independent = 2; Symptomatic, assistance needed = 3; Hospitalized, no oxygen therapy = 4; Hospitalized, oxygen by mask or nasal prongs = 5; Hospitalized, oxygen by non-invasive ventilation (NIV) or high flow = 6; Intubation and mechanical ventilation, pO2/FiO2 ≥ 150 or SpO2/FiO2≥200 = 7; Mechanical ventilation, pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors = 8; Mechanical ventilation, pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO = 9; Dead = 10. A decrease in the score reflects an improvement in disease status. | All randomized patients who had received at least 1 dose of IMP. | Posted | Median | 95% Confidence Interval | days | Up to 28 days. |
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| Secondary | Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge | The number of patients receiving mechanical ventilation and supplemental oxygen was evaluated. | All randomized patients who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | Up to 28 days |
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| Secondary | Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge | Time from randomization to first use of invasive mechanical ventilation was calculated (Kaplan-Meier analysis). Patients without documented invasive mechanical ventilation who completed the study, were early terminated or discharged from hospital before Day 28 were censored at the date of study completion, discontinuation or discharge from hospital, respectively. | All randomized patients who had received at least 1 dose of IMP. | Posted | Median | Full Range | days | Up to 28 days |
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| Secondary | PaO2/FiO2 Value | The ratio in partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) was assessed by analysis of patient's blood gas. | All randomized patients who had received at least 1 dose of IMP and who had a measurement of PaO2/FiO2 at the respective timepoint. | Posted | Mean | Standard Deviation | mmHg | Day 1, Day 7, Day 10, Day 14, and Day 28 |
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| Secondary | Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score) | The mSOFA score predicts intensive care unit mortality using clinical and laboratory variables. 5 organ systems (respiratory SpO2/FiO2; liver; cardiovascular/hypotension; Central nervous System/Glasgow Coma Score; renal/creatinine), all, except for liver, scored on a 0 to 4 scale (liver: 2-point scale: 0 or 3) according to specified criteria indicating severity, with the total score ranging from 0 to a maximum score of 19. A higher score reflects a worse disease state. | All randomized patients who had received at least 1 dose of IMP and who had a measurement of the mSOFA score at the respective timepoint. | Posted | Mean | Standard Error | score on a scale | Day -1 (Screening), Day 7, Day 10, Day 14, Day 28/End of study |
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| Secondary | Lymphocyte Count | Lymphocytes were assessed in blood samples from the patients. | All randomized patients who had received at least 1 dose of IMP and who had a measurement of lymphocyte count at the respective timepoint. | Posted | Mean | Standard Deviation | 10^9 cells/L | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
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| Secondary | C-reactive Protein Levels | C-reactive protein was assessed in blood samples from the patients. | All randomized patients who had received at least 1 dose of IMP and who had a C-reactive protein measurement at the respective timepoint. | Posted | Mean | Standard Deviation | mg/L | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
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| Secondary | D-Dimer | D-Dimer was assessed in blood samples from the patients. | All randomized patients who had received at least 1 dose of IMP and who had a D-Dimer measurement at the respective timepoint. | Posted | Mean | Standard Deviation | µg/L | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
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| Secondary | Log-transformed Levels of LDH | Log transformed levels of LDH in blood were assessed as a surrogate marker for organ damage. | All randomized patients who had received at least 1 dose of IMP and who had an LDH measurement at the respective timepoints. | Posted | Mean | Standard Error | Log U/L | Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study |
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28 days
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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 | Group A (Active) APN01 | Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID). | 9 | 88 | 10 | 88 | 14 | 88 |
| EG001 | Group B (Placebo Control) | Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID). | 7 | 90 | 12 | 90 | 24 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General physical health deterioration | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Infarction | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Romana Gugenberger | APEIRON Biologics AG | +4366488506236 | romana.gugenberger@apeiron-biologics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2021 | Jun 7, 2021 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711750 | alunacedase alfa |
Not provided
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| Germany |
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| Russia |
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| Regression, Logistic | Degree of freedom: 1 | 0.3588 | Odds Ratio (OR) | 0.63 | 2-Sided | 95 | 0.23 | 1.70 | Other |
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Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID). |
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