Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
COVID Coronavirus Infection Severe Acute Respiratory Syndrome Thromboembolism, Venous Anticoagulants and Bleeding Disorders Drug: Therapeutic anticoagulation Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19
Actual Study Start Date : July 4, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Therapeutic anticoagulation
Therapeutic anticoagulation with enoxaparin 1 mg/Kg twice daily.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 28 days ]
    All-cause death

  2. Composite outcome of ICU admission or all-cause death [ Time Frame: 28 days ]
    Composite outcome of ICU admission or all-cause death

  3. Major bleeding [ Time Frame: 28 days ]
    Major bleeding

  4. Number of participants who received red blood cell transfusion [ Time Frame: 28 days ]
    Red Blood Cell transfusion (greater than or equal to 1 unit)

  5. 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

  6. Number of hospital-free days alive up to day 28 [ Time Frame: 28 days ]
    Hospital-free days alive up to day 28

  7. Number of ICU-free days alive up to day 28 [ Time Frame: 28 days ]
    ICU-free days alive up to day 28

  8. Number of ventilator-free days alive up to day 28 [ Time Frame: 28 days ]
    Ventilator-free days alive up to day 28

  9. Number of participants with venous thromboembolism [ Time Frame: 28 days ]
    Venous thromboembolism

  10. Number of participants with arterial thromboembolism [ Time Frame: 28 days ]
    Arterial thromboembolism

  11. Number of participants with heparin induced thrombocytopenia [ Time Frame: 28 days ]
    Heparin induced thrombocytopenia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04444700


Contacts
Layout table for location contacts
Contact: Hassan Rahhal, MD +551126619033 hassan.r@hc.fm.usp.br

Locations
Layout table for location information
Brazil
Hospital das Clínicas da FMUSP Recruiting
São Paulo, SP, Brazil, 05402-000
Contact: Hassan Rahhal, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
St. Michael's Hospital, Toronto
University of Vermont Medical Center
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04444700    
Other Study ID Numbers: CAAE: 33109220.7.0000.0068
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Thromboembolism
Hemostatic Disorders
Venous Thromboembolism
Blood Coagulation Disorders
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hematologic Diseases
Hemorrhagic Disorders