NCT04397172

Intensive Care Associated Complications and Outcome of Acute Respiratory Distress Syndrome Due to COVID-19

Terminated Last updated 6 December 2023

What this trial tests

trial testing Study Arm in COVID in 48 participants. Terminated before completion.

Timeline

9 April 2020

Primary endpoint
31 October 2023

27 November 2023

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	48
Start date	9 April 2020
Primary completion	31 October 2023
Estimated completion	27 November 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Study Arm

Conditions studied

• COVID — all drugs for COVID →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• Sars-CoV2 — all drugs for Sars-CoV2 →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 18 to 80, any sex, with COVID or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements.

The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development and early diagnosis of critical illness myopathy in COVID-19 associated acute respiratory distress syndrome.
   Rodriguez B, Branca M, Gutt-Will M, Roth M, et al · · 2022 · cited 16× · PMID 35384375 · DOI 10.1002/jcsm.12989
2. Diagnosis of "intensive care unit-acquired weakness" and "critical illness myopathy": Do the diagnostic criteria need to be revised?
   Rodriguez B, Schefold JC, Z'Graggen WJ. · · 2024 · cited 2× · PMID 39282048 · DOI 10.1016/j.cnp.2024.08.002