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

NCT ID: NCT04648410

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2023-12-01

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

questionnaire

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

survey

Eligibility Criteria

Inclusion Criteria

• Members of European Society of Intensive Care

Exclusion Criteria

• not members of European Society of Intensive Care

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

assoc.prof.MD,Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Malaska, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Locations

University Hospital Brno

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jan Malaska, MD., Ph.D

Role: CONTACT

jan.malaska@gmail.com

532232009 ext. 00420

Jozef Klučka, assoc.Prof.MD, Ph.D

Role: CONTACT

klucka.jozef@fnbrno.cz

532234696

Facility Contacts

Jan Malaska, MD. Ph.D.

Role: primary

jan.malaska@gmail.com

532232009 ext. 00420

Jozef Klučka, assoc.prof.MD.Ph.D.

Role: backup

klucka.jozef@fnbrno.cz

532234696 ext. 00420

Other Identifiers

ASAP-C study

Identifier Type: -

Identifier Source: org_study_id