Hemostasis in COVID-19: an Adaptive Clinical Trial
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|ClinicalTrials.gov Identifier: NCT04466670|
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: unfractionated Heparin Drug: Unfractionated heparin nebulized Drug: acetylsalicylic acid Drug: Enoxaparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial|
|Estimated Study Start Date :||July 8, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||April 30, 2021|
|No Intervention: phase 1|
|Experimental: phase 2A||
Drug: unfractionated Heparin
Unfractionated heparin dosed to target anti-Xa level 0.3 - 0.7 IU/mL (if creatinine clearance less than 30ml/min), during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days.
Enoxaparin 1 mg/kg subcutaneously every 12 hours (if creatinine clearance greater than or equal to 30ml/min) during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days.
|Experimental: phase 2B||
Drug: Unfractionated heparin nebulized
unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days associated to thromboprophylaxis institutional protocol.
|Experimental: phase 2C||
Drug: acetylsalicylic acid
Aspirin (ASA) 100 mg daily PO during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days associated to thromboprophylaxis institutional protocol.
- Hospital discharge - alive / death [ Time Frame: 30 days ]Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
- Length of mechanical ventilation free days [ Time Frame: 30 days ]Comparison of length of mechanical ventilation free days between each treatment arm
- Length of renal replacement therapy free days [ Time Frame: 30 days ]Comparison of length of renal replacement therapy free days between each treatment arm
- Number of documented venous thromboembolism or arterial thrombosis [ Time Frame: 3 months ]Comparison of number of thrombosis events between each treatment arm.
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): NCT04466670
|Sao Paulo, Brazil, 05403-000|
|Contact: Vanderson Rocha, MD.PhD +55-11-26617575 firstname.lastname@example.org|
|Contact: Yeh-Li Ho, MD.PhD +55-11-26616045 email@example.com|
|Sub-Investigator: Yeh-Li Ho, MD.PhD|
|Sub-Investigator: Elbio A D'Amico, MD.PhD|
|Sub-Investigator: Paula R Villaca, MD.PhD|
|Sub-Investigator: Cynthia Rotschild, MD|
|Sub-Investigator: Erica Okazaki, MD|
|Sub-Investigator: Tania RF Rocha, MPharm|