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] - Respiratory Tract Diseases [C08] |
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 |
Assessing the safety and efficacy of MSV-allo® in obtaining recovery from respiratory failure in patients with pneumonia due to severe / critical COVID-19 infection. |
Evaluar la seguridad y eficacia de MSV-allo® en obtener la recuperación del fallo respiratorio de los pacientes con neumonía por infección COVID-19 severo/crítico. |
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E.2.2 | Secondary objectives of the trial |
1. Time to recover from the symptoms and clinical signs after the MSV-allo® administration 2. Time to reach the normalization of imaging tests, chest radiography and/or lung CT 3. Modification in the inflammatory response in terms of blood levels of cytokines and chemokines. 4. Modification in the number of leukocytes and lymphocyte populations. 5. Safety, tolerability and immunogenicity profiles of MSV-allo® in patients with severe COVID-19 |
1. Tiempo que se tarda en alcanzar la recuperación de los síntomas y signos clínicos tras el trasplante de MSV-allo®. 2. Tiempo que se tarda en alcanzar la normalización de las pruebas de imagen, radiografía de tórax y/o TAC pulmonar 3. Modificación en la respuesta inflamatoria en cuanto a nivel de citocinas y quimiocinas en sangre. 4. Modificación en el recuento de leucocitos y poblaciones linfocitarias. 5. Perfiles de seguridad, tolerabilidad e inmunogenicidad de las MSV-allo® en los pacientes con COVID-19 severo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women or men of equal or more than 18 years of age 2. SARS-CoV-2 infection confirmed by molecular testing. 3. Admitted to the Intensive Care Unit with pneumonia secondary to COVID-19 infection in the last 48 hours, who meet at least one of these criteria: to. Respiratory distress. yes. Respiratory rate (RR) equal or more than 30 rpm. C. Basal oxygen saturation at rest equal or less than 93%. re. Arterial partial pressure of oxygen (PaO2) / inspiratory fraction of oxygen (FiO2) equal or less than 300 mmHg. 4. Compliance of the patient or his legal representative for participation in the study. |
1. Mujeres o varones de edad superior o igual a 18 años. 2. Infección por SARS-CoV-2 confirmada mediante prueba molecular. 3. Ingresados en la Unidad de Cuidados Intensivos con neumonía secundaria a infección por COVID-19 en las últimas 48 horas, que cumplan al menos uno de estos criterios: a. Distrés respiratorio. b. Frecuencia respiratoria (FR) mayor o igual a 30 rpm. c. Saturación de oxígeno basal en reposo menor o igual a 93%. d. Presión parcial arterial de oxígeno (PaO2)/fracción inspiratoria de oxígeno (FiO2) menor o igual a 300mmHg. 4. Conformidad del paciente o su representante legal para la participación en el estudio. |
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E.4 | Principal exclusion criteria |
1. Active tumor disease. 2. Pregnancy. 3. Participation in another active clinical trial. 4. Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial. 5. Not consent to participation. |
1. Padecer una enfermedad tumoral activa. 2. Embarazo. 3. Participación en otro ensayo clínico activo. 4. Cualquier circunstancia que en opinión del investigador justifique la no participación del paciente en el ensayo. 5. No prestar consentimiento para la participación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Proportion of patients in whom removal of invasive mechanical ventilation has been achieved in less than 7 days after IMP administration. 2. Proportion of patients surviving on day 28 from diagnosis |
1. Proporción de pacientes en que se ha conseguido la retirada de la ventilación mecánica invasiva en menos de 7 días tras la administración del PEI. 2. Proporción de pacientes que sobreviven el día 28 desde el diagnóstico |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7 days from treatment and 28 days from diagnosis |
7 días desde el tratamiento y 28 días desde el diagnóstico |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients who have achieved a complete clinical response, with disappearance of the symptoms of the disease. 2. Proportion of patients who have achieved a complete radiological response 3. Proportion of patients who did not require immunosuppressive treatment after treatment. |
1. Proporción de pacientes que han alcanzado la respuesta clínica completa, con desaparición de los síntomas propios de la enfermedad. 2. Proporción de pacientes que han alcanzado respuesta radiológica completa 3. Proporción de pacientes que no han necesitado tratamiento inmunosupresor tras el tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Periodically during hospitalization |
Periódicamente durante hospitalización |
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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 | 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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |