Status:
COMPLETED
Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19
Lead Sponsor:
Brno University Hospital
Collaborating Sponsors:
Masaryk University
Vascular surgery, University hospital Královské Vinohrady, Prague
Conditions:
Covid19
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 effectivenes...
Detailed Description
Since December 2019, Covid-19 virus has infected millions of people worldwide. A significant number of patients develop hyperinflammatory state affecting lungs, which may lead to the need of oxygen th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04663555
Start Date
February 2 2021
End Date
February 23 2023
Last Update
March 22 2023
Active Locations (1)
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1
University Hospital Brno
Brno, Czechia, 62500