E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with SARS-CoV-2 infection (COVID19) requiring hospital admission for pneumonia. Who present pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score [13] on admission > 200 with pcr 9.7-149 mg/L at inclusion. WHO scale level 4 [14], with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%.
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Pacientes adultos con infección por SARS-CoV-2 (COVID19) que requieren ingreso hospitalario por neumonía. Que presentan pcr ≥ 66 mg/L y ≤150 mg/L en el momento de la inclusión o Pandemic score [13] al ingreso > 200 con pcr 9.7-149 mg/L en el momento de la inclusión. Nivel 4 de la escala de la OMS [14], con necesidad de oxigenoterapia en GN ≥ 1 lpm para mantener saturación ≥ 94%. |
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E.1.1.1 | Medical condition in easily understood language |
Adult patients with COVID19 infection requiring hospital admission for pneumonia |
Pacientes adultos con infección por COVID19 que requieren ingreso hospitalario por neumonía |
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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 |
To evaluate whether there is a decrease in the proportion of patients who develop respiratory distress requiring NIV/MIV/OCNAF (measured group and individually by respiratory therapies). To assess whether there is an impact of such a strategy on the number of days of hospitalization.
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Evaluar si hay una disminución de la proporción de pacientes que desarrollan distrés respiratorio con necesidad de VMNI/VMI/OCNAF (medidos grupal e individualmente por terapias respiratorias) Evaluar si hay un impacto de dicha estrategia sobre el número de días de hospitalización |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether there is a decrease in NIV/MIV/OCNAF therapy days. Evaluate whether there is a decrease in 30-, 60-, and 90-day, all-cause mortality. Safety: related short- and long-term adverse events.
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Evaluar si hay una disminución de los días de terapia VMNI/VMI/OCNAF Evaluar si hay una disminución de mortalidad a 30, 60 y 90 días, por todas las causas Seguridad: eventos adversos a corto y largo plazo relacionados
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients admitted with SARS-CoV-2 pneumonia (COVID19) confirmed by antigenic test or PCR Age ≥ 18 years. presents with a pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score [13] at admission > 200 with pcr 9.7-149 mg/L at inclusion WHO scale level 4 [14], with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%. Onset of symptoms ≤ 10 days before the date of inclusion. |
Pacientes ingresados con neumonía por SARS-CoV-2 (COVID19) confirmados mediante test antigénico o PCR Edad ≥ 18 años presenta una pcr ≥ 66 mg/L y ≤150 mg/L en el momento de la inclusión o Pandemic score [13] al ingreso > 200 con pcr 9.7-149 mg/L en el momento de la inclusión Nivel 4 de la escala de la OMS [14], con necesidad de oxigenoterapia en GN ≥ 1 lpm para mantener saturación ≥ 94%. Inicio de los síntomas ≤ 10 días antes de la fecha de la inclusión.
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E.4 | Principal exclusion criteria |
Patients with criteria of respiratory distress at the time of randomisation, understood as need for OCNAF/NIMV/MIV (levels 5 and 6 of the WHO scale) or O2 saturation ≤ 92% and/or RF ≥ 30 despite oxygen in NG at 4 litres.
Patients with allergy or contraindication to the use of systemic corticosteroids.
Patients with severe asthma or chronic lung disease with home oxygen requirements and active corticosteroid therapy.
Patients on chronic corticosteroid therapy
Use of corticosteroids daily in the 15 days prior to hospital admission.
Indication for steroid use due to other clinical conditions of the patient (e.g. septic shock)
Pregnant or actively breastfeeding women
Patients with suspected or confirmed bacterial, fungal, or viral infection other than SARS-CoV-2 itself at time of randomisation
Patients with confirmed past or latent tuberculosis infection prior to inclusion.
Patients with known HIV infection with CD4 below 500 cells/mm3 or on active treatment with protease inhibitors or boosters such as cobicistat or ritonavir.
Patients with active oncological processes in the last year or on active treatment with chemotherapy.
Patients with life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia.
Patients expected to die within 48-72 hours.
Patients included in another clinical trial. |
Pacientes con criterio de distrés respiratorio en el momento de la randomización, entendido como necesidad de OCNAF/VMNI/VMI (niveles 5 y 6 de la escala de la OMS) o saturación de O2 ≤ 92% y/o FR ≥ 30 pese a oxígeno en GN a 4 litros.
Pacientes con alergia o contraindicación para el uso de corticoides sistémicos
Pacientes con asma grave o patología pulmonar crónica con requerimientos de oxigeno domiciliario y tratamiento activo con corticoides
Pacientes en tratamiento con corticoides de manera crónica
Uso de corticoides diariamente en los 15 días previos al ingreso hospitalario
Indicación de uso de corticoides por otras condiciones clínicas del paciente (por ejemplo, shock séptico)
Mujeres embarazadas o con lactancia activa
Pacientes con sospecha o confirmación de infección bacteriana, fúngica, o viriasis diferente del propio SARS-CoV-2 en el momento de la randomización
Pacientes con infección tuberculosa pasada o latente confirmada previo al momento de la inclusión.
Pacientes con infección por HIV conocida con CD4 por debajo de 500 cel/mm3 o en tratamiento activo con inhibidores de la proteasa o potenciadores como el cobicistat o ritonavir.
Pacientes con procesos oncológicos activos en el último año o en tratamiento activo con quimioterapia.
Pacientes con esperanza de vida < 3 meses en el momento de la inclusión por condiciones clínicas diferentes de la neumonía por SARS-CoV-2.
Pacientes con fallecimiento esperable en las siguientes 48-72 horas
Pacientes incluidos en otro ensayo clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Requirement of respiratory therapy with NIV/MIV/OCNAF Need for respiratory support with NIMV/MIV/OCNAF Days of hospitalization counted from signature of informed consent to time of discharge from hospital
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Requerimiento de terapia respiratoria con VMNI/VMI/OCNAF Necesidad de soporte respiratorio con VMNI/VMI/OCNAF Días de hospitalización contados desde la firma del consentimiento informado hasta el momento de abandono del hospital
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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) |
Days of respiratory therapy with NIV/MIV/OCNAF (counted individually and grouped in case they were sequential and consecutive). Mortality during admission and at 30, 60 and 90 days, from all causes. |
Días de terapia respiratoria con VMNI/VMI/OCNAF (contados de forma individual y agrupados en caso de que fueran secuenciales y consecutivas) Mortalidad durante el ingreso y a 30, 60 y 90 días, por todas las causas
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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 | No |
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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 |
diferentes dosis del mismo producto |
different dosage of the same product |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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LVLS |
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 | |