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A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic (RAPID-BRAZIL)

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ClinicalTrials.gov Identifier: NCT04444700
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
University of Vermont Medical Center
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 23, 2020
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE July 4, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
Composite main outcome [ Time Frame: up to 28 days ]
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • All-cause death [ Time Frame: 28 days ]
    All-cause death
  • Composite outcome of ICU admission or all-cause death [ Time Frame: 28 days ]
    Composite outcome of ICU admission or all-cause death
  • Major bleeding [ Time Frame: 28 days ]
    Major bleeding
  • Number of participants who received red blood cell transfusion [ Time Frame: 28 days ]
    Red Blood Cell transfusion (greater than or equal to 1 unit)
  • Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate. [ Time Frame: 28 days ]
    Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
  • Number of hospital-free days alive up to day 28 [ Time Frame: 28 days ]
    Hospital-free days alive up to day 28
  • Number of ICU-free days alive up to day 28 [ Time Frame: 28 days ]
    ICU-free days alive up to day 28
  • Number of ventilator-free days alive up to day 28 [ Time Frame: 28 days ]
    Ventilator-free days alive up to day 28
  • Number of participants with venous thromboembolism [ Time Frame: 28 days ]
    Venous thromboembolism
  • Number of participants with arterial thromboembolism [ Time Frame: 28 days ]
    Arterial thromboembolism
  • Number of participants with heparin induced thrombocytopenia [ Time Frame: 28 days ]
    Heparin induced thrombocytopenia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic
Official Title  ICMJE Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19
Brief Summary

Published papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death.

Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Coronavirus Infection
  • Severe Acute Respiratory Syndrome
  • Thromboembolism, Venous
  • Anticoagulants and Bleeding Disorders
Intervention  ICMJE Drug: Therapeutic anticoagulation
Therapeutic anticoagulation with enoxaparin 1 mg/Kg twice daily.
Study Arms  ICMJE
  • Experimental: Therapeutic anticoagulation

    Therapeutic anticoagulation with enoxaparin 1 mg/Kg BID will be administered until discharged from the hospital or after 7 days, whichever is longer, or death.

    If the patient is admitted to the ICU or requiring ventilatory support, we recommend the continuation of the allocated treatment as long as the treating physician is in agreement.

    Intervention: Drug: Therapeutic anticoagulation
  • No Intervention: Standard care

    Standard care will be administered until discharged from the hospital or after 7 days, whichever is longer, or death.

    If BMI less than 40 Kg/m², the treating physician may select one of the following options considered appropriate and available in Brazil:

    Enoxaparin 40 mg once daily, enoxaparin 60 mg once daily, UFH 5,000 twice daily, UFH 5,000 thrice daily.

    If BMI equals to or greater than 40 Kg/m², the treating physician may select one of the following options considered appropriate and available in Brazil:

    Enoxaparin 40 mg BID, UFH 7,500 TID.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
462
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Laboratory confirmed diagnosis of SARS-CoV-2 as per the World Health Organization protocols;
  • Admitted to hospital;
  • ≥18 years of age;
  • Oxygen saturation lower than 94%;
  • Informed consent from the patient (or legally authorized substitute decision maker).

Exclusion Criteria:

  • pregnancy;
  • hemoglobin <80 g/L in the last 72 hours;
  • platelet count <50 x 109/L in the last 72 hours;
  • known fibrinogen <1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
  • known INR >1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
  • patient already on intermediate dosing of LMWH that cannot be changed (determination of what constitutes an intermediate dose is to be at the discretion of the treating clinician taking the local institutional thromboprophylaxis protocol for high risk patients into consideration);
  • patient already on therapeutic anticoagulation at the time of screening (low or high dose nomogram UFH, LMWH, warfarin, direct oral anticoagulant (any dose of dabigatran, apixaban, rivaroxaban, edoxaban);
  • patient on dual antiplatelet therapy, when one of the agents cannot be stopped safely;
  • known bleeding within the last 30 days requiring emergency room presentation or hospitalization;
  • known history of a bleeding disorder of an inherited or active acquired bleeding disorder;
  • known history of heparin-induced thrombocytopenia;
  • known allergy to UFH or LMWH;
  • admitted to the intensive care unit at the time of screening;
  • treated with non-invasive positive pressure ventilation or invasive mechanical ventilation at the time of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hassan Rahhal, MD +551126619033 hassan.r@hc.fm.usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04444700
Other Study ID Numbers  ICMJE CAAE: 33109220.7.0000.0068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE
  • St. Michael's Hospital, Toronto
  • University of Vermont Medical Center
Investigators  ICMJE
Principal Investigator: Peter Juni, MD, FESC St Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto
Principal Investigator: Elnara M Negri, MD, PhD Laboratório de Investigação Médica da FMUSP
Principal Investigator: Heraldo P de Souza, MD, PhD Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP
Principal Investigator: Hassan Rahhal, MD Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP
PRS Account University of Sao Paulo General Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP