ROLE OF HEPARIN IN THE PREVENTION OF THROMBOEMBOLISM IN PATIENTS WITH COVID-19 AND RESPIRATORY FAILURE

EFFICACY AND SAFETY OF HEPARIN THROMBOPROPHYLAXIS IN PATIENTS WITH COVID-19 AND RESPIRATORY FAILURE: AN OPEN LABEL RANDOMIZED STUDY. The RESPECT-COVID (RESPiratory failure and hEparin Clinical Trial in patients with COVID-19) - RESPECT-COVID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005884-29-IT

Enrollment

652

Registered

2021-06-08

Start date

2021-04-28

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Patients with confirmed SARS-CoV-2 infection and respiratory failure will be randomized to receive two different doses of low molecular weight heparin (LMWH). MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Parnaparina Product Code: [Antitrombotici - derivati dell’eparina] Pharmaceutical Form: Solution for injection INN or Proposed INN: PARNAPARINA SODICA Current Sponsor code: NA Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Age >= 18 years - Diagnosis of COVID-19 confirmed by RT-PCR with pneumonia detected by chest X-ray or ultrasonography or computed tomography - Severe respiratory failure (PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 392

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Need for invasive mechanical ventilation - Any contraindication to LMWH (known hypersensitivity, history of heparin induced thrombocytopenia, stage IV or V renal failure,.. ) - Platelet count <30000/mmc - Indication for therapeutic anticoagulation - Evidence of active bleeding - Recent stroke in the preceding 4 weeks - Women who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The aims of this study, in patients with confirmed COVID-19 and respiratory failure receiving either standard LMWH or intermediate LMWH (2/3 of therapeutic dose) thromboprophylaxis, are: Primary a) to assess whether intermediate dose LMWH is more effective than standard LMWH prophylaxis in reducing the composite of all-cause death or invasive mechanical ventilation or venous thromboembolic events.;Secondary Objective: Secondary objectives b) to assess whether intermediate dose LMWH is more effective than standard LMWH prophylaxis in reducing venous thromboembolic events; c) to assess the safety of intermediate dose LMWH in comparison to standard LMWH prophylaxis in the incidence of major or clinically relevant non-major bleedings.;Primary end point(s): The primary study outcome is the composite of all-cause death or respiratory failure requiring invasive mechanical ventilation or confirmed venous thromboembolism, whichever comes first, within 28 days from randomization.;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: The aims of this study, in patients with confirmed COVID-19 and respiratory failure receiving either standard LMWH or intermediate LMWH (2/3 of therapeutic dose) thromboprophylaxis, are: Primary a) to assess whether intermediate dose LMWH is more effective than standard LMWH prophylaxis in reducing the composite of all-cause death or invasive mechanical ventilation or venous thromboembolic events.;Secondary Objective: Secondary objectives b) to assess whether intermediate dose LMWH is more effective than standard LMWH prophylaxis in reducing venous thromboembolic events; c) to assess the safety of intermediate dose LMWH in comparison to standard LMWH prophylaxis in the incidence of major or clinically relevant non-major bleedings.;Primary end point(s): The primary study outcome is the composite of all-cause death or respiratory failure requiring invasive mechanical ventilation or confirmed venous thromboembolism, whichever comes first, within 28 days from randomization.;Timepoint(s) of evaluation of this end point: 28 days

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Secondary

Measure	Time frame
Secondary end point(s): The secondary study outcomes are: a) confirmed venous thromboembolism within 28 days from randomization;; The secondary study outcomes are: b) major or clinically relevant non-major bleedings within 28 days from randomization.; The secondary study outcomes are: c) confirmed venous thromboembolism or persistent respiratory failure with need for oxygen therapy at 3 months from randomization.;Timepoint(s) of evaluation of this end point: 28 days; 28 days; 3 months	—

Measure

Time frame

Secondary end point(s): The secondary study outcomes are: a) confirmed venous thromboembolism within 28 days from randomization;; The secondary study outcomes are: b) major or clinically relevant non-major bleedings within 28 days from randomization.; The secondary study outcomes are: c) confirmed venous thromboembolism or persistent respiratory failure with need for oxygen therapy at 3 months from randomization.;Timepoint(s) of evaluation of this end point: 28 days; 28 days; 3 months

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Countries

Italy

Contacts

Public ContactS.C. Medicina Interna, Vascolare e

Università degli Studi di Perugia

mariacristina.vedovati@unipg.it

Outcome results

None listed

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