E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe COVID-19 Disease |
Enfermedad por COVID-19 de moderada a severa |
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E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe COVID-19 Disease |
Enfermedad por COVID-19 de moderada a severa |
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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 | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory 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 |
To estimate the efficacy of Asunercept in the treatment of hospitalized patients with moderate to severe COVID-19 when given as add on to Standard of Care |
Determinar la eficacia de asunercept en el tratamiento de pacientes hospitalizados con COVID-19 moderada o grave cuando se administra como complemento del tratamiento de referencia. |
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E.2.2 | Secondary objectives of the trial |
To estimate the efficacy of Asunercept when given as add on to Standard of Care in reducing progression to more severe disease (i.e., invasive mechanical ventilation) or death |
Determinar la eficacia de asunercept cuando se administra como complemento del tratamiento de referencia para reducir la progresión a una enfermedad más grave (ventilación mecánica invasiva) o la muerte. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol 2. The patient is a male or female adult aged ≥18 years at the time of giving informed consent 3. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test 4. The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19 5. The patient agrees to not participate in another clinical trial from screening until d56 6. The patient is willing to follow effective measures of contraception during the trial |
1. El paciente debe estar dispuesto y ser capaz de otorgar su consentimiento informado para participar en el ensayo y cumplir los procedimientos indicados en el protocolo. 2. El paciente es un varón o una mujer adulto de al menos 18 años en el momento de otorgar el consentimiento informado. 3. El paciente ingresa en un hospital (como máximo de 72 horas antes de la aleatorización) debido a la COVID-19 y da positivo en una prueba de reacción en cadena de la polimerasa (PCR) del SARS-CoV-2. 4. El paciente presenta síntomas clínicos indicativos de enfermedad moderada o grave (correspondientes a una puntuación de 5 [oxígeno con mascarilla o cánula nasal] o 6 [oxígeno mediante ventilación no invasiva o caudal elevado] en la escala de progresión clínica de 10 puntos de la OMS) con COVID-19 antes del tratamiento del ensayo el día 1: neumonía por COVID-19 confirmada radiológicamente o signos clínicos indicativos de enfermedad moderada o grave por COVID-19. 5. El paciente acepta no participar en otro ensayo clínico desde la selección hasta el día 56. 6. El paciente está dispuesto a utilizar métodos anticonceptivos eficaces durante el ensayo. |
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E.4 | Principal exclusion criteria |
1. The patient is moribund or has an estimated life expectancy <1 month 2. The patient is pregnant or breastfeeding 3. The patient is anticipated to be discharged from hospital within 48 hrs 4. The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) 5. The patient requires invasive mechanical ventilation 6. The patient is known to have active tuberculosis 7. The patient is known to have hereditary fructose intolerance 8. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections |
1. El paciente está moribundo o tiene una esperanza de vida estimada <1 mes (p. ej., cáncer terminal, etc.). 2. La paciente está embarazada o amamantando. 3. Se prevé que el paciente reciba el alta hospitalaria en un plazo de 48 horas. 4. El paciente necesita antiinflamatorios que no forman parte del tratamiento de referencia (se entiende por tratamiento de referencia los fármacos aprobados para el tratamiento de la COVID-19). Además, el tratamiento de referencia incluye medicamentos recomendados en las directrices terapéuticas de las autoridades sanitarias nacionales o de una organización profesional). 5. El paciente requiere ventilación mecánica invasiva. 6. Se sabe que el paciente tiene tuberculosis activa. 7. Se sabe que el paciente presenta intolerancia hereditaria a la fructosa. 8. Se sabe que el paciente presenta coinfección por virus de la gripe u otras infecciones respiratorias víricas (virus respiratorio sincitial [VRS], virus parainfluenza, adenovirus respiratorios). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to sustained recovery, defined as sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10-point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first |
Tiempo transcurrido hasta la recuperación mantenida, definida como una mejoría mantenida (sin disminución) ≥2 puntos en la escala de progresión clínica de 10 puntos de la OMS o el alta hospitalaria seguida de estar vivo y en casa durante 14 días consecutivos antes del día (d) 56, lo que ocurra antes. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 to 28, 35, 42, 49 & 56 |
Día 1 al 28, 35, 42, 49 & 56 |
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E.5.2 | Secondary end point(s) |
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28 |
Mortalidad global o progresión a ventilación mecánica invasiva (VMI) el día 28. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | 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 | 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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
India |
South Africa |
Austria |
France |
Poland |
Spain |
Germany |
Italy |
Georgia |
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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
|
the date of the last visit (Follow-up phone call) of the last patient in the trial |
Fecha de la última visita (llamada telefónica de seguimiento) al último paciente del ensayo |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | 20 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 20 |