Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia : Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia

Background: Preliminary results from the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial have reported a reduction in 28-day mortality with low-dose dexamethasone (6 mg) once daily versus no intervention in hospitalised patients with COVID-19; an effect that may have been more pronounced in patients with increasing hypoxia. Yet, higher doses of dexamethasone may be beneficial in patients with non-COVID-19 acute respiratory distress syndrome. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and severe hypoxia, and clinical equipoise exists.Objective: We aim to assess the effects of higher (12 mg) vs lower doses (6 mg) of intravenous dexamethasone on the number of days alive without life-support in adult patients with COVID-19 and severe hypoxia.Design: International, parallel-group, centrally randomised, stratified, blinded, clinical trial.Population: Adult patients with documented COVID-19 receiving at least 10 L/min of oxygen independent of delivery system OR mechanical ventilation.Experimental intervention: Dexamethasone 12 mg once daily for up to 10 days in addition to standard care.Control intervention: Dexamethasone 6 mg once daily for up to 10 days in addition to standard care.Outcomes: The primary outcome is days alive without life support (i.e. mechanical ventilation, circulatory support, or renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions (i.e. anaphylactic reaction to hydrocortisone, new episode of septic shock, invasive fungal infection or clinically important gastrointestinal bleeding) at day 28; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, 90 and 180; and health-related quality of life at day 180.Sample size: A total of 1000 participants will be randomised in order to detect a 15% relative reduction in 28-day mortality combined with a 10% reduction in time on life support among the survivors with a power of 85%..

Medienart:	Klinische Studie

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ClinicalTrials.gov - (2022) vom: 24. Feb. Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 COVID-19 Hypoxia Medical Condition: Covid19, Hypoxia Phase: Phase 3 Recruitment Status: Completed Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: August 12, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 07, 2022, Last updated: March 09, 2022

Study ID:	NCT04509973 RH-ITA-009 2020-003363-25 2020-07-16 H-20051056
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PPN (Katalog-ID):	CTG003485234