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    Summary
    EudraCT Number:2021-002895-38
    Sponsor's Protocol Code Number:C4671005
    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:2021-07-20
    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 number2021-002895-38
    A.3Full title of the trial
    AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
    ESTUDIO INTERVENCIONAL DE FASE II/III, DOBLE CIEGO, DE DOS GRUPOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE PF-07321332/RITONAVIR ADMINISTRADOS ORALMENTE Y COMPARADO CON PLACEBO EN PACIENTES ADULTOS SINTOMÁTICOS NO HOSPITALIZADOS CON COVID-19 QUE TENGAN RIESGO ELEVADO DE PROGRESAR A ENFERMEDAD SEVERA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2/3 Efficacy And Safety Study Of PF-07321332/Ritonavir in Nonhospitalized High Risk Adult Participants With COVID 19
    Estudio de eficacia y seguridad de fase II/III de PF-07321332/ritonavir en participantes adultos de alto riesgo no hospitalizados con COVID-19
    A.4.1Sponsor's protocol code numberC4671005
    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 SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 RITONAVIR
    D.2.1.1.2Name of the Marketing Authorisation holderCamber Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.1Product nameRitonavir
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    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 No
    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.3.1Product namePF-07321332
    D.3.2Product code PF-07321332
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-07321332
    D.3.9.3Other descriptive namePF-07321332
    D.3.9.4EV Substance CodeSUB220919
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus Disease 2019 (COVID-19)
    Enfermedad de coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection disease
    Enfermedad infecciosa de coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of PF-07321332/ritonavir to placebo for the treatment of COVID-19 in nonhospitalized symptomatic adult participants with COVID-19 who are at increased risk of progression to severe disease.
    • Comparar la eficacia del PF-07321332/ritonavir con el placebo para el tratamiento de COVID-19 en participantes adultos sintomáticos no hospitalizados con COVID 19 con un mayor riesgo de progresión a enfermedad grave.
    E.2.2Secondary objectives of the trial
    -To describe the safety and tolerability of PF-07321332/ritonavir relative to placebo in the treatment of nonhospitalized symptomatic adult participants with COVID-19 who are at increased risk of progression to severe disease.
    -To compare PF-07321332/ritonavir to placebo for the duration and severity of signs and symptoms in nonhospitalized symptomatic adult participants with COVID-19 who are at increased risk of progression to severe disease.
    -To compare PF-07321332/ritonavir to placebo for all-cause mortality in nonhospitalized symptomatic adult participants with COVID-19 who are at increased risk of progression to severe disease.
    -To determine the PK of PF-07321332 in nonhospitalized symptomatic adult participants with COVID 19 who are at increased risk of progression to severe disease.
    *details of remaining objectives in Protocol
    - Describir la seguridad y tolerabilidad del PF-07321332/ritonavir en relación con el placebo en el tratamiento de participantes adultos sintomáticos no hospitalizados con COVID 19 con un mayor riesgo de progresión a enfermedad grave.
    -Comparar al PF-07321332/ritonavir con el placebo en cuanto a la duración y gravedad de los signos y síntomas en participantes adultos sintomáticos no hospitalizados con COVID-19 que estén en mayor riesgo de progresión a enfermedad grave.
    -Comparar el PF-07321332/ritonavir con el placebo para la mortalidad por todas las causas en participantes adultos sintomáticos no hospitalizados con COVID-19 con un mayor riesgo de progresión a enfermedad grave.
    -Determinar la FC del PF-07321332 en participantes adultos sintomáticos no hospitalizados con COVID-19 con un mayor riesgo de progresión a enfermedad grave.
    *Los objetivos restantes se encuentran en el protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants ≥18 years of age (or the minimum country-specific age of consent if >18) at the time of the Screening Visit.
    - WOCBP may be enrolled.
    - All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
    2.Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization.
    Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening.
    3.Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria).
    4.Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including:
    - ≥60 years of age;
    - BMI >25;
    - Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;
    - Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications:
    o Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
    o Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry.
    o HIV infection with CD4 cell count <200 mm3 and a viral load less than 400 copies/mL
    - Chronic lung disease (if asthma, requires daily prescribed therapy);
    - Known diagnosis of hypertension;
    - CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass;
    - Type 1 or Type 2 diabetes mellitus;
    - CKD provided the participant does not meet Exclusion Criterion 5;
    - Sickle cell disease;
    - Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies);
    - Active cancer, other than localized skin cancer, including those requiring treatment as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period;
    - Medical-related technological dependence (eg, CPAP [not related to COVID-19]).
    5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    1. Participantes ≥18 años (o la edad mínima de consentimiento específica del país si el sujeto >18 años) en el momento de la visita de selección.
    • Es posible inscribir a mujeres en edad fértil.
    • Todos los participantes en edad fértil deben aceptar el uso de un método anticonceptivo de gran eficacia. Consulte el Apéndice 4 para informarse sobre los criterios de reproducción para participantes varones (Apartado 10.4.1) y mujeres (Apartado 10.4.2).
    2. Infección confirmada por el SARS-CoV-2 determinada por RT-PCR en cualquier muestra obtenida en los 5 días anteriores a la aleatorización.
    Nota: RT-PCR es el método preferido; sin embargo, dado que los enfoques para la confirmación de infección por el SARS-CoV-2 están cambiando, se permiten otras pruebas moleculares o de antígenos que detecten el ARN vírico o las proteínas. El resultado de la prueba debe estar disponible para confirmar la idoneidad. Los participantes pueden inscribirse en función de los resultados positivos de una prueba rápida de los antígenos del SARS-CoV-2 realizada en la selección.
    3. Aparición inicial de signos/síntomas atribuibles a COVID-19 en los 5 días anteriores al día de la aleatorización y al menos 1 de los signos/síntomas especificados atribuibles a COVID-19 presentes el día de la aleatorización (véase el Apéndice 9 para informarse sobre los criterios).
    4. Tiene al menos una característica o enfermedad subyacente asociada a un aumento del riesgo de presentar enfermedad grave a causa de la COVID-19, entre las que se incluyen las siguientes:
    • ≥60 años de edad;
    • IMC >25;
    • Fumador actual (fumador de cigarrillos durante los últimos 30 días) y antecedentes de haber fumado al menos 100 cigarrillos en toda su vida;
    • Enfermedad inmunodepresora (p. ej., trasplante de médula ósea u órganos o deficiencias inmunitarias primarias) o uso prolongado de inmunodepresores:
    o Ha recibido corticosteroides equivalentes a prednisona ≥20 mg al día durante al menos 14 días consecutivos durante los 30 días anteriores al ingreso en el estudio.
    o Ha recibido tratamiento con productos biológicos (p. ej., infliximab, ustekinumab), inmunomoduladores (p. ej., metotrexato, 6MP, azatioprina) o quimioterapia antineoplásica en los 90 días anteriores al ingreso en el estudio.
    o Infección por el VIH con recuento de células CD4 <200 mm3 y una concentración vírica menor de 400 copias/ml
    • Enfermedad pulmonar crónica (si es asma, requiere tratamiento diario prescrito);
    • Diagnóstico conocido de hipertensión;
    • Enfermedades cardiovasculares, definidas como antecedentes de cualquiera de los siguientes: infarto de miocardio, apoplejía, accidente isquémico transitorio (AIR), insuficiencia cardíaca, angina de pecho con nitroglicerina prescrita, injertos de revascularización coronaria, intervención coronaria percutánea, endarterectomía carotídea y derivación aórtica;
    • Diabetes mellitus de tipo 1 o tipo 2;
    • Insuficiencia renal crónica, siempre y cuando el participante no cumpla el criterio de exclusión 5;
    • Anemia de células falciformes;
    • Alteraciones del desarrollo neurológico (p. ej., parálisis cerebral, síndrome de Down) u otras afecciones que confieren complejidad médica (p. ej., síndromes genéticos o metabólicos y anomalías congénitas graves);
    • Cáncer activo, aparte del cáncer de piel localizado, incluidos los que requieren tratamiento, siempre y cuando el tratamiento no se incluya entre los medicamentos prohibidos que deben administrarse/seguir administrándose durante el periodo del ensayo;
    • Dependencia tecnológica médica (p. ej., CPAP [no relacionada con la COVID-19]).
    5. Participantes que estén dispuestos y puedan cumplir con todas las visitas programadas, el plan de tratamiento, los análisis, las consideraciones de estilo de vida y otros procedimientos del estudio.

    Consentimiento informado:
    6. Capaz de dar el consentimiento informado firmado, tal como se describe en el Apéndice 1, que incluye el cumplimiento de los requisitos y las restricciones que figuran en el DCI y en este protocolo.
    E.4Principal exclusion criteria
    1. History of hospitalization for the medical treatment of COVID-19.
    2. Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator (see Section 8.1.2.)
    3. Prior to current disease episode, any confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any specimen collection.
    4. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C, or acute liver failure.
    5. Receiving dialysis or have known moderate to severe renal impairment [ie, eGFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula]
    6. Known HIV infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment from known medical history within past 6 months of the screening visit) (Appendix 8).
    7. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
    8. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
    9. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.
    10. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    11. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of PF-07321332/ritonavir (See Appendix 8).
    12. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days prior to first dose of PF-07321332/ritonavir and during study treatment (see Appendix 8).
    13. Has received or is expected to receive convalescent COVID-19 plasma.
    14. Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit.
    15. Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 therapeutics, through the long-term follow-up visit.
    16. Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
    17. Known prior participation in this trial or other trial involving PF-07321332.
    18. Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
    - AST or ALT level ≥2.5 X ULN;
    - Total bilirubin ≥2 X ULN (≥3 X ULN for Gilbert’s syndrome);
    - Absolute neutrophil count <1000/mm3.
    - GFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula30
    Note: If the investigator suspects the participant may have any of the above laboratory values, confirmatory tests should be performed at screening to confirm eligibility before the first dose of study intervention. See Appendix 2 for more details.
    19. Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization.
    Note: for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, oxygen saturation should be measured while on their standard home oxygen supplementation.
    20. Females who are pregnant or breastfeeding.
    21. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    1. Antecedentes de hospitalización para el tratamiento médico de COVID-19.
    2. Necesidad actual de hospitalización o necesidad anticipada de hospitalización dentro de las 48 horas siguientes a la aleatorización, según la opinión clínica del investigador del centro (consulte el Apartado 8.1.2.).
    3. Antes del episodio de la enfermedad actual, cualquier infección por el SARS-CoV-2 confirmada, determinada mediante una prueba molecular (antígeno o ácido nucleico) de cualquier muestra obtenida.
    4. Antecedentes médicos conocidos de hepatopatía activa (aparte de la esteatosis hepática no alcohólica); se incluye infección crónica o activa por hepatitis B o C, cirrosis biliar primaria, clase Child-Pugh B o C, o insuficiencia hepática aguda.
    5. Recibir diálisis o tener insuficiencia renal de moderada a grave conocida (es decir, VFGe <45 ml/min/1,73 m2 en los 6 meses anteriores a la visita de selección, mediante la fórmula CKD-EPI basada en creatinina sérica).29
    6. Infección por el VIH conocida con una concentración vírica superior a 400 copias/ml o toma de medicamentos prohibidos para el tratamiento del VIH (a partir de los antecedentes médicos conocidos durante los últimos 6 meses posteriores a la visita de selección) (Apéndice 8).
    7. Infección sistémica activa concurrente sospechada o confirmada que no sea COVID-19 y que pueda interferir con la evaluación de la respuesta al tratamiento del estudio.
    8. Cualquier enfermedad concomitante que requiera hospitalización y/o cirugía dentro de los 7 días anteriores al ingreso en el estudio, o que se considere potencialmente mortal en los 30 días anteriores al ingreso en el estudio, según lo determinado por el investigador.
    9. Antecedentes de hipersensibilidad u otra contraindicación a cualquiera de los componentes del tratamiento del estudio, según lo determinado por el investigador.
    10. Otras enfermedades o afecciones psiquiátricas, incluidas las ideas y conductas de suicidio recientes (durante el último año) o activas, o anomalías de laboratorio que puedan aumentar el riesgo de participar en el estudio o, según la opinión del investigador, causar que el participante sea inadecuado para el estudio.
    11. Uso actual o previsto de cualquier medicamento o sustancia que dependa en gran medida del CYP3A4 para el aclaramiento y para los que puedan asociarse concentraciones plasmáticas elevadas con acontecimientos graves y/o potencialmente mortales durante el tratamiento y durante 4 días después de la última dosis de PF-07321332/ritonavir (véase el Apéndice 8).
    12. Está prohibido el uso concomitante de cualquier medicamento o sustancia que sea un potente inductor del CYP3A4 durante los 28 días anteriores a la primera dosis de PF-07321332/ritonavir y durante el tratamiento del estudio (véase el Apéndice 8).
    13. Ha recibido o se espera que reciba plasma de convaleciente de COVID-19.
    14. Ha recibido o está previsto que reciba cualquier dosis de una vacuna contra el SARS-CoV-2 antes de la visita del día 34.
    15. No está dispuesto a abstenerse de participar en otro estudio clínico intervencionista con un compuesto o producto sanitario en fase de investigación, incluidos los tratamientos contra la COVID-19, hasta la visita de seguimiento a largo plazo.
    16. Administración previa de cualquier vacuna o medicamento en fase de investigación dentro de los 30 días (o según lo determinen los requisitos locales) o 5 semividas antes de la primera dosis del tratamiento utilizado en este estudio (el periodo que sea más largo).
    17. Participación anterior conocida en este ensayo u otro ensayo relacionado con el PF-07321332.
    18. Antecedentes conocidos de cualquiera de las siguientes anomalías en los análisis clínicos (durante los últimos 6 meses posteriores a la visita de selección):
    • Nivel de AST o ALT ≥2,5 X LSN;
    • Bilirrubina total ≥2 X LSN (≥3 X LSN para el síndrome de Gilbert);
    • Recuento absoluto de neutrófilos <1000/mm3.
    • VFG <45 ml/min/1,73 m2 en los 6 meses siguientes a la visita de selección, utilizando la fórmula CKD-EPI basada en creatinina sérica29
    Nota: Si el investigador sospecha que el participante puede presentar cualquiera de los valores de laboratorio anteriores, se deben realizar pruebas de confirmación en la selección para corroborar la idoneidad antes de la primera dosis del tratamiento del estudio. Véase el Apéndice 2 para obtener más detalles.
    19. Saturación de oxígeno <92 % en el aire de la habitación obtenida en reposo dentro de las 24 horas anteriores a la aleatorización.
    Nota: En el caso de los posibles participantes que reciban con frecuencia oxigenoterapia crónica para una afección pulmonar subyacente, se debe medir la saturación de oxígeno mientras se esté administrando la oxigenoterapia habitual en el hogar.
    20. Mujeres embarazadas o en periodo de lactancia.
    21. Personal del centro de investigación o empleados de Pfizer directamente involucrados en la realización del estudio, personal del centro supervisado de otra manera por el investigador y sus respectivos familiares.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with COVID-19 related hospitalization or death from any cause through Day 28.
    Proporción de participantes con hospitalización relacionada con COVID-19 o muerte por cualquier causa hasta el día 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - through day 28
    -hasta el día 28.
    E.5.2Secondary end point(s)
    - Incidence of TEAEs.
    - Incidence of SAEs and AEs leading to discontinuations.
    - Time (days) to sustained alleviation of all targeted signs/symptoms through Day 28.
    - Proportion of participants with severe signs/symptoms attributed to COVID-19 through Day 28.
    - Time (days) to sustained resolution of all targeted signs/symptoms through Day 28.
    - Duration of each targeted COVID 19 sign/symptom.
    - Progression to a worsening status in 1 or more self reported COVID 19 associated symptoms through Day 28.
    - Proportion of participants with a resting peripheral oxygen saturation ≥95% at Days 1 and 5.
    - Proportion of participants with death (all cause) through Week 24.
    - PF 07321332 PK in plasma and whole blood (if feasible).
    - Viral titers measured via RT-PCR in nasal swabs over time.
    - Number of COVID-19 related medical visits through Day 28.
    - Number of days in hospital and ICU stay in participants with COVID-19 related hospitalization.
    - Incidencia de AAET.
    - Incidencia de AAG y AA que conducen a interrupciones.
    - Tiempo (días) hasta el alivio sostenido de todos los signos/síntomas tratados hasta el día 28.
    - Proporción de participantes con signos/síntomas graves atribuidos a la COVID-19 hasta el día 28.
    - Tiempo (días) hasta la resolución sostenida de todos los signos/síntomas tratados hasta el día 28.
    - Duración de cada signo/síntoma de COVID-19 tratado.
    - Progresión a un estado de empeoramiento en 1 o más síntomas asociados a la COVID-19 facilitados por los pacientes hasta el día 28.
    - Proporción de participantes con saturación de oxígeno periférica en reposo ≥95 % en los días 1 y 5.
    - Proporción de participantes con muerte (todas las causas) hasta la semana 24.
    - FC de PF-07321332 FC en plasma y sangre completa (si es posible).
    - Concentraciones víricas medidas mediante RT-PCR en hisopos nasales con el tiempo.
    - Cantidad de visitas médicas relacionadas con COVID-19 hasta el día 28.
    - Cantidad de días de hospitalización y estancia en la UCI en participantes con hospitalización relacionada con COVID-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    a lo largo del estudio
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 trial2
    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.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Bulgaria
    China
    Colombia
    Czechia
    Hungary
    India
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Peru
    Poland
    Puerto Rico
    Russian Federation
    South Africa
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days2
    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: 2034
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 226
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 2260
    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)
    None
    Ninguno
    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 Decision2021-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
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