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Met futility bar at interim analysis
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This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Ravulizumab + BSC | Experimental |
| |
| Group 2 - BSC alone | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravulizumab | Biological | Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Days Free Of Mechanical Ventilation At Day 29 | The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation. | Day 29 |
| Number of Days the Participants Were Alive and Not in ICU |
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Inclusion Criteria:
Exclusion Criteria:
Participant was not expected to survive for more than 24 hours.
Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
Participant had an unresolved Neisseria meningitidis infection.
Used the following medications and therapies:
Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions:
Female participants who were breastfeeding or who have a positive pregnancy test result at Screening.
History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the participant receives vaccination against Neisseria meningitidis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | 72205 | United States | ||
| LAC/USC Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020. | ||
| 33826106 | Result | McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7. | |
| 32660611 |
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Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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Of the 210 participants screened, 8 (3.8%) participants were screen failures. A total of 202 participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Ravulizumab + BSC | Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols. |
| FG001 | Group 2 - BSC Alone |
| 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 | Jun 9, 2020 | Feb 15, 2022 |
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| BSC | Other | Participants received medications, therapies, and interventions per standard hospital treatment protocols. |
|
The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented. |
| Day 1 through Day 29 |
| Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition. | Baseline, Day 29 |
| Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point. | Baseline, Day 29 |
| Number of Days the Participants Were Alive and Not in the Hospital | The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented. | Day 1 through Day 29 |
| Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 | For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section. | Up to Day 60 and Up to Day 90 |
| Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 | Results are reported in micrograms/milliliter (μg/mL). | Day 1 and Day 29 |
| Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29 | Baseline, Day 29 |
| Change From Baseline In Terminal Complement Complex C5b-9 At Day 29 | Baseline, Day 29 |
| Los Angeles |
| California |
| 90033 |
| United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| University of Florida | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic Health System | Mankato | Minnesota | 56001 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| NYU Langone Health Center | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Mayo Clinic Health System in Eau Claire | Eau Claire | Wisconsin | 54703 | United States |
| Mayo Clinic Health System | La Crosse | Wisconsin | 54601 | United States |
| Hôpital Raymond Poincaré | Garches | Hauts De Seine | 92380 | France |
| Hôpital Henri Mondor | Créteil | Val De Marne | 94000 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | Val De Marne | 94275 | France |
| Jikei University Hospital | Minato-Ku | Tokyo | 105-8471 | Japan |
| Tokyo Medical University Hospital | Shinjuku-Ku | Tokyo | 160-0023 | Japan |
| Medical Hospital, Tokyo Medical and Dental University | Bunkyō City | Tokyo-To | 113-8519 | Japan |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| King's College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| Hammersmith Hospital | London | Greater London | W12 0HS | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | Merseyside | L7 8XP | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | West Midlands | B15 2TH | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Result |
| Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z. |
| 36958364 | Derived | Annane D, Pittock SJ, Kulkarni HS, Pickering BW, Khoshnevis MR, Siegel JL, Powell CA, Castro P, Fujii T, Dunn D, Smith K, Mitter S, Kazani S, Kulasekararaj A. Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2023 Dec;11(12):1051-1063. doi: 10.1016/S2213-2600(23)00082-6. Epub 2023 Mar 20. |
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| 32554923 | Derived | Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15):e140711. doi: 10.1172/jci.insight.140711. |
Participants received medications, therapies, and interventions per standard hospital treatment protocols |
| Intent to Treat (ITT) Population | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. |
|
| Pharmacokinetic (PK) | The PK Set included participants in the ITT population with at least one postdose PK result. |
|
| Safety Population | All randomized participants who received at least 1 dose of study drug. Participants were analyzed as treated. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Ravulizumab + BSC | Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols. |
| BG001 | Group 2 - BSC Alone | Participants received medications, therapies, and interventions per standard hospital treatment protocols |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. | Posted | Number | Percentage of participants | Day 29 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Of Days Free Of Mechanical Ventilation At Day 29 | The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Days | Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days the Participants Were Alive and Not in ICU | The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Days | Day 1 through Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days the Participants Were Alive and Not in the Hospital | The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Days | Day 1 through Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 | For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section. | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, "Number Analyzed" signifies those participants who were evaluable for the assessment at the specified time frame. | Posted | Count of Participants | Participants | Up to Day 60 and Up to Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 | Results are reported in micrograms/milliliter (μg/mL). | Pharmacokinetics/Pharmacodynamics (PK/PD) Population: participants in the ITT population with at least 1 postdose PK or PD result. | Posted | Mean | Standard Deviation | μg/mL | Day 1 and Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29 | PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | μg/mL | Baseline, Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Terminal Complement Complex C5b-9 At Day 29 | PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ug/L | Baseline, Day 29 |
|
|
Day 1 through Day 90
Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
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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 1 - Ravulizumab + BSC | Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols. | 55 | 135 | 79 | 127 | 97 | 127 |
| EG001 | Group 2 - BSC Alone | Participants received medications, therapies, and interventions per standard hospital treatment protocols. | 25 | 66 | 38 | 67 | 49 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Microangiopathic haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Herpes simplex pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Blood beta-D-glucan positive | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Organizing pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Shock hemorrhagic | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2020 | Feb 15, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D011024 | Pneumonia, Viral |
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629409 | ravulizumab |
Not provided
Not provided
Not provided
| Male |
|
| Hispanic or Latino |
|
| Missing/Unknown |
|
| Not reported |
|
| Black or African American |
|
| Missing/Unknown |
|
| Other |
|
| Asian |
|
| Not Reported |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|