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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05083130 |
|
Full text link
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
2021-10-19 |
|
Recruitment status
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 20, 2021, 9:03 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 : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - probable or confirmed covid-19 infection according to who criteria - moderate or severe covid-19 respiratory infection according to vietnamese guidelines - requirement for supplemental oxygen therapy |
|
Exclusion criteria
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
- invasive mechanical ventilation, or non-invasive ventilation (niv) with cpap or bipap or imminent need for these - contraindications to prone position (see appendix 5) - pregnancy - severe obesity (bmi >35), - altered level of consciousness (gcs <13) - attending doctor judged prone position to be unsuitable for the patient for any reason - patients in whom there is a decision that care will not be escalated - failure to have informed consent |
|
Number of arms
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Oxford University Clinical Research Unit, Vietnam |
|
Inclusion age min
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Vietnam |
|
Type of patients
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
93 |
|
primary outcome
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
Percentage of participants who require escalation of respiratory therapy |
|
Notes
Last imported at : Oct. 20, 2021, 9:03 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 : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1751, "treatment_name": "Awake prone position", "treatment_type": "Respiratory support", "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"}] |