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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04344730 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-14 |
|
Recruitment status
Last imported at : Feb. 8, 2023, 4 a.m. Source : ClinicalTrials.gov |
Unknown |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Factorial |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥ 18 years admitted to icu within 48 hours confirmed or highly suspected covid-19 infection acute hypoxemic respiratory failure (pao2 <70 mmhg or spo2<90% on room air or tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow >=6l/min) any treatment intended to treat the sars-cov-2 infection in the absence of contraindications (either as a compassionate use or in the context of a clinical trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity). non-inclusion criteria: moribund status pregnancy or breastfeeding long term corticotherapy at a dose of 0.5mg/kg/j or higher active and untreated bacterial, fungal or parasitic infection not written informed consent from the patient or a legal representative if appropriate . if absence a legal representative the patient may be included in emergency procedure hypersensitivity to dexamethasone or to any of the excipients not affiliation to the french social security |
|
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Assistance Publique - Hôpitaux de Paris |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
France |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
550 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
The time to need for mechanical ventilation (MV);The time-to-death from all causes |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1235, "treatment_name": "Standard oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 320, "treatment_name": "Continuous positive airway pressure", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 775, "treatment_name": "Mechanical ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1715, "treatment_name": "Dexamethasone+standard oxygen", "treatment_type": "Corticosteroids+respiratory support", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1475, "treatment_name": "Continuous positive airway pressure (cpap)+dexamethasone", "treatment_type": "Respiratory support+corticosteroids", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1528, "treatment_name": "Dexamethasone+high flow nasal oxygen", "treatment_type": "Corticosteroids+respiratory support", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1622, "treatment_name": "Dexamethasone+mechanical ventilation", "treatment_type": "Corticosteroids+respiratory support", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}] |