E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 2019 (COVID-19) |
Enfermedad por el Coronavirus 2019 (COVID-19) |
|
E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease 2019 (COVID-19) |
Enfermedad por el Coronavirus 2019 (COVID-19) |
|
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 |
|
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 provide expanded access of RDV for the treatment of SARS-CoV2 infection |
Proporcionar acceso expandido de RDV para el tratamiento de la infección SARS-CoV2 |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety of RDV with respect to incidence of treatment emergent adverse events |
Evaluar la seguridad de RDV con respecto a la incidencia de eventos adversos emergentes en el tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age) 2) Age ≥ 18 years 3) Hospitalized with confirmed SARS-CoV2 by PCR or known contact of confirmed case with syndrome consistent with COVID-19 with PCR pending 4) Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy) 5) Adequate renal function with estimated glomerular filtration rate ≥ 30 ml/min by local laboratory measure 6) ALT ≤ 5 x upper limit of normal (ULN) by local laboratory measure |
Los sujetos deben cumplir todos los siguientes criterios de inclusión para ser elegibles para la participación en este estudio: 1) Disposición y capacidad para otorgar el consentimiento informado por escrito, o disponibilidad de un representante legal que pueda otorgar el consentimiento informado, o inclusión al amparo de las disposiciones relativas al uso en situaciones de urgencia de la norma ICH E6(R2) 4.8.15, según lo considere necesario el investigador (participantes de ≥18 años) 2) Edad ≥ 18 años 3) Hospitalizado con SARS-CoV2 confirmado por PCR o contacto conocido de caso confirmado con síndrome consistente con COVID-19 con PCR pendiente 4) Requiera ventilación mecánica invasiva (por ejemplo, por vía endotraqueal intubación o traqueotomía) 5) Función renal adecuada con una tasa estimada de filtración glomerular ≥ 30 ml/min por medida de laboratorio local 6) ALT ≤ 5 x límite superior de normalidad (LSN) por medida de laboratorio local |
|
E.4 | Principal exclusion criteria |
1) Evidence of multiorgan failure 2) Pressor requirement to maintain blood pressure 3) Renal failure (eGRF < 30 mL/min or dialysis or continuous Veno-Venous Hemofiltration 4) Pregnancy |
1) Evidencia de fallo multiorgánico 2) Requerimiento de presor para mantener la presión sanguínea 3) Fallo renal (eGRF < 30 mL/min. o diálisis o Veno-Hemofiltración venosa continua 4) Embarazo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The incidence rate of treatment-emergent adverse events |
La tasa de incidencia de eventos adversos emergentes en el tratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not Applicable |
No Aplicable |
|
E.5.2 | Secondary end point(s) |
Not Applicable |
No Aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not Applicable |
No Aplicable |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Protocolo de Acceso Expandido |
Expanded Access Treatment Protocol |
|
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 | No |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
France |
Germany |
Italy |
Spain |
Switzerland |
United Kingdom |
|
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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |