| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| CoVid-19 pneumonia in early inflammatory phase (stage II). |
| Neumonía CoVid-19 en fase inflamatoria precoz (estadío II). |
|
| E.1.1.1 | Medical condition in easily understood language |
| CoVid-19 pneumonia in early inflammatory phase (stage II). |
| Neumonía CoVid-19 en fase inflamatoria precoz (estadío II). |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| 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 assess the efficacy of glucocorticoid boluses in the inflammatory phase of SARS-CoV-2 pneumonia. |
| Evaluar la eficacia de los bolos de glucocorticoides en la fase inflamatoria de la neumonía por SARS-CoV-2. |
|
| E.2.2 | Secondary objectives of the trial |
• Compare mortality at 28 days.
• Compare the proportion of ICU admissions at 28 days.
• Compare the ratio need for rescue treatment with tocilizumab at 14 days.
• Compare the days of hospital admission.
• Compare the evolution of the analytical parameters of inflammation: C-reactive protein (PCR), interleukin 6 (IL-6), ferritin, D-dimer (DD).
• Compare the proportion of serious adverse events.
• Compare the proportion of bacterial, fungal, or opportunistic infections.
• Compare the clearance of the virus detected by nasopharyngeal PCR. |
•Comparar la mortalidad a los 28 días.
•Comparar la proporción de ingresos en UCI a los 28 días.
•Comparar la proporción necesidad de tratamiento de rescate con tocilizumab a los 14 días.
•Comparar los días de ingreso hospitalario.
•Comparar la evolución de los parámetros analíticos de inflamación: proteína C reactiva (PCR), interleuquina 6 (IL-6), ferritina, D-dímero (DD).
•Comparar la proporción de acontecimientos adversos graves.
•Comparar la proporción de infecciones bacterianas, fúngicas u oportunistas.
•Comparar el aclaramiento del virus detectado por PCR nasofaríngea.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Age ≥18 years.
• Diagnosis of SARS-CoV-2 pneumonia by reverse transcriptase polymerase chain reaction (RT-PCR) in nasopharyngeal or sputum smears according to the recommendations of the Ministry of Health.
• Duration of symptoms ≥ 7 days.
• At least one of the following: C-reactive protein (PCR)> 60 mg / L or interleukin 6 (IL-6)> 40 pg / mL or ferritin> 1000 μg / L.
• Acceptance of informed consent. |
•Edad ≥18 años.
•Diagnóstico de neumonía por SARS-CoV-2 mediante reacción en cadena de la polimerasa con transcriptasa inversa (RT-PCR) en frotis nasofaríngeo o esputo de acuerdo con las recomendaciones del Ministerio de Sanidad.
•Duración de los síntomas ≥ 7 días.
•Al menos una de las siguientes: proteína C reactiva (PCR) >60 mg/L o interleuquina 6 (IL-6) >40 pg/mL o ferritina >1000 μg/L.
•Aceptación del consentimiento informado.
|
|
| E.4 | Principal exclusion criteria |
• Allergy or contraindication to the drugs under study.
• Respiratory failure data: SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2 / FiO2 <300 mmHg.
• Need for glucocorticoids or immunosuppressants (including biological ones) with another indication.
• Decompensated diabetes mellitus.
• Uncontrolled hypertension.
• Psychotic or manic disorder.
• Active cancer.
• Pregnancy or lactation.
• Clinical or biochemical suspicion (procalcitonin> 0.5 ng / mL) of active infection other than SARS-CoV-2.
• Out-of-hospital management patient.
• Conservative or palliative management patient.
• Participation in another clinical trial.
• Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
|
• Alergia o contraindicación a los medicamentos en estudio.
• Datos de insuficiencia respiratoria: SpO2 <90% (a aire ambiente) o PaO2 <60 mmHg (a aire ambiente) o PaO2/FiO2 <300 mmHg.
• Necesidad de glucocorticoides o inmunosupresores (incluidos los biológicos) con otra indicación.
• Diabetes mellitus descompensada.
• Hipertensión arterial no controlada.
• Trastorno psicótico o maníaco.
• Cáncer activo.
• Embarazo o lactancia.
• Sospecha clínica o bioquímica (procalcitonina >0,5 ng/mL) de infección activa diferente a SARS-CoV-2.
• Paciente de manejo extrahospitalario.
• Paciente de manejo conservador o paliativo.
• Participación en otro ensayo clínico.
• Cualquier problema médico, psicológico, psiquiátrico, geográfico o social importante y no controlado que contraindique la participación del paciente en el ensayo o que no permitan un adecuado seguimiento y adherencia con el protocolo y evaluación de los resultados del estudio.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Proportion of patients with treatment failure up to 14 days after randomization.
Definition of treatment failure:
to. Death of the patient, or
b. ICU admission, or
c. Start of mechanical ventilation, or
d. Clinical deterioration / worsening, defined as decrease in SpO2 below 90% or PaO2 below 60 mmHg in ambient air + radiological progression. |
Proporción de pacientes con fallo de tratamiento hasta los 14 días después de la aleatorización.
Definición de fallo de tratamiento:
a. Muerte del paciente, o bien
b. Ingreso en UCI, o bien
c. Inicio de ventilación mecánica, o bien
d. Deterioro / empeoramiento clínico, definido como descenso de SpO2 por debajo de 90% o de PaO2 por debajo de 60 mmHg a aire ambiente + progresión radiológica.
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 14 DAYS OF HOSPITALISATION |
| 14 DÍAS DE HOSPITALIZACIÓN |
|
| E.5.2 | Secondary end point(s) |
• Mortality 28 days after randomization.
• Proportion of ICU admissions 28 days after randomization.
• Proportion of rescue treatment with tocilizumab or with methylprednisolone + tocilizumab 14 days after randomization.
• Days of hospital stay.
• Proportion of serious adverse events.
• Proportion of bacterial, fungal or opportunistic infections.
• Differences in the analytical parameters indicative of inflammation (PCR, IL-6, ferritin, D-dimer) 14 days after randomization.
• Clearance of the virus detected by nasopharyngeal RT-PCR at 7 days. |
• Mortalidad a los 28 días de la aleatorización.
• Proporción de ingresos en UCI a los 28 días de la aleatorización.
• Proporción de tratamiento de rescate con tocilizumab o con metilprednisolona + tocilizumab a los 14 días de la aleatorización.
• Días de estancia hospitalaria.
• Proporción de acontecimientos adversos graves.
• Proporción de infecciones bacterianas, fúngicas u oportunistas.
• Diferencias en los parámetros analíticos indicativos de inflamación (PCR, IL-6, ferritina, dímero D) a los 14 días de la aleatorización.
• Aclaramiento del virus detectado por RT-PCR nasofaríngea a los 7 días.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| 28 DAYS OF HOSPITALISATION |
| 28 DÍAS DE HOSPITALIZACIÓN |
|
| 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 | No |
| 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) | 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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 | Yes |
| E.8.2.3 | Other | No |
| 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 | Yes |
| 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
|
| LVLS |
| ULTIMA VISITA DEL ULTIMO SUJETO RECLUTADO |
|
| 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 | 4 |
| E.8.9.1 | In the Member State concerned days | |
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