COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04663555

Jan Malaska

Not reported

2020-12-11

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

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.

2

Brno University Hospital

18

100

Czech Republic

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

235

Number of ventilator-free days (VFDs) at 28 days after randomization

None

Phase 4

[{"arm_notes": "20 mg day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10.", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6 mg day 1-10", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]