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Trial - NCT04632602


Column Value
Trial registration number NCT04632602
Full text link
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04632602

First author
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Jean-Olivier ARNAUD

Contact
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Christophe GUERVILLY, christophe.guervilly@ap-hm.fr (PI email not reported)

Registration date
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-17

Recruitment status
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - more than 18 years (adult, older adult) - confirmed covid-19 (positive sars-cov-2 rt-pcr at nasopharyngeal swab) - acute respiratory failure with 100 < pao2:fio2< 300 mmhg - spontaneous ventilation with standard oxygen supply or high flow humidified oxygen - written informed consent of the patient

Exclusion criteria
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- contra-indication to prone position including pregnancy - presence of pacemaker - severe hypoxemia with pao2/fio2 < 100 mmhg - evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

Number of arms
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Assistance Publique Hopitaux De Marseille

Inclusion age min
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

20

primary outcome
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.

Notes
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Prone postition then suspine position", "treatment_id": 1751, "treatment_name": "Awake prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Suspine position then prone position", "treatment_id": 1751, "treatment_name": "Awake prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]