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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
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
|Contact: Hassan Rahhal, MDemail@example.com|
|Hospital das Clínicas da FMUSP||Recruiting|
|São Paulo, SP, Brazil, 05402-000|
|Contact: Hassan Rahhal, MD|
|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|