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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04492254




Registration number
NCT04492254
Ethics application status
Date submitted
22/07/2020
Date registered
30/07/2020

Titles & IDs
Public title
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients
Scientific title
Early Thromboprophylaxis in COVID-19 (ETHIC Trial): an Open Label, Randomized Phase IIIb Trial of Community-based (LMWH) Versus Standard of Care (no Enoxaparin) in COVID-19 Positive Patients
Secondary ID [1] 0 0
2020-003125-39
Secondary ID [2] 0 0
TRI-08892
Universal Trial Number (UTN)
Trial acronym
ETHIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin

Experimental: Enoxaparin - (40 mg o/d if \< 100 kg, 40 mg b/d if = 100 kg)

No intervention: Current standard of care (no enoxaparin) - Standard of care


Treatment: Drugs: Enoxaparin
The treatment provided will be enoxaparin sodium 40mg/0.4 mL. All doses will be provided in pre-filled, single-dose syringes for subcutaneous injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital Admission
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Hospital Admission
Timepoint [2] 0 0
50 days
Primary outcome [3] 0 0
Hospital Admission
Timepoint [3] 0 0
90 days
Primary outcome [4] 0 0
Death
Timepoint [4] 0 0
21 days
Primary outcome [5] 0 0
Death
Timepoint [5] 0 0
50 days
Primary outcome [6] 0 0
Death
Timepoint [6] 0 0
90 days
Secondary outcome [1] 0 0
Bleeding (as defined by ISTH criteria)
Timepoint [1] 0 0
21 and 50 days
Secondary outcome [2] 0 0
Diagnosis of VTE
Timepoint [2] 0 0
21, 50 and 90 days

Eligibility
Key inclusion criteria
* Signed Informed consent
* Confirmed COVID-19 (i.e. symptoms + positive test for SARS-CoV-2)
* Male or female, age = 55 years
* At least two of the following additional risk factors:

Age = 70 years Body mass index > 25 kg/m2 Chronic obstructive pulmonary disease (COPD)* Diabetes* Cardiovascular disease* Corticosteroid use

*Defined as any disease requiring medical intervention or treatment.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications to unfractionated heparin or LMWH
* Recent (<48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours
* Increased risk for bleeding complications
* Pregnant women
* Severe renal impairment (GFR < 30 mL/min)
* Receiving any antiplatelet therapy (with the exception of low dose (=100mg) aspirin) or anticoagulant therapy (e.g. VKA, DOAC)
* Patients participating in an interventional study that is outside the purview of TRI sponsored studies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2021
Sample size
Target
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brasschaat
Country [2] 0 0
South Africa
State/province [2] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Other
Name
Thrombosis Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ajay Kakkar
Address 0 0
Thrombosis Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04492254