Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection

Sponsor
University of Sao Paulo
Study ID
NCT04600141
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab infusion 8mg/kg/dose - Intravenous single dose.
  • Heparin - Therapeutic dosage — DRUG
    Intravenous Non-Fractional Heparine (HNF) starting at 18UI/kg/h adjusted according to a nomogram to achieve an Activated Partial Thromboplastin Time (ATTP) from 1.5 To 2.0 times the reference Value; or Low Molecular Weight Heparin (LMWH) subcutaneous dosage of 1mg/kg per dose every 12 hours
  • Heparin - Prophylactic dosage — DRUG
    Subcutaneous Non-Fractional Heparine 5000U every 8 hours OR Subcutaneous Low Molecular Weight (LMWH) 40mg/day.

Study Details

The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.

Key Dates

Start date
Nov 10, 2020
Status verified
Mar 2022
Primary completion
Oct 20, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
308 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1 - Therapeutic anticoagulation
    * (I) intravenous UFH started at a dose of 18 IU/kg/h, adjusted according to a nomogram to achieve a TTPa of 1.5 to 2.0 times the reference value; OR * (II) subcutaneous LMWH - enoxaparin 1 mg / kg per dose every 12 hours.
  • Active Comparator: Group 2 - Prophylactic anticoagulation
    * (I) subcutaneous UFH 5,000 IU every 8 hours; OR * (II) subcutaneous LMWH - enoxaparin 40 mg daily.
  • Experimental: Group 3 - Therapeutic anticoagulation with tocilizumab
    * (I) Intravenous UFH initiated at a dose of 18 IU / kg / h, adjusted according to a nomogram to achieve a TTPa of 1.5 to 2.0 times the reference value associated with 8 mg / kg / tocilizumab infusion / intravenous dose in a single dose; OR * Subcutaneous LMWH - enoxaparin 1 mg / kg per dose every 12 hours associated with an infusion of tocilizumab 8 mg / kg / dose in a single dose.
  • Experimental: Group 4 - Prophylactic anticoagulation with tocilizumab
    * (I) subcutaneous UFH 5,000 IU every 8 hours associated with an infusion of tocilizumab 8 mg / kg / intravenous dose in a single dose; OR * (II) subcutaneous LMWH - enoxaparin 40 mg daily associated with an infusion of tocilizumab 8 mg / kg / intravenous dose in a single dose.

Primary Outcome Measure

Proportion of patients with clinical improvement [ Time Frame: 30 days ]

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