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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe COVID-19
• Intervention / Treatment: Other: questionnaire

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jan Malaska, MD., Ph.D; Phone Number: 00420 532232009; Email: jan.malaska@gmail.com
• Study Contact Backup: Name: Jozef Klučka, assoc.Prof.MD, Ph.D; Phone Number: 532234696; Email: klucka.jozef@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno
    • Contact: Jozef Klučka, assoc.prof.MD.Ph.D.; Phone Number: 00420 532234696; Email: klucka.jozef@fnbrno.cz
    • Contact: Jan Malaska, MD. Ph.D.; Phone Number: 00420 532232009; Email: jan.malaska@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Members of European Society of Intensive Care

Description

Inclusion Criteria:

• Members of European Society of Intensive Care

Exclusion Criteria:

• not members of European Society of Intensive Care

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; Other Names: survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Jan Malaska, MD., Ph.D, University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ASAP-C study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No