Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT04730856
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078222', 'term': 'Tinzaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined variable that includes outcomes 2, 3 and 4 detailed below', 'timeFrame': '30 days', 'description': 'Combined variable that includes outcomes 2, 3 and 4 detailed below (reduction of suspicion of systemic thrombotic symptomatic events and/or need for mechanical ventilation and/or death at day 30 after randomization).'}, {'measure': 'Reduction of suspicion of systemic thrombotic symptomatic events', 'timeFrame': '30 days', 'description': 'Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.'}, {'measure': 'Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen', 'timeFrame': '30 days', 'description': 'Mechanical ventilation (invasive or non-invasive) free survival.'}, {'measure': 'Overall survival at 30 days.', 'timeFrame': '30 days', 'description': 'Overall survival at 30 days: number of deaths.'}], 'secondaryOutcomes': [{'measure': 'Number of bleedings and adverse reactions', 'timeFrame': '90 days', 'description': 'Safety of the different strategies of prophylaxis and anticoagulation: number of bleedings and adverse reactions in each group:\n\nEvaluation of the following variables:\n\nIncidence of major bleeding, defined as meeting any of these criteria:\n\na) fatal bleeding or bleeding that occurs in a critical area or organ (for example, intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), b ) causes a drop in hemoglobin level of 20 g/L or more, or c) requires the transfusion of 2 or more units of whole blood or packed red blood cells.\n\nIncidence of clinically relevant non-major bleeding: manifest, spontaneous or post-traumatic bleeding, which does not meet the criteria for major bleeding but which in the judgment of the investigator is relevant.\n\nIncidence of clinically relevant bleeding: all major and non-major hemorrhages clinically relevant.\n\nIncidence of adverse reactions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Thrombosis']}, 'referencesModule': {'references': [{'pmid': '12865379', 'type': 'BACKGROUND', 'citation': 'Lew TW, Kwek TK, Tai D, Earnest A, Loo S, Singh K, Kwan KM, Chan Y, Yim CF, Bek SL, Kor AC, Yap WS, Chelliah YR, Lai YC, Goh SK. Acute respiratory distress syndrome in critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):374-80. doi: 10.1001/jama.290.3.374.'}, {'pmid': '32311448', 'type': 'BACKGROUND', 'citation': 'Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quere I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17.'}, {'pmid': '32171076', 'type': 'BACKGROUND', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}, {'pmid': '31986264', 'type': 'RESULT', 'citation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.'}, {'pmid': '36233500', 'type': 'DERIVED', 'citation': 'Munoz-Rivas N, Aibar J, Gabara-Xanco C, Trueba-Vicente A, Urbelz-Perez A, Gomez-Del Olmo V, Demelo-Rodriguez P, Rivera-Gallego A, Bosch-Nicolau P, Perez-Pinar M, Rios-Prego M, Madridano-Cobo O, Ramos-Alonso L, Alonso-Carrillo J, Francisco-Albelsa I, Marti-Saez E, Maestre-Peiro A, Mendez-Bailon M, Hernandez-Rivas JA, Torres-Macho J; PROTHROMCOVID Trial Investigators. Efficacy and Safety of Tinzaparin in Prophylactic, Intermediate and Therapeutic Doses in Non-Critically Ill Patients Hospitalized with COVID-19: The PROTHROMCOVID Randomized Controlled Trial. J Clin Med. 2022 Sep 24;11(19):5632. doi: 10.3390/jcm11195632.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to hospital with COVID-19, PCR and/or Antigens Test + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC)\n2. Patients with, at least, one of the following evolution disease risk criteria:\n\n * Sat 02\\<94%\n * Need for oxygen therapy or pAO2/FiO2\\<300mmHg or estimated PaO2/FiO2 based on SpO2/FiO2\\<300 mmHg.\n * DD\\>1000µg/L\n * PCR \\>150mg/L\n * IL6 \\>40pg/ml\n3. Age \\> 18 years\n4. Weight 50-100 Kg\n5. After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study.\n\nExclusion Criteria:\n\n1. Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.\n2. Current diagnosis of acute bronchial asthma attack.\n3. History or clinical suspicion of pulmonary fibrosis.\n4. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.\n5. Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.\n6. Patients with pneumonectomy or lobectomy.\n7. Renal failure with Glomerular filtration \\<30 ml/min/1.73m2\n8. Patients with contraindication for anticoagulant treatment.\n9. Congenital bleeding disorders.\n10. Hypersensitivity to tinzaparin or UFH or some of its excipients.\n11. History of heparin-induced thrombocytopenia.\n12. Active bleeding or situation that predispose to bleeding.\n13. Moderate or severe anaemia (Hb\\<10 g/dl)\n14. Low platelet count \\< 80000/µl\n15. Patients with life expectancy less than 3 months due to primary disease evaluated by the physician.\n16. Patients currently intubated or intubated between the screening and the randomization.\n17. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT04730856', 'briefTitle': 'Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Infanta Leonor'}, 'officialTitle': 'Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)', 'orgStudyIdInfo': {'id': 'PROTHROMCOVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tinzaparin 4500 UI/day', 'description': 'Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.', 'interventionNames': ['Drug: Tinzaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tinzaparin 100 UI/Kg/day', 'description': 'Procedure: Tinzaparin 100 UI/Kg/day SC until hospital discharge.', 'interventionNames': ['Drug: Tinzaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tinzaparin 175 UI/Kg/day', 'description': 'Procedure: Tinzaparin 175 UI/Kg/day SC until hospital discharge.', 'interventionNames': ['Drug: Tinzaparin']}], 'interventions': [{'name': 'Tinzaparin', 'type': 'DRUG', 'description': "day subcutaneously • Follow-up phase 1 (Day 15 to day 30): The information is obtained at discharge and on day +14, + 28 on 30 days. The latter information is obtained from patients, from medical records or by telephone contact at the patient's home.\n\n• Follow-up phase 2 (At 3 months: Information is obtained from patients, medical records, or by telephone contact at the patient's home.", 'armGroupLabels': ['Tinzaparin 100 UI/Kg/day', 'Tinzaparin 175 UI/Kg/day', 'Tinzaparin 4500 UI/day']}]}, 'contactsLocationsModule': {'locations': [{'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario del Vinalopó', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Cuenca', 'country': 'Spain', 'facility': 'Hospital Virgen de la Luz', 'geoPoint': {'lat': 40.06667, 'lon': -2.13333}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Universitari de Girona Doctor Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Emergencias Enfermera Isabel Zendal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Sofía', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Nuria Muñoz Rivas', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Infanta Leonor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Infanta Leonor', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}