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Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID) | Clinical Trials | Clareo Health

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Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)

NCT04730856•Hospital Universitario Infanta Leonor

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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)
•2. Patients with, at least, one of the following evolution disease risk criteria:
•* Sat 02\<94%
•* Need for oxygen therapy or pAO2/FiO2\<300mmHg or estimated PaO2/FiO2 based on SpO2/FiO2\<300 mmHg.
•* DD\>1000µg/L
•* PCR \>150mg/L
•* IL6 \>40pg/ml
•3. Age \> 18 years
•4. Weight 50-100 Kg
•5. 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.

Exclusion Criteria

•1. Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
•2. Current diagnosis of acute bronchial asthma attack.
•3. History or clinical suspicion of pulmonary fibrosis.
•4. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
•5. Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
•6. Patients with pneumonectomy or lobectomy.
•7. Renal failure with Glomerular filtration \<30 ml/min/1.73m2
•8. Patients with contraindication for anticoagulant treatment.
•9. Congenital bleeding disorders.
•10. Hypersensitivity to tinzaparin or UFH or some of its excipients.
+7 more criteria

Locations (18)

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitario del Vinalopó

Alicante, Spain

Hospital Clínic Barcelona

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Virgen de la Luz

Cuenca, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital de Emergencias Enfermera Isabel Zendal

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Key Dates

Start Date

February 1, 2021

Primary Completion Date

October 20, 2021

Completion Date

December 20, 2021

Last Updated

September 15, 2022

Enrollment

311

ACTUAL participants

Conditions

Covid19Thrombosis

Interventions

Tinzaparin

DRUG

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

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Cancer-Associated Thrombosis (CAT)

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RECRUITINGPHASE1

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)

Inclusion Criteria

Exclusion Criteria

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