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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003363-25-DK

Enrollment

1000

Registered

2020-07-17

Start date

2020-08-18

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with COVID-19 and severe hypoxia. MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862 MedDRA version: 21.1 Level: PT Classification code 10021143 Term: Hypoxia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Dexavit Product Name: Dexavit Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone CAS Number: 312-93-6 Other descriptive name: DEXAMETHASONE PHOSPHATE Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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 - All-cause mortality at day 28 - All-cause mortality at day 90 - Days alive without life support at day 90 - Days alive and out of hospital at day 90 - All-cause mortality at day 180 - HRQoL at day 180 using EQ-5D-5L and EQ-VAS ;Timepoint(s) of evaluation of this end point: Day 28; Day 90; Day 180	—

Measure

Time frame

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 - All-cause mortality at day 28 - All-cause mortality at day 90 - Days alive without life support at day 90 - Days alive and out of hospital at day 90 - All-cause mortality at day 180 - HRQoL at day 180 using EQ-5D-5L and EQ-VAS ;Timepoint(s) of evaluation of this end point: Day 28; Day 90; Day 180

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Countries

Denmark, India, Sweden

Contacts

Public ContactClinical Trials Information

Department of Intensive Care, Rigshospitalet

covid-steroid@cric.nu+4535457237

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026