COVIDPhase 3COVID-HEPNCT04345848
Preventing COVID-19 Complications With Low- and High-dose Anticoagulation
A Phase 3 study testing Enoxaparin in people with COVID and Sars-CoV2, run by University Hospital, Geneva at 4 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 28 Apr 2020to 2 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Geneva University Hospitals
Geneva
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
Ospedale Regionale di Locarno
Locarno
Hôpital du Valais
Sion
About this study
Official title: Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
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.
- Being tested
- Enoxaparin
- Keywords
- anticoagulation, heparin, thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Unfractionated heparin
Two different doses of anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Participants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery. Receives: Drug: Enoxaparin |
| Prophylactic anticoagulation | Active comparator | Participants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care. Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (9)
Arterial thrombosis
Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Measured: 30 days
Venous thromboembolism
Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
Measured: 30 days
Disseminated intravascular coagulation
Risk of DIC
Measured: 30 days
All-cause mortality
Risk of all-cause mortality
Measured: 30 days
Sepsis-induced coagulopathy
Risk of SIC
Measured: 30 days
Acute respiratory distress syndrome
Risk of ARDS
Measured: 30 days
Durations of hospital stay, ICU stay, ventilation
Number of days with these care processes
Measured: 30 days
Sequential organ failure assessment score
Highest score per participant
Measured: 30 days
Clinical deterioration
Risk of clinical deterioration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start28 Apr 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Why it stopped: Low recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Blondon, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345848
- Sponsor's protocol ID
- 2020-00794
- Acronym
- COVID-HEP
- Status last verified
- Sep 2021
- First submitted
- 7 Apr 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
PubMed 33502773Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
PubMed 32407672
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04345848
- Acronym / sponsor ID
- COVID-HEP / 2020-00794
- Keywords
- anticoagulation, heparin, thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitement
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Drug: EnoxaparinParticipants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery. |
| Prophylactic anticoagulation | Active comparator | Drug: EnoxaparinParticipants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinAlso: Unfractionated heparinTwo different doses of anticoagulation | Drug | Prophylactic anticoagulation, Therapeutic anticoagulation |
Primary outcome
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Time frame: 30 days
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
9 secondary outcomes
Arterial thrombosis
Time frame: 30 days
Venous thromboembolism
Time frame: 30 days
Disseminated intravascular coagulation
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Sepsis-induced coagulopathy
Time frame: 30 days
Acute respiratory distress syndrome
Time frame: 30 days
Durations of hospital stay, ICU stay, ventilation
Time frame: 30 days
Sequential organ failure assessment score
Time frame: 30 days
Clinical deterioration
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 35244208Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
- Derived from this study: PubMed 32407672Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin in people with COVID and Sars-CoV2, run by University Hospital, Geneva at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.