COVID-19Phase 3NCT05195242
The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19
A Phase 3 study testing Dexamethasone in people with COVID-19 and Thrombosis Embolism, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Thrombosis Embolism, Bleeding
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteSweden
- Study dates
- 27 Aug 2020to 30 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- confirmed SARS-CoV-2 AND
- requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND
- randomised in the ICU
Who cannot join
- if previously randomised to the CS2 trial
- if they had received corticosteroids for COVID-19 during ≥5 consecutive days or use corticosteroids in doses >6 mg dexamethasone for an indication other than COVID-19.
- active tuberculosis
- hypersensitivity to dexa-/betamethasone
- active fungal infection
- fertile woman ≤60 years of age with a positive U-HCG/P-HCG test
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- informed consent not obtainable
- For the inclusion in this post-hoc analyses there is additional criteria:
- established thromboembolism at randomisation
- established major bleeding at randomisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19 - a Post-hoc Analysis of the Blinded, Randomized COVID STEROID 2 Trial
Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.
- Conditions
- COVID-19, Thrombosis Embolism, Bleeding
- Being tested
- Dexamethasone
- Medical subject headings
- COVID-19, Embolism and Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexavit
ATC code H02AB02
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 12 mg | Experimental | Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available. Receives: Drug: Dexamethasone |
| Dexamethasone 6 mg | Active comparator | Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients discharged alive from the ICU without thromboembolic events
Number of patients discharged alive from the ICU without thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events
Measured: During ICU-stay
Secondary outcomes (3)
The cumulative proportion of thromboembolic events
The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events
Measured: During ICU-stay
The cumulative proportion of bleeding events
The cumulative proportion of bleeding events defined as any type of bleeding
Measured: During ICU-stay
The cumulative proportion of major bleeding events
The cumulative proportion of major bleeding event (defined as bleeding requiring transfusion of at least 2 units of Red Blood Cells (RBC) and/or intracranial bleeding and/or bleeding resulting in need for major therapeutic intervention
Measured: During ICU-stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start27 Aug 2020
- Primary completion20 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Scandinavian Critical Care Trials Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet, Linkoeping University, Stockholm South General Hospital
- Responsible party
- Principal investigator, Sandra Jonmarker, Karolinska Institutet
- Investigators
- Rebecka Rubenson Wahlin, MD. PhD, Study director, Karolinska Institutet SödersjukhusetMaria Cronhjort, MD PhD, Study chair, Karolinska Institutet Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195242
- Sponsor's protocol ID
- Thromboembolism COVIDSTEROID2
- Status last verified
- Jun 2022
- First submitted
- 13 Jan 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19 - a Post-hoc Analysis of the Blinded, Randomized COVID STEROID 2 Trial
- ClinicalTrials.gov ID
- NCT05195242
- Acronym / sponsor ID
- Thromboembolism COVIDSTEROID2
- Conditions
- COVID-19, Thrombosis Embolism, Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Scandinavian Critical Care Trials Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet, Linkoeping University, Stockholm South General Hospital
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Jan 2022 (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.
Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 12 mg | Experimental | Drug: DexamethasoneIntravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available. |
| Dexamethasone 6 mg | Active comparator | Drug: DexamethasoneIntravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed SARS-CoV-2 AND
- requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND
- randomised in the ICU
Key exclusion criteria (10 listed)
- if previously randomised to the CS2 trial
- if they had received corticosteroids for COVID-19 during ≥5 consecutive days or use corticosteroids in doses >6 mg dexamethasone for an indication other than COVID-19.
- active tuberculosis
- hypersensitivity to dexa-/betamethasone
- active fungal infection
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 |
|---|---|---|
| DexamethasoneAlso: DexavitATC code H02AB02 | Drug | Dexamethasone 12 mg, Dexamethasone 6 mg |
Primary outcome
Number of patients discharged alive from the ICU without thromboembolic events
Time frame: During ICU-stay
Number of patients discharged alive from the ICU without thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events
3 secondary outcomes
The cumulative proportion of thromboembolic events
Time frame: During ICU-stay
The cumulative proportion of bleeding events
Time frame: During ICU-stay
The cumulative proportion of major bleeding events
Time frame: During ICU-stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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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.
Rebecka Rubenson Wahlin, MD. PhD study director
Karolinska Institutet Södersjukhuset
Maria Cronhjort, MD PhD study chair
Karolinska Institutet Södersjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with COVID-19 and Thrombosis Embolism, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients discharged alive from the ICU without thromboembolic events (time frame: During ICU-stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2022.