COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04760561


Column Value
Trial registration number NCT04760561
Full text link
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04760561

First author
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Sahar Y Othman, A/P

Contact
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

cbcyounes2017@gmail.com

Registration date
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-18

Recruitment status
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 20, 2021, 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 : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: aged 18-75 years old awake non-intubated spontaneously breathing patients confirmed diagnosis of severe covid-19; manifesting as dyspnea with respiratory rate ≥ 30 breaths/min, pulse rate ≥ 100 beats/min, oxygen saturation ≤93%, or partial pressure of arterial oxygen (pao2) to fraction of inspired oxygen (fio2) ratio ≤ 150 mmhg. positive rt-pcr for sars-cov-2 from analysis of nasopharyngeal, oropharyngeal swab, or tracheal secretion specimens and with chest x-ray showing bilateral infiltrations or chest computerized tomographic (ct) images showing exudation or consolidation. requiring supplemental oxygen (nasal cannula, non-invasive cpap, non-rebreathing face mask) capable of adopting a prone posture independently.

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

the presence of any of the following will mean patients are ineligible: life-threatening arrhythmias hemodynamic instability (defined as mean arterial pressure [map] < 65mm hg and use of vasopressors to achieve map > 65 mm hg) altered mental status, intracranial hypertension facial injuries spine or pelvic fractures recent abdominal surgery pregnancy altered mental status and patients needing invasive ventilation.

Number of arms
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Damanhour University

Inclusion age min
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

82

primary outcome
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blood Pressure (BP) mmHg;Heart Rate (HR) (bpm);Oxygenation index;PaO2mmHg;PCO2mmHg;pH;Positive response to prone positioning;Respiratory Rate (RR) (bpm);ROX index;SaO2;SpO2

Notes
Last imported at : Feb. 20, 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 : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1181, "treatment_name": "Self-prone positioning", "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"}]