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

COVID Clinical Trial

— COVID-HEP  

Official title:

Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04345848
• Other study ID #: 2020-00794
• Status: Terminated
• Phase: Phase 3
• Start date: April 28, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: adult patient with COVID-19 infections, admitted to:

• an acute non-critical medical ward with admission D-dimer levels >1,000ng/mL, or
• an acute critical ward (ICU, intermediate care unit)

Exclusion Criteria:

• ongoing or planned therapeutic anticoagulation for any other indication
• contra-indication to therapeutic anticoagulation
• hypersensitivity to heparin
• personal history of heparin-induced thrombocytopenia
• suspected or confirmed bacterial endocarditis
• bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder
• organic lesion prone to bleeding
• platelet count <50G/L, Hb level <80g/L
• ongoing or recent (<30 days) major bleeding, ischemic stroke, trauma, surgery
• use of dual antiplatelet therapy
• pregnancy
• bodyweight <40kg or >150kg.
• end of life care setting
• unwillingness to consent
• ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention

Related Conditions & MeSH terms

• COVID
• Sars-CoV2
• Thrombosis

Intervention

Drug:
• Enoxaparin
Two different doses of anticoagulation

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	Ospedale Regionale di Locarno	Locarno
Switzerland	Hôpital du Valais	Sion

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	Risk of ISTH-defined major bleeding	30 days
Other	Clinically relevant non-major bleeding	Risk of ISTH-defined CRNMB	30 days
Other	Heparin-induced thrombocytopenia	Risk of documented HIT	30 days
Other	PaO2/FiO2 index	Measures of PaO2/FiO2 among participants with mechanical ventilation	30 days
Primary	Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality	Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality	30 days
Secondary	Arterial thrombosis	Risk of ischemic stroke, myocardial infarction and/or limb ischemia	30 days
Secondary	Venous thromboembolism	Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis	30 days
Secondary	Disseminated intravascular coagulation	Risk of DIC	30 days
Secondary	All-cause mortality	Risk of all-cause mortality	30 days
Secondary	Sepsis-induced coagulopathy	Risk of SIC	30 days
Secondary	Acute respiratory distress syndrome	Risk of ARDS	30 days
Secondary	Durations of hospital stay, ICU stay, ventilation	Number of days with these care processes	30 days
Secondary	Sequential organ failure assessment score	Highest score per participant	30 days
Secondary	Clinical deterioration	Risk of clinical deterioration	30 days