Severe COVID-19ASAP-CNCT04648410
Corticosteroids in Severe COVID-19(ASAP-C Study)
An observational study of Severe COVID-19, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In the very beginning of SARS-Co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for… Read more about this study
- Who is it for?
- Ages 28 days to 100 years
- Conditions the study is for
- Severe COVID-19
- What is being tested?
- questionnaire
- How many people
- 2,000 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Feb 2021to 1 Dec 2023
- 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 28 days to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Members of European Society of Intensive Care
Who may be able to join
- Members of European Society of Intensive Care
Who cannot join
- not members of European Society of Intensive Care
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, 62500
Jan Malaska, MD. Ph.D., 532232009 ext. 00420, jan.malaska@gmail.com
Jozef Klučka, assoc.prof.MD.Ph.D., 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: Administration of Systemic Corticosteroids Among Critically Ill Patients With COVID-19: Electronic Survey (ASAP-C Study)
Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In the very beginning of SARS-Co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous data and clinical practice for patients with refractory or severe form of ARDS.
Read the detailed description
Administration of systemic corticosteroids for patients with severe forms of SARS-Co-2 infection are recommended by several guidelines. In the very beginning of SARS-Co-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 at the latest after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, the routine administration of systemic corticosteroids was revisited. However, there are ongoing critical debate of the evidence regarding the dose, administration, timing and type of corticosteroids and ongoing randomized controlled trial (RCT) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. The dynamic of COVID-19 surges, flip-flop of official recommendations within very short period of time and ongoing critical debate could be with possible variations of daily clinical practice regarding using systemic corticosteroids. In an electronic evaluation form that will be send to European Society of Intensive Care (ESICM) Members. The electronic survey will contain 10 question. In the questionnaire the participants will have to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
- Conditions
- Severe COVID-19
- Being tested
- questionnaire
- 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 survey
Members of European Society of Intensive Care will obtain an electronic survey considering their routine clinical practice regarding the administration of systemic corticosteroids among patients with COVID-19 ARDS
| Study group | Role | What they receive |
|---|---|---|
| Members of European Society of Intensive Care | Members of European Society of Intensive Care will obtain an electronic survey considering their routine clinical practice regarding the administration of systemic corticosteroids 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.
Systemic corticosteroids among patients with COVID-19 ARDS practice - questionnaire (electronic survey)
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start16 Feb 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Jan Malaska, MD., Ph.D, Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648410
- Sponsor's protocol ID
- ASAP-C study
- Acronym
- ASAP-C
- Status last verified
- Jul 2023
- First submitted
- 26 Nov 2020
- Last updated
- 27 Jul 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 27 Jul 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 (ASAP-C Study)
- ClinicalTrials.gov ID
- NCT04648410
- Acronym / sponsor ID
- ASAP-C / ASAP-C study
- Conditions
- Severe COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 1 Dec 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.
Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In the very beginning of SARS-Co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous data and clinical practice for patients with refractory or severe form of ARDS.
Detailed description
Administration of systemic corticosteroids for patients with severe forms of SARS-Co-2 infection are recommended by several guidelines. In the very beginning of SARS-Co-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 at the latest after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, the routine administration of systemic corticosteroids was revisited. However, there are ongoing critical debate of the evidence regarding the dose, administration, timing and type of corticosteroids and ongoing randomized controlled trial (RCT) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. The dynamic of COVID-19 surges, flip-flop of official recommendations within very short period of time and ongoing critical debate could be with possible variations of daily clinical practice regarding using systemic corticosteroids. In an electronic evaluation form that will be send to European Society of Intensive Care (ESICM) Members. The electronic survey will contain 10 question. In the questionnaire the participants will have to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Members of European Society of Intensive Care | – | Other: questionnaireMembers of European Society of Intensive Care will obtain an electronic survey considering their routine clinical practice regarding the administration of systemic corticosteroids among patients with COVID-19 ARDS |
Who may qualify
- Ages
- 28 days to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of European Society of Intensive Care
Key inclusion criteria (1 listed)
- Members of European Society of Intensive Care
Key exclusion criteria (1 listed)
- not members of European Society of Intensive Care
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: surveyMembers of European Society of Intensive Care will obtain an electronic survey considering their routine clinical practice regarding the administration of systemic corticosteroids among patients with COVID-19 ARDS | Other | Members of European Society of Intensive Care |
Primary outcome
Systemic corticosteroids among patients with COVID-19 ARDS practice - questionnaire (electronic survey)
Time frame: 1 month
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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, MD., Ph.D principal investigator
Brno University Hospital
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Malaska, MD., Ph.D (532232009 ext. 00420, jan.malaska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic corticosteroids among patients with COVID-19 ARDS practice - questionnaire (electronic survey) (time frame: 1 month). 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 Jul 2023.