E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 infection |
Infección por COVID-19 |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 infection |
Infección por COVID-19 |
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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 | PT |
E.1.2 | Classification code | 10084460 |
E.1.2 | Term | COVID-19 treatment |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 evaluate the clinical efficacy of TF0023 relative to the control arm in patients hospitalized with respiratory impairment from acute COVID-19 as assessed by the ability to maintain peripheral capillary oxygen saturation (SpO2) of >93% without supplemental oxygen. |
Evaluar la eficacia clínica de TF0023 frente al grupo de control en pacientes hospitalizados con insuficiencia respiratoria por COVID-19 aguda, en su determinación por la capacidad de mantener la saturación capilar periférica de oxígeno (SpO2) >93% sin oxigenoterapia. |
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E.2.2 | Secondary objectives of the trial |
1: To evaluate the safety of TF0023 compared to placebo. 2: To evaluate the clinical effect of TF0023 as compared to placebo, as assessed by time to not require supplemental oxygen. 3: To evaluate the clinical efficacy of TF0023 as compared to placebo, as assessed by clinical status (9-point ordinal scale) at Day 15. |
. Evaluar la seguridad de TF0023 en comparación con placebo. 2. Evaluar el efecto clínico de TF0023 en comparación con placebo, a juzgar por el tiempo hasta dejar de precisar oxigenoterapia. 3. Evaluar la eficacia clínica de TF0023 en comparación con placebo, a juzgar por el estado clínico (escala ordinal de 9 puntos) el día 15. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PK sub-study: Blood samples will be collected during the study to assess the PK of TF0023, TF0039, salicylic acid, and aspirin in the COVID-19 population. Blood samples will be collected from up to 100 patients at select sites with expertise in PK sampling. |
Subestudio de PK: Se recogerán muestras de sangre durante el estudio para evaluar la farmacocinética de TF0023, TF0039, ácido salicílico y aspirina en la población con COVID-19. Se recogerán muestras de sangre de hasta 100 pacientes en los centros seleccionados con experiencia en muestreo PK. |
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E.3 | Principal inclusion criteria |
- Admitted to a hospital with pulmonary symptoms of active COVID-19. - Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures and agrees to comply with planned study procedures. - Male or nonpregnant female adult ≥18 years of age at time of enrollment. - Has laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (serology is not acceptable) |
-Hospitalizado por síntomas pulmonares de COVID-19 activa. -El paciente (o su representante legal) otorga su consentimiento informado antes de iniciar ningún procedimiento del estudio y acepta cumplir con los procedimientos del estudio previstos. 4. Varón o mujer no embarazada, adulto >/=18 años de edad en el momento de la inclusión. 5. Presenta infección por el coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2), confirmada en el laboratorio mediante reacción en cadena de la polimerasa (polymerase chain reaction, PCR) u otro método comercial o de salud pública (no es aceptable la serología) |
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E.4 | Principal exclusion criteria |
- Any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study - Extracorporeal membrane oxygenation required at baseline. - Anticipated discharge from the hospital or transfer to another hospital which is not a study site. |
-Todo trastorno, lo que comprende cualquier proceso médico o neuropsiquiátrico significativo, incluida la presencia de anomalías de laboratorio, que suponga para el paciente un riesgo inaceptable si participase en el estudio o dificulte la interpretación de los datos del estudio, a juicio del investigador. -Necesidad de oxigenación por membrana extracorpórea en el momento basal. -Previsión de alta del hospital o traslado a otro hospital no participante en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15. |
Porcentaje de pacientes capaces de mantener la saturación capilar periférica de oxígeno (SpO2) >93% sin oxigenoterapia el día 15. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Time to not requiring oxygen support. - Cumulative incidence of SAEs - Cumulative incidence of Grade 3 and 4 clinical and/or laboratory AEs |
-Tiempo hasta dejar de precisar oxigenoterapia -Incidencia acumulada de SAE -Incidencia acumulada de AE clínicos y/o de laboratorio de grados 3 y 4 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From Day 1 to Day 29 |
Desde el día 1 hasta el día 29 |
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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 | 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) | 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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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 |
South Africa |
United States |
France |
Bulgaria |
Romania |
Spain |
Ukraine |
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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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LPLV |
Último paciente, última visita |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 25 |
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 |