Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brno University Hospital
• Collaborators: General University Hospital in Prague; Masaryk University; Military University Hospital Praha; St. Anne's University Hospital Brno; Third Faculty of Medicine Charles University; Tomáš Baťa Regional Hospital; University Hospital Královské Vinohrady; University Hospital Motol Prague; University Hospital Olomouc; University Hospital Ostrava; University Hospital Plzeň; Vascular surgery, University hospital Královské Vinohrady, Prague
• Treatments: Dexamethasone

Criteria

Inclusion criteria:

Subjects will be eligible for the trial if they meet all of the following criteria:

1. Adult (≥ 18 years of age) at time of enrolment;

2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing);

3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy;

4. Moderate or severe ARDS according to Berlin criteria:

• Moderate - PaO2/FiO2 100-200 mmHg;

• Severe - PaO2/FiO2 < 100 mmHg;

5. Admission to ICU in the last 24 hours.

Exclusion criteria:

Subjects will not be eligible for the trial if they meet any of the following criteria:

1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol);

2. Fulfilled criteria for ARDS for ≥ 14 days at enrolment;

3. Pregnancy or breastfeeding;

4. Unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method);

5. End-of-life decision or patient is expected to die within next 24 hours;

6. Decision not to intubate or ceilings of treatment in place;

7. Immunosuppression and/or immunosuppressive drugs in medical history:

1. Systemic immunosuppressive drugs or chemotherapy in the past 30 days;

2. Systemic corticosteroids use before hospitalization;

3. Any dose of dexamethasone during the present hospital stay for COVID-19 for more than (≥) last 5 days before enrolment;

4. Systemic corticosteroids during present hospital stay for other conditions than COVID-19 (e.g. septic shock);

8. Present haematological or generalized solid malignancy;

9. Any of contraindications of corticosteroids, e.g.

• intractable hyperglycaemia;

• active gastrointestinal bleeding;

• adrenal gland disorders;

• a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment;

10. Cardiac arrest before ICU admission;

11. Participation in another interventional trial in the last 30 days.