COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04363463

Not reported

Not reported

2020-04-27

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - patients aged from 18 to 85 years old - with covid-19 documentation - undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high flow nasal oxygen therapy) - able to move to pp by him/herself or with minimal assistance - written consent - hospitalized in covid medical department for less than 72 hours

- pregnant (positive pregnancy test during screening) or breastfeeding women - patient on long-term oxygen therapy or continuous positive airway pressure (cpap) or non-invasive ventilation (niv) at home - chronic obstructive pulmonary disease (copd) patient stage 3 or 4 - patient with known chronic diffuse interstitial lung disease - patient with neuromuscular pathology - contraindication to the pp (recent thoracic trauma, pneumothorax, orthopaedic fracture preventing mobilization, ...) - deep vein thrombosis of the lower limbs or pulmonary embolism with effective anticoagulation for less than 48 hours - hemodynamic instability (map < 65 mm hg) persisting for more than 1 hour - respiratory rate greater than 40 cycles per minute - excessive use of accessory respiratory muscles (as judged by the clinician) - indication for curative niv (acute pulmonary edema or acute hypercapnic respiratory failure) - intestinal occlusive syndrome - patient unable to protect upper airway - inability to understand french or to follow instructions for the prone position. - person under guardianship - protected majors - not affiliated to french social security - decision not to forgo life sustaining therapy - patient discharged from an intensive care unit and has been treated by invasive or non-invasive mechanical ventilation at 2 pressure levels during the resuscitation stay.

2

Centre Hospitalier Régional d'Orléans

18

85

France;Monaco

Moderate disease at enrollment

3: Moderate disease at enrollment

268

Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups.

None

Not reported

[{"arm_notes": "nan", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]