Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)
Covid19, ARDS
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, ARDS, dexamethasone
Eligibility Criteria
Inclusion criteria:
Subjects will be eligible for the trial if they meet all of the following criteria:
- Adult (≥ 18 years of age) at time of enrolment;
- Present COVID-19 (infection confirmed by RT-PCR or antigen testing);
- Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy;
Moderate or severe ARDS according to Berlin criteria:
- Moderate - PaO2/FiO2 100-200 mmHg;
- Severe - PaO2/FiO2 < 100 mmHg;
- 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:
- Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol);
- Fulfilled criteria for ARDS for ≥ 14 days at enrolment;
- Pregnancy or breastfeeding;
- 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);
- End-of-life decision or patient is expected to die within next 24 hours;
- Decision not to intubate or ceilings of treatment in place;
Immunosuppression and/or immunosuppressive drugs in medical history:
- Systemic immunosuppressive drugs or chemotherapy in the past 30 days;
- Systemic corticosteroids use before hospitalization;
- Any dose of dexamethasone during the present hospital stay for COVID-19 for more than (≥) last 5 days before enrolment;
- Systemic corticosteroids during present hospital stay for other conditions than COVID-19 (e.g. septic shock);
- Present haematological or generalized solid malignancy;
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;
- Cardiac arrest before ICU admission;
- Participation in another interventional trial in the last 30 days.
Sites / Locations
- University Hospital Brno
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DEX 20 mg
DEX 6 mg
Patients in the intervention group after randomization will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10.
Patients in the control group after randomization will receive dexamethasone 6 mg day 1-10.