Antithrombotic Therapy to Ameliorate Complications of COVID-19 ( ATTACC )
|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: NCT04372589|
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Pneumonia||Drug: Heparin||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pragmatic, Bayesian adaptive randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Antithrombotic Therapy to Ameliorate Complications of COVID-19|
|Actual Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Investigational arm
Participants randomized to the investigational arm will receive therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen >24 hours if previously required, whichever comes first) with heparin, with preference for subcutaneous low molecular weight heparin (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, intravenous unfractionated heparin infusion may be used.
Low molecular weight heparin (LMWH) Preferred therapeutic anticoagulant is enoxaparin. Generally regimens: 1.5 mg/kg subcutaneous once daily or 1 mg/kg subcutaneous twice daily. Alternatively, other subcutaneous LMWH used, including tinzaparin (175 anti-Xa IU/kg subcutaneous once daily) or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day).
Unfractionated heparin (UFH) Commenced, administered, and monitored according to local hospital policy, and guidelines that are used for the treatment of venous thromboembolism (i.e. not for acute coronary syndrome). Intravenous infusion of UFH is according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value. If UFH is used, the availability of a local hospital policy that has specifies an aPTT target in this range or an anti-Xa value is a requirement.
No Intervention: Control arm
Participants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.
- Intubation and mortality [ Time Frame: 30 days ]The primary endpoint is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation, or death.
- All-cause mortality [ Time Frame: 30 days and 90 days ]
- Intubation [ Time Frame: 30 days ]Invasive mechanical ventilation
- Hospital-free days [ Time Frame: 30 days ]Days alive outside of the hospital through 30 days following randomization
- ICU-free days [ Time Frame: 30 days ]Number of days alive outside of the ICU through 30 days following randomization
- Ventilator-free days [ Time Frame: 30 days ]Number of days alive without the use of a ventilator through 30 days following randomization.
- Non-invasive ventilation [ Time Frame: 30 days ]The use of non-invasive mechanical ventilation or high flow nasal cannula
- Organ support-free [ Time Frame: 21 days ]Number of days alive without the use of vasopressors/inotropes and ventilation (including high flow nasal cannula >30 L/min and FIO2 >40%) through 21 days following randomization, ranked with death at anytime during 21 days as -1
- Myocardial infarction [ Time Frame: 30 days and 90 days ]
- Ischaemic stroke [ Time Frame: 30 days and 90 days ]
- Venous thromboembolism [ Time Frame: 30 days and 90 days ]
- Major bleeding [ Time Frame: Intervention period (maximum 14 days) ]As defined by the International Society on Thrombosis and Haemostasis (ISTH)
- Heparin-induced thrombocytopenia (HIT) [ Time Frame: Intervention period (maximum 14 days) ]Laboratory-confirmed
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): NCT04372589
|Contact: Ryan Zarychanski, MD, MScemail@example.com|
|Contact: Patrick R. Lawler, MD, MPHfirstname.lastname@example.org|
|Principal Investigator:||Patrick R. Lawler, MD, MPH||Peter Munk Cardiac Centre/University Health Network|
|Principal Investigator:||Ewan C. Goligher, MD, PhD||University Health Network, Toronto|
|Principal Investigator:||Ryan Zarychanski, MD, MSc||University of Manitoba|