COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04349618

Jean-Christophe RICHARD, Pr

j-christophe.richard@chu-lyon.fr

2020-04-16

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - adults aged 18 years or older - ards according to the berlin definition - covid-19 pneumonia confirmed by rt-pcr - acute respiratory failure not fully explained by left ventricular failure or sodium overload - bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules - invasive mechanical ventilation with pao2/fio2 ≤ 150 mm hg and peep ≥ 5 cm h2o with a tidal volume below or equal to 6 ml per kilogram of predicted body weight - continuous intravenous sedation as part of ards treatment

- exclusion criteria related to ards history - ards onset more than 48 hours before inclusion - previous inclusion in present study - exclusion criteria related to ards severity or complications - arterial ph < 7.21 despite respiratory rate set to 35/min at the time of inclusion - patient under any extracorporeal co2 removal technique or ecmo - pneumothorax or bronchopleural fistula - exclusion criteria related to comorbidities - suspected intracranial hypertension - severe chronic obstructive pulmonary disease defined by a gold score ≥ 3 - chronic respiratory failure under home oxygen or non-invasive ventilation - chronic respiratory failure requiring long term oxygen or non-invasive ventilation - obesity with body weight over height ratio greater than 1 kg/cm - sickle cell disease - bone marrow transplant < 6 months - burn injury with extension greater than 30% of body surface area - cirrhosis with child-pugh score c - advance directives to withhold or withdraw life sustaining treatment - exclusion criteria related to legislation - patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies - pregnancy, lactating women - patient under a legal protective measure. - lack of affiliation to social security as required by french regulation - lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)

2

Hospices Civils de Lyon

18

None

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

200

A composite score based on all-cause mortality and the number of ventilator free-days (VFD)

None

Not reported

[{"arm_notes": "", "treatment_id": 1032, "treatment_name": "Protective ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1330, "treatment_name": "Ultra protective ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]