E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients infected with COVID19 |
Pacientes infectados con COVID19 |
|
E.1.1.1 | Medical condition in easily understood language |
Patients infected with COVID19 |
Pacientes infectados con COVID19 |
|
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 |
Provide reliable estimates of the effects of these antiviral treatments on hospital mortality. |
Proporcionar estimaciones fiables sobre los efectos de estos tratamientos antivirales en la mortalidad hospitalaria. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the effects of these antiviral treatments on the length of the hospital stay and on the reception of ventilation or intensive care. |
Los objetivos secundarios son evaluar los efectos de estos tratamientos antivirales en la duración de la estancia hospitalaria y en la recepción de ventilación o cuidados intensivos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• That you agree to participate in the study by signing the informed consent. • Men and women aged ≥18 years • Patients admitted with a diagnosis of severe pneumonia due to SARS-CoV-2. • Diagnosis of SARS-CoV-2 infection confirmed by PCR carried out ≤ 4 days prior to randomization. • Onset of symptoms ≤ 4 days. • Basal oxygen saturation ≤ 93%. • Men and women with reproductive capacity should agree to use highly effective contraceptive methods (diaphragm plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence, or vasectomy) during your participation in the study and within 30 days of the last visit. • In addition, women participating in the study with reproductive ability must have a negative pregnancy test at enrollment. |
• Que acepte participar en el estudio firmando el consentimiento informado. • Hombre y mujeres con edad ≥18 años • Pacientes ingresados con diagnóstico de neumonía grave por SARS-CoV-2. • Diagnóstico de infección por SARS-CoV-2 confirmado por PCR realizado ≤ 4 días previo a la aleatorización. • Inicio de los síntomas ≤ 4 días. • Saturación de oxígeno basal ≤ 93%. • Los hombres y mujeres con capacidad reproductiva deben acceder a usar métodos anticonceptivos altamente eficaces (diafragma más espermicida o preservativo masculino más espermicida, anticonceptivo oral combinado con un segundo método de implante anticonceptivo, anticonceptivo inyectable, dispositivo intrauterino permanente, abstinencia sexual o vasectomía) durante su participación en el estudio y en los 30 días siguientes a la última visita. • Además, las mujeres participantes en el estudio con capacidad reproductiva deben tener una prueba de embarazo negativa en el momento de la inclusión. |
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E.4 | Principal exclusion criteria |
• Patients participating in some other clinical trial for SARS-CoV-2 infection. • Concomitant treatment with other drugs than the treatments included in this study with demonstrated or potential action against SARS-CoV-2 in the 24 hours prior to the administration of the study treatment. • They already receive some of the study drugs. • Evidence of multi-organ failure. • Patients who require mechanical ventilation at the time of inclusion. • Patients who present criteria for acute respiratory distress at the time of inclusion. • ALT or AST> 5 times the upper limit of normal during screening. • Creatinine clearance <50 ml / min during screening. • Pregnancy test with positive result during screening. • Lactating women. • Patients with known hypersensitivity or contraindication to any of the drugs in the study treatment arms, their metabolites or excipients. • Patients who for any reason should not be included in the study according to the evaluation of the research team. • Subjects who are unable to understand the information sheet and unable to sign the informed consent. • Patients who are expected to transfer to another center in the next 96 hours. |
• Pacientes participando en algún otro ensayo clínico para infección por SARS-CoV-2. • Tratamiento concomitante con otros fármacos diferentes a los tratamientos incluidos en este estudio con acción demostrada o potencial frente a SARS-CoV-2 en las 24 horas previas a la administración del tratamiento del estudio. • Reciben ya alguno de los medicamentos del estudio. • Evidencia de fallo multiorgánico. • Pacientes que requieren ventilación mecánica en el momento de inclusión. • Pacientes que presenten criterios de distrés respiratorio agudo en el momento de inclusión. • ALT o AST >5 veces el límte superior de la normalidad durante el screening. • Aclaramiento de creatinina < a 50 ml/min durante el screening. • Test de embarazo con resultado positivo durante el screening. • Mujeres en periodo de lactancia. • Pacientes con hipersensibilidad conocida o contraindicación a alguno de los fármacos de las ramas de tratamiento del estudio, sus metabolitos o excipientes. • Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación del equipo investigador. • Sujetos que no sean capaces de comprender la hoja de información e incapaces de firmar el consentimiento informado. • Pacientes a los que se prevea su traslado a otro centro en las siguientes 96 horas. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Discharge from the patient or death |
Alta hospitalaria o fallecimiento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The main result is all-cause mortality, subdivided by disease severity at the time of randomization. |
El resultado principal es la mortalidad por todas las causas, subdividida por la gravedad de la enfermedad en el momento de la aleatorización. |
|
E.5.2 | Secondary end point(s) |
The main secondary outcomes are the length of hospital stay and whether the patient received assisted ventilation (or intensive care). |
Los principales resultados secundarios son la duración de la estancia hospitalaria y el si el paciente recibió ventilación asistida (o cuidados intensivos). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Discharge from the patient or death |
Alta hospitalaria o fallecimiento |
|
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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 8 |
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
|
LVLS |
Ultima visita del ultimo paciente |
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |