Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Oxygen Deficiency: the COVID STEROID 2 trial

Phase 1

• Conditions: Adult patients with COVID-19 and severe hypoxia.; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; MedDRA version: 21.1Level: PTClassification code 10021143Term: HypoxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003363-25-DK
• Lead Sponsor: Department of Intensive Care, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-17
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

All the following criteria must be fulfilled:
- Aged 18 years or above AND
- Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND
- Use of one of the following:
•Invasive mechanical ventilation OR
•Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR
•Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

We will exclude patients who fulfil any of the following criteria:
- Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID-19
- Use of systemic corticosteroids for COVID-19 for 5 days or more
- Invasive fungal infection
- Active tuberculosis
- Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
- Known hypersensitivity to dexamethasone
- Previously randomised into the COVID STEROID 2 trial
- Informed consent not obtainable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: Not applicable;Primary end point(s): Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28.;Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Number of participants with one or more serious adverse reactions (SARs) at day 28 defined as new episodes of septic shock, invasive fungal infection, clinically important GI bleeding or anaphylactic reaction to IV dexamethasone<br>-All-cause mortality at day 28<br>-All-cause mortality at day 90<br>-Days alive without life support at day 90<br>-Days alive and out of hospital at day 90<br>-All-cause mortality at day 180<br>-HRQoL at day 180 using EQ-5D-5L and EQ-VAS<br>;Timepoint(s) of evaluation of this end point: Day 28; Day 90; Day 180