Clinical Trial Results:
Early thromboprophylaxis in COVID-19 (ETHIC trial): an open label, randomized phase IIIb trial of community-based prophylactic low-molecular-weight heparin (LMWH) versus standard of care (no enoxaparin) in COVID-19 positive patients
Summary
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EudraCT number |
2020-003125-39 |
Trial protocol |
BE GB DE |
Global end of trial date |
30 Nov 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2022
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First version publication date |
13 Oct 2022
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Other versions |
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Summary report(s) |
Clinical Study Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TRI-08892
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04492254 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
TRI
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Sponsor organisation address |
1b Manresa Road , London, United Kingdom, SW3 6LR
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Public contact |
Clinical Operations Lead, Thrombosis Research Institute, +44 02031989898, afernandez@tri-london.ac.uk
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Scientific contact |
Clinical Operations Lead, Thrombosis Research Institute, +44 02031989898, afernandez@tri-london.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Jun 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2021
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To demonstrate the superiority of prophylactic enoxaparin compared to the current standard of care (no enoxaparin) in reducing hospital admission and/or death within 21 days of randomisation in symptomatic individuals with COVID-19 in a community setting
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Sep 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 10
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Country: Number of subjects enrolled |
United Kingdom: 3
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Country: Number of subjects enrolled |
Belgium: 83
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Country: Number of subjects enrolled |
Brazil: 36
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Country: Number of subjects enrolled |
South Africa: 30
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Country: Number of subjects enrolled |
India: 57
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Worldwide total number of subjects |
219
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EEA total number of subjects |
93
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
144
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From 65 to 84 years |
75
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
In the Screening phase patients will be reviewed in order to confirm that they meet inclusion and not exclusion criteria. | ||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
219 | ||||||||||||||||||||||||
Number of subjects completed |
219 | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Enrollment until day 21 (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Clexane | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Clexane | ||||||||||||||||||||||||
Investigational medicinal product name |
Enoxaparine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
40mg once a day if IBM<100 or 40mg twice a day if IBM>100
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Arm title
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Standard of Care | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Standard of Care | ||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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End points reporting groups
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Reporting group title |
Clexane
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Reporting group description |
- | ||
Reporting group title |
Standard of Care
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Reporting group description |
- |
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End point title |
death or hospitalization to 21 days | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
21 days from enrolment
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Statistical analysis title |
Primary outcome of death or hospitalization to 21 | |||||||||
Statistical analysis description |
A log-rank test was used for statistical significance. Data were displayed using Kaplan-Meier curves by treatment. The unadjusted hazard ratio was calculated using a cox proportional hazards model.
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Comparison groups |
Clexane v Standard of Care
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Number of subjects included in analysis |
219
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 219 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From Day 0-enrolment until day 21
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non Serious Adverse Events are collected in the study so because of that none has bee registered |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |