Low dose hydrocortisone in patients with COVID-19 and severe oxygen deficiency – the COVID STEROID trial

Low dose hydrocortisone in patients with COVID-19 and severe hypoxia – the COVID STEROID trial - COVID-STEROID trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001395-15-DK

Enrollment

1000

Registered

2020-03-30

Start date

2020-04-06

Completion date

Unknown

Last updated

2021-08-24

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: 23.0 Level: LLT Classification code 10053983 Term: Corona virus 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: Solu-Cortef Product Name: Solu-Cortef Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: hydrocortisone Other descriptive name: HYDROCORTISONE

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) 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 for any other indication than COVID-19 - Invasive mechanical ventilation for more than 48 hours - Invasive fungal infection - Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG - Known hypersensitivity to hydrocortisone - A patient for whom the clinical team has decided not to use invasive mechanical ventilation - Consent not obtainable

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess benefits and harms of low dose IV hydrocortisone versus placebo on patient-important outcome measures 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 benefits and harms of low dose IV hydrocortisone versus placebo on patient-important outcome measures 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

Measure	Time frame
Secondary end point(s): - All-cause mortality at day 28 - Days alive without life support at day 90 - All-cause mortality at day 90 - Number of participants with one or more serious adverse reactions (SARs) at day 14 defined as new episodes of septic shock, invasive fungal infection, clinically important GI bleeding or anaphylactic reaction to IV hydrocortisone - Days alive and out of hospital at day 90 - All-cause mortality at 1 year after randomisation - Health-Related Quality of Life (HRQoL) at 1 year after randomisation using EQ-5D-5L and EQ-VAS ;Timepoint(s) of evaluation of this end point: Day 14; Day 28; Day 90; 1 year	—

Measure

Time frame

Secondary end point(s): - All-cause mortality at day 28 - Days alive without life support at day 90 - All-cause mortality at day 90 - Number of participants with one or more serious adverse reactions (SARs) at day 14 defined as new episodes of septic shock, invasive fungal infection, clinically important GI bleeding or anaphylactic reaction to IV hydrocortisone - Days alive and out of hospital at day 90 - All-cause mortality at 1 year after randomisation - Health-Related Quality of Life (HRQoL) at 1 year after randomisation using EQ-5D-5L and EQ-VAS ;Timepoint(s) of evaluation of this end point: Day 14; Day 28; Day 90; 1 year

—

Countries

Denmark

Contacts

Public ContactClinical Trials Information

Department of Intensive Care, Rigshospitalet

anders.perner@regionh.dk004535458333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026