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

Phase 1

Active, not recruiting

Conditions: COVID-19
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-001891-14-ES

Lead Sponsor: Fundación Neumosur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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