Ensayo multicéntrico, adaptativo, aleatorizado y controlado sobre la seguridad y eficacia de las estrategias antitrombóticas en adultos hospitalizados con COVID-19

Dades bàsiques

Protocol:: NCT04505774
EURDRACT:: 2020-004285-19
NCT:
Centre:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
Any de finalització:: 2024

ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Determinar la estrategia antitrombótica más eficaz para aumentar el número de días libres de soporte de órganos y reducir la muerte. Objetivos Secundarios: Para determinar la estrategia antitrombótica más eficaz en el punto final compuesto de la muerte, trombosis venosa profunda (TVP), embolia pulmonar (EP), infarto de miocardio (MI), accidente cerebrovascular isquémico u otra trombosis arterial sistémica (AT). Evaluar la seguridad de las estrategias antitrombóticas a través de la variable de sangrado mayor según lo definido por ISTH. Comparar el efecto de las estrategias antitrombóticas en la variable de mortalidad por todas las causas en la población del estudio. La evaluación de la eficacia y la seguridad producirá información sobre el beneficio clínico neto de las diferentes estrategias antitrombóticas en la población del estudio. También proporcionará información sobre los resultados específicos de las poblaciones minoritarias subrepresentadas, específicamente las personas de ascendencia africana e hispana.

Documents

No hi ha documents

Participants

Miguel Ángel Roig Osca

Investigador Colaborador
Sandra Cuéllar Tovar

Data Manager / Study Coordinator
Carmen Morata Aldea

Investigador Colaborador
Marta Montero Alonso

Investigador Principal
Miguel Salavert Lletí

Investigador Colaborador
Inmaculada Segarra Granell

Data Manager / Study Coordinator
Juan Antonio Fernández Navarro

Investigador Colaborador
José Antonio Todolí Parra

Investigador Colaborador
María Tasias Pitarch

Investigador Colaborador
Luis Gil Sánchez

Investigador Colaborador
Pablo Berrocal Gil

Investigador Colaborador
Jon Ortiz Carrera

Investigador Colaborador

Grups d'Investigació

Infección Grave

Investigador Principal

María Ángeles Tormo Mas
Investigacion clínica en enfermedades crónicas e Infección por el VIH

Investigador establecido

Marta Montero Alonso
Unidad Mixta de Investigación en Nanomedicina y Sensores

Leader

Ramón Martínez Máñez

Finançadors - Promotors

FUNDACIÓN DE INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO LA PAZ

Resultats de l'Assaig Clínic

Publicacions en Revistes 134

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

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A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

A Randomized Trial of Dolutegravir Plus Darunavir/Cobicistat as a Switch Strategy in HIV-1-Infected Patients With Resistance to at Least 2 Antiretroviral Classes.

Santos JR; (...); Paredes R

Article. 10.1093/ofid/ofad542. 2023

Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial.

Tenorio CH; (...); Vallecillos CG

Article. 10.1016/j.ijantimicag.2024.107164. 2024

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

Climate change, animals, and Candida auris: insights into the ecological niche of a new species from a one health approach.

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Article. 10.1016/j.cmi.2023.03.016. 2023

Clinical Features and Outcomes Associated with Bronchial Asthma Among COVID-19 Hospitalized Patients.

Diaz, Miguel Angel; (...); De Diego, Alfredo

Article. 10.2147/JAA.S354082. 2022

Clinical management of cUTI, cIAI, and HABP/VABP attributable to carbapenem-resistant Gram-negative infections in Spain

Ferrer, Ricard; (...); McCann, Eilish

Article. 10.37201/req/096.2021. 2021

Clinicopathological characteristics of cutaneous and mucocutaneous leishmaniasis in patients treated with TNF-alpha inhibitors.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007. 2023

CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.

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Article. 10.1016/j.jtct.2024.01.082. 2024

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

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Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

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Article. 10.1016/j.farma.2023.04.002. 2023

Corrigendum to "Safety and effectiveness of isavuconazole in real-life non-neu tropenic patients" [International Journal of Infectious Diseases 144 (2024) 107070].

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Correction. 10.1016/j.ijid.2024.107188. 2024

Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.

Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina

Article. 10.1093/mmy/myac038. 2022

Dalbavancin in clinical practice in Spain: a 2 year retrospective study.

Morata, Laura; (...); Almirante, Benito

Article. 10.1093/jacamr/dlac120. 2022

Dalbavancin real-life utilization among diabetic patients suffering from infections in Italy and Spain: The DALBADIA retrospective cohort study.

Morata Ruiz L; (...); Grossi PA

Article. 10.1016/j.jgar.2023.11.015. 2024

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57).

Podzamczer D; (...); Moreno S

Article. 10.1093/ofid/ofab595. 2022

Decalogue for the selection of oral antibiotics for lower respiratory tract infections

Canton, Rafael; (...); Gonzalez del Castillo, Juan

Article. 10.37201/req/172.2021. 2022

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

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Article. 10.1016/j.carrev.2021.11.015. 2021

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Differences in epidemiology and mortality between men and women with HIV infection in the CoRIS cohort from 2004 to 2014.

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Article. 10.1016/j.eimce.2021.07.003. 2021

Dysimmunity in common variable immunodeficiency is associated with alterations in oral, respiratory, and intestinal microbiota.

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Article. 10.1016/j.clim.2023.109796. 2023

Early Detection of Cancer and Precancerous Lesions in Persons with HIV through a Comprehensive Cancer Screening Protocol.

Gutierrez, Felix; (...); Masia, Mar

Article. 10.1093/cid/ciae359. 2024

Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in HIV late presenters

Corona, Diana; (...); Rivero, Antonio

Article. 10.1016/j.ijantimicag.2023.107016. 2024

Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.

Santos JR; (...); Paredes R

Article. 10.3389/fcimb.2023.1187999. 2023

Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single-tablet regimen in treatment-naive and treatment-experienced patients

Suarez-Garcia, I.; (...); Jarrin, I.

Meeting Abstract. 2021

Efficacy and Safety of Anakinra Plus Standard of Care for Patients With Severe COVID-19: A Randomized Phase 2/3 Clinical Trial.

Fanlo P; (...); GEAS-SEMI Group

Article. 10.1001/jamanetworkopen.2023.7243. 2023

Efficacy and safety of dolutegravir/rilpivirine in real-world clinical practice. GeSIDA study 1119.

Palacios, R.; (...); Santos, J.

Article. 10.1111/hiv.13489. 2023

eGFR-EPI changes among HIV patients who switch from F/TDF to F/TAF while maintaining the same third agent in the Spanish VACH cohort

Teira, R; (...); Espinosa, N

Article. 10.1080/25787489.2021.1955197. 2021

Expert Consensus: Main Risk Factors for Poor Prognosis in COVID-19 and the Implications for Targeted Measures against SARS-CoV-2.

Candel, Francisco Javier; (...); On Behalf Of The Modus Investigators Adenda

Article. 10.3390/v15071449. 2023

Exposure to different occupational chemicals and clinical phenotype of a cohort of patients with systemic sclerosis.

Freire, Mayka; (...); Simeon-Aznar, Carmen Pilar

Letter. 10.1016/j.autrev.2024.103542. 2024

External clinical validation of automated software to identify structural abnormalities and microhaemorrhages in nailfold videocapillaroscopy images.

Gracia Tello, Borja C; (...); Fanlo, P.

Article. 10.55563/clinexprheumatol/m6obl3. 2023

Factors associated with late presentation for HIV care in adolescents in Spain

Epalza, Cristina; (...); Luisa Navarro, Maria

Article. 10.1111/hiv.13407. 2022

Fidaxomicin monotherapy versus standard therapy combined with bezlotoxumab for treating patients with Clostridioides difficile infection at high risk of recurrence: a matched cohort study

Escudero-Sanchez, Rosa; (...); Cobo Reinoso, Javier

Article. 10.1093/jac/dkac106. 2022

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection.

Masiá M; (...); Martínez E

Article. 10.1186/s13063-021-05777-6. 2021

Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection (vol 22, 851, 2021)

Masia, M.; (...); Martinez, E.

Correction. 10.1186/s13063-023-07655-9. 2023

IP-10 and MIG are sensitive markers of early virological response to HIV-1 integrase inhibitors.

Álvarez H; (...); Poveda E

Article. 10.3389/fimmu.2023.1257725. 2023

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Klinisch-pathologische Eigenschaften kutaner und mukokutaner Leishmaniose bei mit TNF-a-Inhibitoren behandelten Patienten.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007_g. 2023

Left ventricular diastolic dysfunction in systemic sclerosis: Clinical, immunological and survival differences in the Spanish RESCLE registry.

González García A; (...); Simeón Aznar CP

Article. 10.1016/j.semarthrit.2022.152033. 2022

Linking Microbiota Profiles to Disease Characterization in Common Variable Immunodeficiency: The Case of Granulomatous-Lymphocytic Interstitial Lung Disease.

Cabanero-Navalon MD; (...); Garcia-Bustos V

Article. 10.3390/biomedicines12102239. 2024

Long or complicated mpox in patients with uncontrolled HIV infection.

Corma-Gómez A; (...); Macías J

Article. 10.1002/jmv.29511. 2024

Long term follow-up in HCV infected patients with end stage chronic kidney disease after DAA therapy

Martinez-Camprecios, J; (...); Buti, M

Meeting Abstract. 2021

Long-term evolution in liver disease markers and immune and lipid profiles in vertically HIV/HCV-coinfected youths with sustained viral response after direct-acting antivirals therapy.

Tarancon-Diez, Laura; (...); Muñoz-Fernández MÁ

Article. 10.1016/j.biopha.2023.114587. 2023

Long-term follow-up of HCV-infected patients with end-stage chronic kidney disease after sustained virological response with direct-acting antiviral therapy

Martinez-Camprecios, Joan; (...); Buti, Maria

Article. 10.1016/j.gastrohep.2022.12.004. 2023

Long-term impact of immediate versus deferred antiretroviral therapy on kidney health in people with HIV.

Pelchen-Matthews, Annegret; (...); Wyatt, Christina M.

Article. 10.1016/j.kint.2024.04.010. 2024

Malignancies among children and young people with HIV in Western and Eastern Europe and Thailand

Chiappini, Elena; (...); Yannoulias, A.

Article. 10.1097/QAD.0000000000002965. 2021

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

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Article. 10.20960/nh.03946. 2022

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022

Monocyte Activation and Ageing Biomarkers in the Development of Cardiovascular Ischaemic Events or Diabetes in People with HIV.

Bernardino, Jose I.; (...); Rodes, Berta

Article. 10.3390/microorganisms11071818. 2023

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

Nailfold videocapillaroscopy patterns in systemic sclerosis: implications for cutaneous subsets, disease features and prognostic value for survival.

Tolosa-Vilella, Carles; (...); Simeon-Aznar, Carmen Pilar

Article. 10.55563/clinexprheumatol/8lrofr. 2023

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

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Review. 10.3390/biology12091159. 2023

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

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Correction. 10.3389/fped.2021.834454. 2022

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

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Article. 10.7399/fh.11719. 2021

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

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Article. 2021

Reduction in the risk of progression of solid organ transplant recipients infected by SARS-CoV-2 treated with monoclonal antibodies

Javier Candel, Francisco; (...); Cuervo Pinto, Rafael

Review. 10.37201/req/023.2023. 2023

Response to Vaccines in Patients with Immune-Mediated Inflammatory Diseases: A Narrative Review.

Garcillan, Beatriz; (...); Diaz-Castroverde, Sabela

Article. 10.3390/vaccines10020297. 2022

Role of previous systemic antibiotic therapy on the probability of recurrence after an initial episode of Clostridioides difficile infection treated with vancomycin.

Merchante, Nicolas; (...); Merino, Esperanza

Article. 10.1093/jacamr/dlad033. 2023

Safety and effectiveness of isavuconazole in real-life non-neutropenic patients.

Monzo-Gallo, Patricia; (...); Garcia-Vidal, Carolina

Article. 10.1016/j.ijid.2024.107070. 2024

Shorter Time to Discontinuation Due to Treatment Failure in People Living with HIV Switched to Dolutegravir Plus Either Rilpivirine or Lamivudine Compared with Integrase Inhibitor-Based Triple Therapy in a Large Spanish Cohort

Teira, Ramon; (...); Curran, Adria

Article. 10.1007/s40121-022-00630-y. 2022

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

Standardized incidence ratios and risk factors for cancer in patients with systemic sclerosis: Data from the Spanish Scleroderma Registry (RESCLE).

Carbonell C; (...); Simeón-Aznar CP

Article. 10.1016/j.autrev.2022.103167. 2022

Switching to bictegravir/ emtricitabine/tenofovir alafenamide plus darunavir/cobicistat in heavily antiretroviralexperienced, virologically suppressed HIV-infected adults receiving complex regimens: 48-week analysis

Podzamczer, D.; (...); Rivero, A.

Meeting Abstract. 2023

Switching to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) plus darunavir/cobicistat in heavily antiretroviral-experienced, virologically suppressed HIV-infected adults receiving complex regimens.

Podzamczer, Daniel; (...); Rivero, Antonio

Article. 10.1093/jac/dkad285. 2023

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

What Do We Know about Candida auris ? State of the Art, Knowledge Gaps, and Future Directions.

Garcia-Bustos V; (...); Pemán J

Article. 10.3390/microorganisms9102177. 2021