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    Summary
    EudraCT Number:2021-000748-24
    Sponsor's Protocol Code Number:TF-TF0023-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-07-11
    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 number2021-000748-24
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind (Within Dose), Placebo-controlled, Parallel-group, and Dose-range-finding Study to Evaluate the Efficacy and Safety of TF0023 Versus Placebo in Treatments for COVID-19 in Hospitalized Adults
    Estudio de fase 2, multicéntrico, aleatorizado, en doble ciego (dentro del nivel de dosis), controlado con placebo, de grupos paralelos y búsqueda de dosis, para evaluar la eficacia y seguridad de TF0023 frente a placebo en el tratamiento de la COVID-19 en adultos hospitalizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study to Evaluate the Efficacy and Safety of TF0023 compared to Placebo in Treatments for COVID-19 in Hospitalized Adults
    Estudio de fase 2 para evaluar la eficacia y seguridad de TF0023 frente a placebo en el tratamiento de la COVID-19 en adultos hospitalizados
    A.4.1Sponsor's protocol code numberTF-TF0023-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05212818
    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 SponsorTechfields 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 supportTechfields Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechfields Inc.
    B.5.2Functional name of contact pointA. Director of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address731 Alexander Road
    B.5.3.2Town/ cityPrinceton, NJ
    B.5.3.3Post code08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1.512.653.9306
    B.5.6E-mailJustin.Rudolph@tfpharma.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 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.3.2Product code TF0023
    D.3.4Pharmaceutical form Powder and solvent for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeTF0023
    D.3.9.3Other descriptive name2-(diethylamino)ethyl 2-acetyloxybenzoate hydrochloride
    D.3.9.4EV Substance CodeSUB255110
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1582
    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 placeboPowder and solvent for cutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 infection
    Infección por COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infección por COVID-19
    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 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.
    E.2.2Secondary 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.2.3Trial contains a sub-study Yes
    E.2.3.1Full 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.
    E.3Principal 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)
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Día 15
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Day 1 to Day 29
    Desde el día 1 hasta el día 29
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    South Africa
    United States
    France
    Bulgaria
    Romania
    Spain
    Ukraine
    E.8.7Trial 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
    LPLV
    Último paciente, última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    F.4.2.2In the whole clinical trial 400
    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 Decision2022-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-08
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