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 | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to the time to discharge |
Evaluar la eficacia de 2 pautas de remdesivir (RDV) en comparación con el tratamiento de referencia (SOC), con respecto al tiempo del alta |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of RDV compared to SOC |
Evaluar la seguridad y la tolerabilidad de RDV en comparación con el tratamiento de referencia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Willing and able to provide written informed consent prior to performing study procedures 2) Aged ≥ 18 years 3) SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization 4) Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, ≥ 37.8 °C rectal 5) SpO2 > 94% on room air at screening 6) Radiographic evidence of pulmonary infiltrates 7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3. |
1) Disposición y capacidad para otorgar el consentimiento informado por escrito antes de realizar los procedimientos del estudio 2) Edad ≥ 18 años 3) Infección por el SARS-CoV-2 confirmada mediante PCR ≤ 4 días antes de la aleatorización 4) Hospitalización con fiebre, definida como una temperatura ≥ 36,6 °C en la axila, ≥ 37,2 °C en la boca y ≥ 37,8 °C en el recto 5) SpO2 > 94% con aire ambiente en la fase de selección 6) Signos radiológicos de infiltrados pulmonares 7) Los varones y las mujeres con capacidad de procrear que mantengan relaciones heterosexuales deben comprometerse a utilizar métodos anticonceptivos especificados en el protocolo, tal como se describe en el Apéndice 3. |
|
E.4 | Principal exclusion criteria |
1) Participation in any other clinical trial of an experimental agent treatment for COVID-19 2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing 3) Requiring mechanical ventilation at screening 4) ALT or AST > 5 x ULN 5) Creatinine clearance < 50 mL/min 6) Positive pregnancy test (Protocol Appendix 3) 7) Breastfeeding woman 8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient |
1) Participar en cualquier otro ensayo clínico de tratamiento con un fármaco experimental contra el COVID-19 2) Queda prohibido el tratamiento concomitante con otros fármacos con actividad antiviral directa real o posible contra el SARS-CoV-2 en las 24 horas previas a la administración del fármaco del estudio. 3) Necesidad de ventilación mecánica en la fase de selección 4) ALT or AST > 5 x LSN 5) Aclaramiento de creatinina < 50 mL/min 6) Prueba de embarazo positiva (protocolo, apendix 3) 7) Mujeres lactantes 8) Hipersensibilidad conocida al fármaco del estudio, sus metabolitos o los excipientes de la formulación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants discharged by Day 14 |
La proporción de participantes dados de alta el día 14 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
Desde el inicio de la medicación del estudio hasta el día 14 |
|
E.5.2 | Secondary end point(s) |
The proportion of participants with treatment emergent adverse events leading to study drug discontinuation |
La proporción de participantes con efectos adversos emergentes en el tratamiento que llevan a la interrupción del fármaco de estudio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
Desde el inicio de la medicación del estudio hasta el día 14 |
|
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
China |
France |
Germany |
Hong Kong |
Italy |
Japan |
Korea, Republic of |
Singapore |
Spain |
Taiwan |
United States |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |