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| Name | Class |
|---|---|
| University of Arizona | OTHER |
| Universidad Católica de Santa María | OTHER |
| Hospital Nacional Adolfo Guevara Velasco | OTHER |
| Hospital Nacional Edgardo Rebagliati Martins |
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The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease ([CKD]) to improve clinical outcomes in patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate + Usual Care | Experimental | The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation |
|
| Placebo + Usual Care | Placebo Comparator | The randomized intervention will a matching placebo, in combination with usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate/fenofibric acid | Other | The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Hierarchical Composite Endpoint | The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Alive, Out of the Intensive Care Unit, Free of Mechanical Ventilation/Extracorporeal Membrane Oxygenation, or Maximal Available Respiratory Support in the 30 Days Following Randomization | Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Death | Death from any cause during the observation period | Up to 30 days |
| Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization | Number of days that participants were alive and out of the hospital during the 30 days following randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091533 | Background | Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. | |
| 32242089 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fenofibrate + Usual Care | The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care |
| FG001 | Placebo + Usual Care | The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fenofibrate + Usual Care | The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical 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 | Primary Hierarchical Composite Endpoint | The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale | Posted | Median | Inter-Quartile Range | Ranked Severity Score | 30 days |
|
30 days post-randomization
The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category.
The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
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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 | Fenofibrate + Usual Care | The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intensive Care Unit Transfer | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney | Renal and urinary disorders | Systematic Assessment |
The study enrolled participants over an 18-month period where several different SARS-CoV-2 variants dominated, and national interventions and vaccine availability varied at different timepoints. Additionally, components of the hierarchical endpoints may be subjective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Greene | University of Pennsylvania | 215-662-7580 | katherine.greene@pennmedicine.upenn.edu |
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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 | Nov 3, 2021 | Dec 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2022 | Dec 23, 2022 | SAP_001.pdf |
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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 |
|---|---|
| D011345 | Fenofibrate |
| C006012 | fenofibric acid |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| OTHER |
| Hospital Nacional Alberto Sabogal Sologuren | OTHER |
| Hospital Nacional Guillermo Almenara Irigoyen | OTHER |
| Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud | OTHER |
| Universidad de Santander | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| Hospital Civil de Guadalajara | OTHER |
| Hospital Nacional Dos De Mayo | OTHER |
| Hospital Central Fuerza Aérea del Perú | OTHER |
| Hospital Militar Central.Coronel Luis Arias Schereiber | OTHER |
| Hospital Victor Lazarte Echegaray | OTHER |
| University Hospital, Ioannina | OTHER |
| AHEPA University Hospital | OTHER |
| Sotiria Thoracic Diseases Hospital of Athens | OTHER |
| Thriasio General Hospital of Elefsina | OTHER |
| University Hospital, Alexandroupolis | OTHER |
| G.Gennimatas General Hospital | OTHER |
| Biomelab S.A.S. | INDUSTRY |
| Fundación Oftalmológica de Santander. Santander, Colombia | OTHER |
| IPS Centro Científico Asistencial. Barranquilla, Colombia | OTHER |
| Fundación Cardiomet. Quindio, Colombia | OTHER |
| ClÍnica de Marly | OTHER |
| Clínica Internacional | OTHER |
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|
| Placebo | Other | The control intervention will be a placebo, for 10 days. |
|
| Usual care | Other | All participants will otherwise receive usual medical care |
|
| Up to 30 days |
| Seven-category Ordinal Scale | A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death. | At 15 days |
| Secondary Hierarchical Composite Endpoint | The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed). | Up to 30 days |
| Up to 30 days |
| Exploratory Hierarchical Composite Endpoint | The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization. | Up to 30 days |
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| 12595630 | Background | Feher MD, Hepburn AL, Hogarth MB, Ball SG, Kaye SA. Fenofibrate enhances urate reduction in men treated with allopurinol for hyperuricaemia and gout. Rheumatology (Oxford). 2003 Feb;42(2):321-5. doi: 10.1093/rheumatology/keg103. |
| 15481999 | Background | Schlesinger N. Management of acute and chronic gouty arthritis: present state-of-the-art. Drugs. 2004;64(21):2399-416. doi: 10.2165/00003495-200464210-00003. |
| 16913436 | Background | Lee YH, Lee CH, Lee J. Effect of fenofibrate in combination with urate lowering agents in patients with gout. Korean J Intern Med. 2006 Jun;21(2):89-93. doi: 10.3904/kjim.2006.21.2.89. |
| 30425304 | Background | Jung JY, Choi Y, Suh CH, Yoon D, Kim HA. Effect of fenofibrate on uric acid level in patients with gout. Sci Rep. 2018 Nov 13;8(1):16767. doi: 10.1038/s41598-018-35175-z. |
| 29571506 | Background | Khanna PP. Gout: a patrician malady no more. Lancet Diabetes Endocrinol. 2018 Apr;6(4):263-264. doi: 10.1016/S2213-8587(18)30073-1. No abstract available. |
| 29496472 | Background | Waldman B, Ansquer JC, Sullivan DR, Jenkins AJ, McGill N, Buizen L, Davis TME, Best JD, Li L, Feher MD, Foucher C, Kesaniemi YA, Flack J, d'Emden MC, Scott RS, Hedley J, Gebski V, Keech AC; FIELD investigators. Effect of fenofibrate on uric acid and gout in type 2 diabetes: a post-hoc analysis of the randomised, controlled FIELD study. Lancet Diabetes Endocrinol. 2018 Apr;6(4):310-318. doi: 10.1016/S2213-8587(18)30029-9. Epub 2018 Feb 26. |
| Background | Ting R-D, Keech A. Fenofibrate and renal disease: clinical effects in diabetes. Clinical Lipidology. 2013;8(6):669-680 |
| 11847949 | Background | McDonald KB, Garber BG, Perreault MM. Pancreatitis associated with simvastatin plus fenofibrate. Ann Pharmacother. 2002 Feb;36(2):275-9. doi: 10.1345/aph.1A180. |
| 21094360 | Background | Enger C, Gately R, Ming EE, Niemcryk SJ, Williams L, McAfee AT. Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. Am J Cardiol. 2010 Dec 1;106(11):1594-601. doi: 10.1016/j.amjcard.2010.07.041. Epub 2010 Oct 14. |
| 36344766 | Derived | Chirinos JA, Lopez-Jaramillo P, Giamarellos-Bourboulis EJ, Davila-Del-Carpio GH, Bizri AR, Andrade-Villanueva JF, Salman O, Cure-Cure C, Rosado-Santander NR, Cornejo Giraldo MP, Gonzalez-Hernandez LA, Moghnieh R, Angeliki R, Cruz Saldarriaga ME, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori JE, Gomez-Laiton E, Cotrina Pereyra R, Ravelo Hernandez JL, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis C, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia RJ, Castro-Callirgos CA, Alfaro Carrasco RM, Garrido Lecca Danos W, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Ortega-Legaspi J, Jacoby D, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer NK, Putt M, Cohen JB; FERMIN Investigators. A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019. Nat Metab. 2022 Dec;4(12):1847-1857. doi: 10.1038/s42255-022-00698-3. Epub 2022 Nov 7. |
| 35982675 | Derived | Chirinos J, Lopez-Jaramillo P, Giamarellos-Bourboulis E, Davila-Del-Carpio G, Bizri A, Andrade-Villanueva J, Salman O, Cure-Cure C, Rosado-Santander N, Giraldo MC, Gonzalez-Hernandez L, Moghnieh R, Angeliki R, Saldarriaga MC, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori J, Gomez-Laiton E, Pereyra R, Hernandez JR, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis H, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia R, Castro-Callirgos C, Carrasco RA, Danos WL, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer N, Putt M, Cohen J. A Randomized Trial of Lipid Metabolism Modulation with Fenofibrate for Acute Coronavirus Disease 2019. Res Sq [Preprint]. 2022 Aug 10:rs.3.rs-1933913. doi: 10.21203/rs.3.rs-1933913/v1. |
| BG001 | Placebo + Usual Care | The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Borg Scale | This is a scale that asks participants to rate the difficulty of their breathing. The scale starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. The total Borg scale is reported. Please see the following reference for additional information: https://www.cdc.gov/physicalactivity/basics/measuring/exertion.htm | Mean | Standard Deviation | units on a scale |
|
The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care |
| OG001 | Placebo + Usual Care | The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care |
|
|
| Secondary | Number of Days Alive, Out of the Intensive Care Unit, Free of Mechanical Ventilation/Extracorporeal Membrane Oxygenation, or Maximal Available Respiratory Support in the 30 Days Following Randomization | Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization | Posted | Mean | Standard Deviation | days | Up to 30 days |
|
|
|
| Secondary | Seven-category Ordinal Scale | A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death. | Posted | Median | Inter-Quartile Range | score on a scale | At 15 days |
|
|
|
| Secondary | Secondary Hierarchical Composite Endpoint | The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed). | Posted | Median | Inter-Quartile Range | score on a scale | Up to 30 days |
|
|
|
| Other Pre-specified | All-Cause Death | Death from any cause during the observation period | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Other Pre-specified | Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization | Number of days that participants were alive and out of the hospital during the 30 days following randomization | Posted | Median | Inter-Quartile Range | days | Up to 30 days |
|
|
|
| Other Pre-specified | Exploratory Hierarchical Composite Endpoint | The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 30 days |
|
|
|
| 19 |
| 351 |
| 46 |
| 351 |
| 74 |
| 351 |
| EG001 | Placebo + Usual Care | The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care | 22 | 350 | 61 | 350 | 55 | 350 |
| Death | General disorders | Systematic Assessment |
|
| Invasive mechanical ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| New or worsening cognitive status | Psychiatric disorders | Systematic Assessment |
|
| Liver failure or acute liver injury | Hepatobiliary disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Suspected or confirmed rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Worsening dyspnea or hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Superimposed infection | Infections and infestations | Systematic Assessment |
|
| New or worsening diarrhea, nausea, or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Other new or worsening neurologic issues | Nervous system disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Hepatic | Hepatobiliary disorders | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastroenterologic | Gastrointestinal disorders | Systematic Assessment |
|
| Infectious | Infections and infestations | Systematic Assessment |
|
| Neurologic | Nervous system disorders | Systematic Assessment |
|
| Dermatologic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Endocrinologic | Endocrine disorders | Systematic Assessment |
|
| Hematologic | Blood and lymphatic system disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |