Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19)

Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19) - Heparin-SARS-CoV2

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001891-14-ES

Enrollment

140

Registered

2020-05-05

Start date

2020-05-04

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ENOXAPARIN SODIUM CAS Number: 9041-08-1 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old 2. Signature of informed consent 3. Diagnosis by positive PCR for SARS-CoV2 infection 4. They require hospital admission due to fever and other of the established CoV2 admission criteria. 5. Patients with a weight greater than or equal to 60 Kg. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: 1. Allergy to LMWH. 2. Contraindication for anticoagulation (platelets <25 x 10E9 / L or severe active bleeding, major or clinically relevant bleeding) 3. Pregnancy. 4. Patients with extreme weights. BMI greater than 40. 5. Need for chronic anticoagulant treatment. 6. Need for treatment with high-flow oxygen therapy or mechanical ventilation at the time of study recruitment (within the first 24 hours after admission). 7. Participation in another disease treatment trial venous thromboembolic.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of treatment with LMWH, using prophylactic versus intermediate doses, in terms of escalation in oxygen therapy or the need for invasive mechanical ventilation or mortality in patients admitted with SARS-CoV2 infection;Secondary Objective: Know the safety of LMWH guideline used in terms of bleeding events, days in hospital and to establish the most favorable patient profile for LMWH treatment.;Primary end point(s): Need for oxygen therapy escalation due to oxygen saturation (Sat O2) =92% with inspired fraction of oxygen (FiO2) =0.5 and respiratory rate (FR) =30 (IROX index = SatO2 / FiO2] / FR <5.5) or invasive mechanical ventilation or mortality during admission.;Timepoint(s) of evaluation of this end point: 30 días	—

Measure

Time frame

Main Objective: To assess the impact of treatment with LMWH, using prophylactic versus intermediate doses, in terms of escalation in oxygen therapy or the need for invasive mechanical ventilation or mortality in patients admitted with SARS-CoV2 infection;Secondary Objective: Know the safety of LMWH guideline used in terms of bleeding events, days in hospital and to establish the most favorable patient profile for LMWH treatment.;Primary end point(s): Need for oxygen therapy escalation due to oxygen saturation (Sat O2) =92% with inspired fraction of oxygen (FiO2) =0.5 and respiratory rate (FR) =30 (IROX index = SatO2 / FiO2] / FR <5.5) or invasive mechanical ventilation or mortality during admission.;Timepoint(s) of evaluation of this end point: 30 días

—

Secondary

Measure	Time frame
Secondary end point(s): Need for rescue medication (eg, parenteral corticosteroids, tocilizumab) and days of hospital stay in surviving patients.;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Spain

Contacts

Public ContactAlejandro

Delos Clinical

secretaria@delosclinical.com+34630157890

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026