COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT02517489

Not reported

Not reported

15/04/2020

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age ≥ 18 years patients affiliated to social security scheme admission to an intensive care unit (icu) or intermediate care unit participating to the trial diagnosis of community- acquired pneumonia (cap) suggested by at least two of the following: cough, purulent sputum, chest pain and dyspnea focal shadowing/infiltrate on chest x-ray or ct-scan diagnosis of community- acquired pneumonia (cap) during the 48 hours post-hospital admission study drug infusion initiated no longer than 24 hours post first severity criterion severity defined by at least one of the following: pneumonia severity index (psi) > 130 (fine class v) patient placed on mechanical ventilation (invasive or not) for acute respiratory failure, with a peep level of 5 cm of water or more patient treated by high-flow oxygen therapy with a fio2 of 50% or more and a p/f ratio less than 300 patient treated by oxygen therapy with a partial rebreathing-mask with a reservoir bag, provided that the pao2 is less than (cf. table): oxygen flow (l/min) 6 7 8 9 10 or more pao2 (mmhg) less than 180 210 240 270 300 patient already treated by antibiotics (at least one dose since admission to hospital) informed consent signed by the patient, its relatives or emergency procedure on the sub-group of patients included with covid19 : diagnosis of covid19 either as certain (pcr) or probable (evocative clinical and radiological features and epidemic context and absence of other microbiological documentation). study drug infusion initiated no longer than 24 hours post first severity criterion ; in case of transfer from another hospital, this period will be prolonged to 48 hours patient receiving the best available treatment as define by up-to-date scientific knowledge

patient treated by vasopressors for septic shock at the time of inclusion clinical history suggesting of aspiration of gastric content patient treated by invasive mechanical ventilation within 14 days before current hospital admission patient treated by antibiotics for a respiratory infection for more than seven days at the admission to the hospital (except if a pathogen resistant to this antibiotics is isolated) history of cystic fibrosis post-obstructive pneumonia patients in which rapid pcr-test is positive for flu active tuberculosis or fungal infection active viral hepatitis or active infection with herpes viruses myelosuppression decision of withholding mechanical ventilation or endotracheal intubation hypersensitivity to corticosteroids patient needing anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason patients under treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days patient already enrolled in another drug trial with mortality as an end-point. if the patient is already participating in another therapeutic trial with a different endpoint, the investigator must verify that inclusion in cape cod can not prejudice it. pregnant or breastfeeding woman patient on judicial protection

2

University Hospital, Tours

18

100

France

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

952

Day 21 failure;Day 28 all causes mortality

None

Phase 3

[{"arm_notes": "Unknow number of participant in the sub-group COVID-19", "treatment_id": 603, "treatment_name": "Hydrocortisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Unknow number of participant in the sub-group COVID-19", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]