NCT04508439

Brief Summary

Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs. The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 5, 2020

Last Update Submit

August 8, 2020

Conditions

Covid19PneumoniaCoagulation DisorderPulmonary Embolism

Keywords

Covid-19MortalityanticoagulantsDeep venous thrombosisPulmonary embolism

Outcome Measures

Primary Outcomes (4)

  • low molecular weight heparin (enoxaparin) and ventilatory support time

    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on ventilatory support time in patients requiring hospital care for COVID-19 infection.

    30 days

  • thrombotic complications and Rivaroxaban

    To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications

    30 days

  • low molecular weight heparin (enoxaparin) and length of hospital stay

    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the length of hospital stay in patients requiring hospital care for COVID-19 infection.

    30 days

  • low molecular weight heparin (enoxaparin) and mortality rate

    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.

    30 days

Study Arms (2)

Prophylactic enexaparin

EXPERIMENTAL

Enoxaparin dose of 1mg / kg / dose twice daily

Drug: Enoxaparin

Therapeutic Enoxaparin

ACTIVE COMPARATOR

Enoxaparin dose of 1mg / kg / dose daily

Drug: Enoxaparin

Interventions

EnoxaparinDRUG

Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the established clinical response due to lack of ventilatory support, length of hospital stay or death in patients requiring hospital care for COVID-19 infection.

Also known as: low molecular weight heparin
Prophylactic enexaparinTherapeutic Enoxaparin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of COVID-19 infection confirmed by polymerase chain reaction test (RQ-PCR) requiring hospital care for the administration of supplemental oxygen

You may not qualify if:

  • Patients with life expectancy less than 48hrs
  • Patients who require ventilatory support upon admission
  • Age over 75 years or with a history of atrial fibrillation
  • History of venous or arterial thrombosis
  • Severe neurological impairment
  • Absence of a primary caregiver to supervise the administration of medication
  • History of cerebral hemorrhage
  • History of previous use of oral anticoagulants
  • History of major surgery 30 days prior to admission
  • Uncontrolled systemic arterial hypertension
  • KDIGO stage III chronic kidney disease or less
  • Hemodialysis or peritoneal dialysis treatment
  • History of active or inactive cancer
  • Pregnant or postpartum patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional de Alta Especialidad de Ixtapaluca

Mexico City, Ixtapaluca, 56530, Mexico

RECRUITING

Related Publications (1)

  • Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.

    PMID: 37591523DERIVED

MeSH Terms

Conditions

COVID-19PneumoniaHemostatic DisordersPulmonary EmbolismVenous Thrombosis

Interventions

EnoxaparinHeparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolismEmbolism and ThrombosisThrombosis

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Omar Ramos-Peñafiel, MD, PhD

CONTACT

+525523351588christian.ramos.penafiel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: * Initially they will be randomized into two blocks, the first based on prophylactic Enoxaparin (Numbers 1 to 64) and the second (Numbers 65 to 128) will be assigned to the Enoxaparin therapeutic regimen arm at doses of 1mg / kg/dose twice up to date * During hospitalization, the clinical evolution will be evaluated according to the requirements of mechanical ventilation, the reduction in D-Dimer levels and the clinical outcome (discharge or death). * Those patients who are discharged will be Randomized in two following treatment arms * The allocation of patients in the outpatient stage will be carried out randomly 1: 1 to receive Rivaroxaban 10mg PO every 24hrs or only clinical follow-up. * Follow-up of adverse events will be carried out in the Hematology outpatient clinic with a first consultation 15 days after discharge and a second consultation 30 days after discharge. With dimer D, ferritin, protein C, blood count, ESR and on day 30 with CAT.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 11, 2020

Study Start

June 20, 2020

Primary Completion

August 30, 2020

Study Completion

December 30, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)