The prevention of thrombosis is one of many priorities in managing the COVID-19 patients, but there are several complex considerations, especially when examining anticoagulation strategies. General considerations include the dose of anticoagulant, anticoagulant drug/drug class choice, and treatment duration, as well as to whom and when to administer anticoagulation along with the disease spectrum, according to GlobalData, a leading data and analytics company.
Recent data readouts from two studies (the ACTION and RAPID trials) have provided additional insights into the use of heparin in hospitalized COVID-19 patients. According to GlobalData’s Pharma Intelligence Center Clinical Trials Database, as of July 28, there were above 10 unique clinical trials investigating the use of unfractionated heparin (UH) or low molecular weight heparin (LMWH) in COVID-19 patients globally.
Jesse Cuaron, PhD, PPM, Director at GlobalData, comments: “Despite the availability of highly efficacious oral anticoagulants on the market, recent studies suggest that the use of heparin should remain the mainstay anticoagulant strategy for patients hospitalized with COVID-19.”
The ACTION trial is a pragmatic, randomized, open-label (with blinded adjudication), controlled, multicenter study being conducted in Brazil. It investigated the outcomes of full anticoagulation using oral anticoagulants compared to prophylactic anticoagulation for hospitalized adult COVID-19 patients with elevated D-dimer levels. The data has revealed that anticoagulation with Bayer/Johnson & and Johnson’s Xarelto (rivaroxaban) for stable or unstable (UH used initially) patients did not result in improved outcomes. In fact, patients who received the novel oral anticoagulant (NOAC) experienced increased bleeding compared to standard of care prophylactic anticoagulation, which utilizes UH or enoxaparin, a LMWH.
Dr. Cuaron continues: “Overall, this study suggests that an anticoagulation strategy using Xarelto, and possibly any other NOAC in extension, should be avoided in hospitalized COVID-19 patients unless there is an evidence-based indication for their use.”
The RAPID trial is an open-label, randomized, controlled multicenter study. It investigated the outcomes of full anticoagulation (high dose arm) compared to prophylactic anticoagulation (both utilizing UH or LMWH) in hospitalized adult COVID-19 patients with elevated D-dimer levels. The data has revealed that full-dose anticoagulation with UH or LMWH given early to moderately ill hospitalized COVID-19 patients has significantly reduced all-cause death compared to standard of care/prophylactic anticoagulation, despite no significant reductions observed for the primary outcomes (composite of death, invasive mechanical ventilation, non-invasive mechanical ventilation, or intensive care unit admission).
Dr. Cuaron concludes: “Overall, this study suggests that an anticoagulation strategy using a high heparin dose approach is advantageous in hospitalized COVID-19 patients.”