E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID. |
Pacientes que alcancen un grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID. |
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E.2.2 | Secondary objectives of the trial |
- Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.
- Length of stay in ICU of those patients who finally require it
- Length of hospital stay
- Describe the safety profile of the study combination after 7 and 14 days of treatment.
- Describe the percentage of patients alive at 6 and 12 months of the patients under study.
- Describe the percentage of patients who died from any cause 28 days after inclusion in the study. |
Porcentaje de pacientes que desarrollan insuficiencia respiratoria grave (grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID) en los primeros14 días de participación en este estudio.
- Duración de estancia en UCI de aquellos pacientes que finalmente lo requieran
- Duración de la estancia hospitalaria
- Describir el perfil de seguridad de la combinación en estudio tras 7 y 14 días de tratamiento
- Describir porcentaje de pacientes vivos a 6 y 12 meses de los pacientes en estudio
- Describir el porcentaje de pacientes fallecidos, por cualquier causa, a los 28 días de la inclusión en el presente estudio |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who have given their written informed consent. If it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the SARS-Cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history.
- Clinical diagnosis or confirmed by analytical tests (PCR of viral RNA or detection of antiSARS-Cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the WHO 7-point ordinal scale of severity categorization for COVID.
- Platelets> 50,000 / uL, neutrophils> 500 / ul
- Kidney or liver failure is not a contraindication, dose adjustment will be made according to the SmPC
- Women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception:
* Negative serum or urine pregnancy test in the 72 hours prior to the start of treatment.
*Use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment |
- Pacientes que hayan otorgado su consentimiento informado por escrito. En caso de considerarse que la obtención de consentimiento escrito podría constituir un factor de trasmisión de la enfermedad (dada la alta contagiosidad del virus SARS-Cov-2) se permitirá la obtención de consentimiento verbal debidamente justificado en la historia clínica del paciente.
- Diagnóstico clínico o confirmado mediante tests analíticos (PCR de RNA viral o detección de anticuerpos antiSARS-Cov-2) que requiera atención en régimen hospitalario y que se encuentren en los grados 3 o 4 de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID
- Plaquetas>50.000/uL, neutrófilos> 500/ul
- La insuficiencia renal o hepática no es una contraindicación, se realizará ajuste de dosis según ficha técnica
- Las mujeres en edad fértil sexualmente activas, no sometidas a histerectomía o doble anexectomía, deben seguir las siguientes indicaciones sobre contracepción:
*Prueba del embarazo en suero u orina negativa en las 72 horas anteriores al inicio del tratamiento.
*Utilización de un método anticonceptivo médicamente aceptado durante: los 2 meses anteriores al inicio del tratamiento del estudio, durante el estudio y hasta 3 meses después de la última dosis del tratamiento |
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E.4 | Principal exclusion criteria |
- Documented concomitant severe bacterial or fungal infection
- Infection with HIV, HCV, HBV
- Age <18 years
- Thrombocytopenia <50,000 / uL, Neutropenia <500 / uL
- Women of childbearing age who do not use an effective contraceptive method.
- Pregnant or lactating women.
- Patients who do not want or cannot comply with the protocol.
- Patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small intestine or inability to swallow oral medication. Previous partial or total gastrectomy is not an exclusion criterion |
- Documentación de infección bacteriana o fúngica grave concomitante
- Infección por VIH, VHC, VHB
- Edad<18 años
- Trombopenia <50.000/uL, neutropenia<500/uL
- Mujeres en edad fértil que no empleen un método anticonceptivo efectivo.
- Mujeres embarazadas o en lactancia.
- Pacientes que no quieran o no puedan cumplir con el protocolo.
- Pacientes con alteración de la función gastrointestinal o con enfermedad gástrica que altere significativamente la absorción de ruxolitinib o simvastatina, como por ejemplo: enfermedades ulcerosas graves, náuseas descontroladas, vómitos, diarrea, síndrome de malabsorción, resección extensa (>1m) del intestino delgado o incapacidad para tragar medicación oral. La gastrectomía previa parcial o total no es un criterio de exclusión |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID. |
Pacientes que alcancen un grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID. |
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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) |
- Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.
- Length of stay in ICU of those patients who finally require it
- Length of hospital stay
- Describe the safety profile of the study combination after 7 and 14 days of treatment.
- Describe the percentage of patients alive at 6 and 12 months of the patients under study.
- Describe the percentage of patients alive at 6 and 12 months of the patients under study. |
Porcentaje de pacientes que desarrollan insuficiencia respiratoria grave (grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID) en los primeros 14 días de participación en este estudio.
- Duración de estancia en UCI de aquellos pacientes que finalmente lo requieran
- Duración de la estancia hospitalaria
- Describir el perfil de seguridad de la combinación en estudio tras 7 y 14 días de tratamiento
- Describir porcentaje de pacientes vivos a 6 y 12 meses de los pacientes en estudio
- Describir el porcentaje de pacientes fallecidos, por cualquier causa, a los 28 días de la inclusión en el presente estudio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 14 days
- 28 days
- 28 days
- 7 & 14 days
- 6 & 12 months
- 28 days |
- 14 días
- 28 días
- 28 días
- 7 & 14 días
- 6 & 12 meses
- 28 días |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
El tratamiento habitual para esa enfermedad. |
Usual treatment for this condition |
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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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Last patient last visit |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |