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Trial - EUCTR2021-003331-28-ES


Column Value
Trial registration number EUCTR2021-003331-28-ES
Full text link
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003331-28/ES

First author
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

FISABIO - Área de Ensayos Clínicos

Contact
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

rodenas_van@gva.es

Registration date
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

2021-06-21

Recruitment status
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Long covid

Inclusion criteria
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Adults (≥18 years) admitted for COVID-19 who continue with moderate or severe symptoms collected in the “COVID-19 Symptom Questionnaire” three months after hospital discharge and who sign the informed consent Personas adultas (≥18 años) ingresadas por COVID-19 que continúan con síntomas moderados o intensos recogidos en el “Cuestionario de síntomas COVID-19” tres meses después del alta hospitalaria y que firmen el consentimiento informado.

Exclusion criteria
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

-Patients who have received any dose of any of the COVID-19 vaccines. -Contraindication for the COMIRNATY vaccine according to the technical data sheet. -Women who are pregnant or intend to become pregnant during the next three months after the administration of the vaccine. -Pacientes que hayan recibido alguna dosis de cualquiera de las vacunas contra la COVID-19. -Contraindicación para la vacuna COMIRNATY según ficha técnica. -Mujeres embarazadas o que pretendan quedarse embarazadas durante los siguientes tres meses tras la administración de la vacuna.

Number of arms
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Felix Gutierrez Rodero

Inclusion age min
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

65

Countries
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Spain

Type of patients
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Patients recovered from covid

Severity scale
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

776

primary outcome
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Change in the global score of the “COVID-19 Symptom Questionnaire” at week 12 after the administration of the second dose of COMIRNATY vaccine Cambio en la puntuación global del “Cuestionario de síntomas COVID-19” a la semana 12 de la administración de la segunda dosis de la vacuna COMIRNATY.

Notes
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

nan

Phase
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : Aug. 3, 2021, 5:30 p.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]