NCT04344730: COVIDICUS

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia

Status unknown NA Last updated 9 February 2021

What this trial tests

NA trial testing Dexamethasone injection in Acute Hypoxemic Respiratory Failure in 550 participants. Status unknown.

Timeline

10 April 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	550
Start date	10 April 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across France

Drugs / interventions tested

• Dexamethasone injection
• placebo
• conventional oxygen
• CPAP
• HFNO
• mechanical ventilation

Conditions studied

• Acute Hypoxemic Respiratory Failure — all drugs for Acute Hypoxemic Respiratory Failure →
• COVID-19 — all drugs for COVID-19 →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Acute Hypoxemic Respiratory Failure or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.

The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

Publications & conference data

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

1. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.
   WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Sterne JAC, Murthy S, Diaz JV, et al · · 2020 · cited 1746× · PMID 32876694 · DOI 10.1001/jama.2020.17023
2. The vascular endothelium: the cornerstone of organ dysfunction in severe SARS-CoV-2 infection.
   Pons S, Fodil S, Azoulay E, Zafrani L. · · 2020 · cited 352× · PMID 32546188 · DOI 10.1186/s13054-020-03062-7
3. Systemic corticosteroids for the treatment of COVID-19.
   Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
4. How the COVID-19 pandemic will change the future of critical care.
   Arabi YM, Azoulay E, Al-Dorzi HM, Phua J, et al · · 2021 · cited 136× · PMID 33616696 · DOI 10.1007/s00134-021-06352-y
5. Weathering the COVID-19 storm: Lessons from hematologic cytokine syndromes.
   England JT, Abdulla A, Biggs CM, Lee AYY, et al · · 2021 · cited 124× · PMID 32425294 · DOI 10.1016/j.blre.2020.100707
6. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
   Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
7. High-Dose Dexamethasone and Oxygen Support Strategies in Intensive Care Unit Patients With Severe COVID-19 Acute Hypoxemic Respiratory Failure: The COVIDICUS Randomized Clinical Trial.
   Bouadma L, Mekontso-Dessap A, Burdet C, Merdji H, et al · · 2022 · cited 101× · PMID 35788622 · DOI 10.1001/jamainternmed.2022.2168
8. A critical evaluation of glucocorticoids in the management of severe COVID-19.
   Solinas C, Perra L, Aiello M, Migliori E, et al · · 2020 · cited 61× · PMID 32616381 · DOI 10.1016/j.cytogfr.2020.06.012