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Trial - NCT05407597


Column Value
Trial registration number NCT05407597
Full text link
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05407597

First author
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Joe Kidney, MD

Contact
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

joe.kidney@belfasttrust.hscni.net

Registration date
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

2022-06-07

Recruitment status
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 8, 2022, 3:30 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 : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age >18 years. documented evidence of covid-19 and symptom onset of 7 days or less acute hypoxia which will be defined as either low resting saturations <94% or supplementary oxygen to maintain oxygen saturations at >94%

Exclusion criteria
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

patients known to be pregnant or breastfeeding. patients with unstable ischaemic heart disease or acute stroke patients enrolled in other clinical trials of an investigational medicine within the previous 28 day period patients who refuse to have blood samples taken. known hypersensitivity to icatibant patients who at time of consent are likely to require imminent non-invasive/ invasive ventilatory support or patients already established on continuous positive airway pressure (cpap). patients with chronic heart or lung disease whose oxygen levels are reduced, but are unchanged from baseline

Number of arms
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Belfast Health and Social Care Trust

Inclusion age min
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

United Kingdom

Type of patients
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

32

primary outcome
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Change in Oxygenation

Notes
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 621, "treatment_name": "Icatibant", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]