Corticosteroids in Severe COVID-19(ASAP-C Study)

Severe COVID-19 Clinical Trial

— ASAP-C  

Official title:

Administration of Systemic Corticosteroids Among Critically Ill Patients With COVID-19: Electronic Survey (ASAP-C Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648410
• Other study ID #: ASAP-C study
• Status: Recruiting
• Start date: February 16, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Jan Malaska, MD., Ph.D
• Phone: 532232009
• Email: jan.malaska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 100 Years

Eligibility

Inclusion Criteria:

• Members of European Society of Intensive Care

Exclusion Criteria:

• not members of European Society of Intensive Care

Related Conditions & MeSH terms

• COVID-19
• Severe COVID-19

Intervention

Other:
• questionnaire
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

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 month