drugset / Trial / NCT04345848

Preventing COVID-19 Complications With Low- and High-dose Anticoagulation

NCT04345848

Phase 3 Terminated 160 enrolled University Hospital, Geneva
RandomizedParallel-groupSingle-blindTreatment

Summary

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS. The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.

Timeline

Start
2020-04-28
Primary completion
2021-06-02
Completion
2021-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified Subcutaneous

Indications