E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hospitalized patients with Covid-19 pneumonia who do not require oxygen therapy on admission associated with at least two of the three following factors related with severe Covid-19: lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L and lymphocyte count < 800 cells/µL. |
Pacientes hospitalizados por neumonía Covid-19 que no requieran suplemento de oxígeno al ingreso y presenten al menos dos de los siguientes criterios analíticos asociados a Covid-19 grave: láctico deshidrogenasa > 245 U/L, Proteína C Reactiva > 100 mg/L y recuento linfocitario < 800 céls/µL |
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E.1.1.1 | Medical condition in easily understood language |
Hospitalized patients with covid-19 pnemoniae |
Pacientes hospitalizados por neumonía Covid-19 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the trial is to prevent the moderate-severe acute respiratory distress syndrom |
El principal objetivo del estudio es prevenir el desarrollo de síndrome de distrés respiratorio agudo moderado-severo |
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E.2.2 | Secondary objectives of the trial |
- All-cause mortality within 28 days after randomization - Admission to the Intensive Care Unit or Intermediate Care Unit within 28 days after randomization - Clinical status of the patient using the World Health Organization ordinal scale - Clinical status of the patient using Sequential Organ Failure Assessme Score - Hospital stay - Respiratory support at hospital discharge - All-cause readmission within 3 months after randomization |
- Mortalidad por todas las causas durante los 28 días posteriores a la aleatorización - Necesidad de ingreso en la Unidad de Cuidados Intensivos o Unidad de cuidados intermedios durante los 28 días posteriores a la aleatorización - Situación clínica del paciente utilizando la escala ordinal de 8 niveles de la Organización Mundial de Salud - Situación clínica del paciente usando la escala Sequential Organ Failure Assessme Score - Estancia hospitalaria - Necesidad de soporte respiratorio al alta hospitalaria - Tasa de reingreso por cualquier causa durante los 3 meses posteriores a la aleatorización |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hospitalized patients with Covid-19 pneumonia who do not require oxygen therapy on admission associated with at least two of the three following factors related with severe Covid-19: lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L and lymphocyte count < 800 cells/µL. |
Pacientes hospitalizados por neumonía Covid-19 que no requieran suplemento de oxígeno al ingreso y presente al menos dos de los siguientes criterios analíticos asociados a Covid-19 grave: láctico deshidrogenasa > 245 U/L, Proteína C Reactiva > 100 mg/L y recuento linfocitario < 800 céls/µL |
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E.4 | Principal exclusion criteria |
Unconfirmed SARS-CoV-2 infection Pregnant or breastfeeding women Oral or inhaled corticosteroid therapy within 15 days before Oral or inhaled corticosteroid therapy for chronic medical condition Immunosuppressive therapy Cytotoxic chemotherapy within 30 days before Neutrophil count < 1000 cells/mm3 for hematologic malignancy or solid tumor Dementia or psychosis Human immunodeficiency virus infection Patients with liver disease defined as ALT or AST ≥ 5 times the upper limit of normal Patients with kidney disease defined as glomerular filtration rate ≤ 30 ml/min, hemodialysis or peritoneal dialysis Uncontrolled bacterial infection Drug use |
Infección no confirmada por SARS-CoV-2 Mujeres embarazadas o en periodo de lactancia Tratamiento diario con corticoides orales o inhalados en los últimos 15 días Tratamiento médico habitual con corticoides orales o inhalados para otras afecciones médicas Tratamiento con fármacos inmunosupresores Tratamiento con quimioterapia citotóxica en los últimos 30 días Recuento de neutrófilos < 1000 células/mm3 por neoplasia hematológica o tumor sólido Demencia o psicosis Infección por el virus de la inmunodeficiencia humana Pacientes con enfermedad hepática grave definida por ALT o AST ≥ 5 veces el límite superior de la normalidad Pacientes con insuficiencia renal grave (filtrado glomerular ≤ 30 ml/min), en hemodiálisis o diálisis peritoneal Sospecha de infección bacteriana grave no controlada Consumo de drogas |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary end point of this trial is do not require supplementary oxigen during hospitalization |
El end point primario de este ensayo es no requerir oxígeno suplementario durante el ingreso |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Mortality, admission to the Intensive Care Unit or Intermediate Care Unit, World Health Organization ordinal scale, Sequential Organ Failure Assessme Score, hospital stay and readmission |
Mortalidad, ingreso en Unidad de Cuidados Intensivos o ingreso en Unidad de Cuidados Intermedios, escala clínica de la Organización Mundial de la Salud, escala Sequential Organ Failure Assessme, estancia hospitalaria y tasa de reingreso |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Tratamiento habitual |
Standard care |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LPLV |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |