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    Summary
    EudraCT Number:2021-003331-28
    Sponsor's Protocol Code Number:LONGCOV-VAC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-003331-28
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the COMIRNATY vaccine (COVID-19 mRNA vaccine, Pfizer-BioNTech) in people with long COVID
    Ensayo clínico aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de la vacuna COMIRNATY (vacuna COVID-19 ARNm, Pfizer-BioNTech) en personas con COVID persistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to analyze whether the administration of a vaccine against COVID19 infection can reduce the symptoms of long COVID.
    El objetivo del estudio es analizar si la administración de una vacuna contra la infección COVID19 puede hacer disminuir los síntomas de COVID persistente.
    A.4.1Sponsor's protocol code numberLONGCOV-VAC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFelix Gutierrez Rodero
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFISABIO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISABIO
    B.5.2Functional name of contact pointÁrea de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressAvda de Cataluña, n 21
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46020
    B.5.3.4CountrySpain
    B.5.6E-mailrodenas_van@gva.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer-BioNTech
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unlike what happens with other respiratory viruses, in a significant proportion of patients who have suffered from the disease, general and multi-organ symptoms may persist for months, which has been called long COVID
    A diferencia de lo que ocurre con otros virus respiratorios, en una proporción significativa de los pacientes que han sufrido la enfermedad pueden persistir síntomas generales y multiorgánicos durante meses, lo que se ha denominado COVID prolongado o persistente
    E.1.1.1Medical condition in easily understood language
    Some symptoms of COVID19 can continue for months after the acute phase of the infection.
    Algunos síntomas de la COVID19 pueden continuar meses después de haber superado la fase aguda de la infección.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of symptoms that persist three months after the acute phase of COVID.
    Evaluar el efecto de la vacuna COMIRNATY sobre la frecuencia e intensidad de la sintomatología que persiste tres meses después de la fase aguda de la COVID.
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of the different general and organic symptoms that persist three months after the acute phase of COVID.
    -To evaluate the effect of the COMIRNATY vaccine on the quality of life of people with long COVID.
    -To evaluate the safety of the COMIRNATY vaccine in people with long COVID.
    -Evaluar el efecto de la vacuna COMIRNATY sobre la frecuencia e intensidad de los diferentes síntomas generales y orgánicos que persisten tres meses después de la fase aguda de la COVID.
    -Evaluar el efecto de la vacuna COMIRNATY sobre la calidad de vida de las personas con COVID persistente.
    -Evaluar la seguridad de la vacuna COMIRNATY en personas con COVID persistente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    E.4Principal exclusion criteria
    -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.
    E.5 End points
    E.5.1Primary end point(s)
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be analyzed 12 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.
    El end point primario se determinará 12 semanas después de la administración de la segunda dosis de la vacuna que se administra 21 (+/-2) días después de la primera dosis.
    E.5.2Secondary end point(s)
    -Change in the global score of the “COVID-19 Symptom Questionnaire” at week 24 and 48 after the administration of the second dose of COMIRNATY vaccine.
    -Change in the score of each one of the “symptomatic areas” of the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine: general, respiratory / thoracic symptoms, digestive, otorhinolaryngological and neuropsychiatric.
    -Change in the score of each of the symptoms in the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine.
    -Change in the score on the anxiety, depression and quality of sleep scales at week 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine.
    -Change in the score in the WHOQOL-Bref quality of life questionnaire at weeks 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine.
    -Proportion of symptoms that improve, do not change, or worsen at weeks 12, 24, and 48 after the second dose of COMIRNATY vaccine is administered.
    -Proportion of patients who develop clinical and laboratory adverse events at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine.
    -Cambio en la puntuación global del “Cuestionario de síntomas COVID-19” a la semana 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    -Cambio en la puntuación de cada una de las “esferas sintomáticas” del “Cuestionario de síntomas COVID-19” a las semanas 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY: síntomas generales, respiratorios/torácicos, digestivos, otorrinolaringológicos y neuropsiquiátricos.
    -Cambio en la puntuación de cada uno de los síntomas en el “Cuestionario de síntomas COVID-19” a las semanas 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    -Cambio en la puntuación en las escalas de ansiedad, depresión y calidad del sueño a la semana 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    -Cambio en la puntuación en el cuestionario de calidad de vida WHOQOL-Bref a la semana 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    -Proporción de los síntomas que mejoran, no cambian o empeoran a la semana 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    -Proporción de pacientes que desarrollan acontecimientos adversos clínicos y de laboratorio a la semana 12, 24 y 48 de la administración de la segunda dosis de la vacuna COMIRNATY.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will be analyzed 12, 24 or 48 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.
    Los end point secundarios se determinarán 12, 24 o 48 semanas después de la administración de la segunda dosis de la vacuna que se administra 21 (+/-2) días después de la primera dosis.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 776
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state776
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue to receive necessary clinical care for at least 12 months after completion of the study.
    Los paciente seguirán recibiendo la atención clínica necesaria durante al menos 12 meses tras su finalización en el estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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