Severe COVID-19ASAPESICMESAICNCT04866082
Corticosteroids in Severe COVID-19 (ASAP-ESICM/ESAIC Study)
An observational study of Severe COVID-19, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Brief Summary: Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome in coronavirus-2 (SARS-CoV-2) infection are recommended by several guidelines. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe COVID-19
- What is being tested?
- questionnaire
- How many people
- 466 participants
- Where
- 1 siteCzechia
- Study dates
- 30 May 2021to 30 Jun 2022
- Phase
- Observational
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Members of European Society of Intensive Care Members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Who may be able to join
- Members of European Society of Intensive Care (ESICM)
- Members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Who cannot join
- not members of European Society of Intensive Care (ESICM)
- not members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Systemic Corticosteroids Among Critically Ill Patients With COVID-19: Electronic Survey Within European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care Members (ASAP-ESICM/ESAIC Study)
Brief Summary: Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome in coronavirus-2 (SARS-CoV-2) infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of acute respiratory distress syndrome (ARDS). But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing randomized controlled trials (RCTs) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
Read the detailed description
Brief Summary: Administration of systemic corticosteroids for patients with severe forms of SARS-CoV-2 infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of ARDS. But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of WHO working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing RCTs (Randomized Clinical Trials) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
- Conditions
- Severe COVID-19
- Being tested
- questionnaire
- Keywords
- COVID-19, ARDS, corticosteroids, critical care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called electronic survey
Members of European Society of Intensive Care and European Society of ANaesthesiology and Intensive care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS
| Study group | Role | What they receive |
|---|---|---|
| ESICM and ESAIC members | questionnaire - Members of European Society of Intensive Care and European Society of Anaesthesiology and Intensive Care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
Electronic survey will be send to the European Society of intensive care (ESICM) members via email
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start30 May 2021
- Primary completion14 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COVID-19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society of Anaesthesiology and Intensive Care
- Responsible party
- Principal investigator, Jan Malaska, Brno University Hospital
- Investigators
- Jan Malaska, assoc. prof. MD., Ph.D., Study director, Brno University HospitalPetr Stourac, prof.MD.Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866082
- Sponsor's protocol ID
- ASAP-ESICM/ESAIC
- Acronym
- ASAPESICMESAIC
- Status last verified
- Feb 2023
- First submitted
- 26 Apr 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Systemic Corticosteroids Among Critically Ill Patients With COVID-19: Electronic Survey Within European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care Members (ASAP-ESICM/ESAIC Study)
- ClinicalTrials.gov ID
- NCT04866082
- Acronym / sponsor ID
- ASAPESICMESAIC / ASAP-ESICM/ESAIC
- Conditions
- Severe COVID-19
- Keywords
- COVID-19, ARDS, corticosteroids, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society of Anaesthesiology and Intensive Care
- Study start
- 30 May 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Apr 2021 (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.
Brief Summary: Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome in coronavirus-2 (SARS-CoV-2) infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of acute respiratory distress syndrome (ARDS). But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing randomized controlled trials (RCTs) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
Detailed description
Brief Summary: Administration of systemic corticosteroids for patients with severe forms of SARS-CoV-2 infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of ARDS. But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of WHO working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing RCTs (Randomized Clinical Trials) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESICM and ESAIC members | – | Other: questionnairequestionnaire - Members of European Society of Intensive Care and European Society of Anaesthesiology and Intensive Care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of European Society of Intensive Care Members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Key inclusion criteria (2 listed)
- Members of European Society of Intensive Care (ESICM)
- Members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Key exclusion criteria (2 listed)
- not members of European Society of Intensive Care (ESICM)
- not members of European Society of Anaesthesiology and Intensive Care (ESAIC)
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 |
|---|---|---|
| questionnaireAlso: electronic surveyMembers of European Society of Intensive Care and European Society of ANaesthesiology and Intensive care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS | Other | ESICM and ESAIC members |
Primary outcome
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
Time frame: 2 months
Electronic survey will be send to the European Society of intensive care (ESICM) members via email
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 22 Feb 2023.
- 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.
Jan Malaska, assoc. prof. MD., Ph.D. study director
Brno University Hospital
Petr Stourac, prof.MD.Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe COVID-19, run by Brno University Hospital at 1 site in Czechia.
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 2 inclusion and 2 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 22 Feb 2023. 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 Czechia. 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.
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?
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey) (time frame: 2 months). 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 22 Feb 2023.