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Trial - NCT04821973


Column Value
Trial registration number NCT04821973
Full text link
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Pierre MICHELET

Contact
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

pierre.michelet@ap-hm.fr

Registration date
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-30

Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patient with covid 19 pneumonia assessed by pcr and ct scann. - patient admited in a dedicated medical ward - patient with oxygen supply less or equal to 4 liters per minute. - written informed consent

Exclusion criteria
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- patient with limitation of care. - patient with immediate risk to icu transfer within the first 12 hours - patient with neurological or psychiatric symptoms that interfere with respiratory parameters interpretation. - patient with acute or chronic respiratory disease such as copd, cancer. - pregnancy, age < 18 of vulnerable profile. - patient refusal to participate or previously included in a clinical research trial.

Number of arms
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Assistance Publique Hopitaux De Marseille

Inclusion age min
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

10

Inclusion age max
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

respiratory degradation event 1;respiratory degradation event 2

Notes
Last imported at : April 1, 2021, 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 : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": " ", "treatment_id": 1057, "treatment_name": "Radius ppg tetherless pulse oximetry", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]