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Trial - NCT04386070


Column Value
Trial registration number NCT04386070
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04386070

First author
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Donna Smith

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

PROTECT-Surg@trials.bham.ac.uk

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-13

Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Not recruiting

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

Adaptive

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients aged 18 years and over. (this criteria must be made country-specific) - planned to undergo abdominal or thoracic elective or emergency inpatient surgery requiring general anaesthesia. - asymptomatic of covid-19, including patients with: those not tested, negative test results, positive test but no symptoms (to be monitored post-surgery for symptoms) - informed patient consent. - able to operate a vibrating mesh nebuliser, as assessed by the recruiting physician

Exclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

- procedures under local anaesthesia - known history of adverse reaction/contraindication to trial drug - pregnancy and/or lactating patients (including patients undergoing caesarean section) - history of methaemoglobinaemia - patients receiving any type of prescribed nitric oxide-donating agents (e.g. nitroprusside, isosorbide dinitrate, isosorbide mononitrate, naproxcinod, molsidomine and linsidomine) - unable to tolerate use of a nebuliser and/or deemed unlikely to be able to adhere to protocol in view of investigator

Number of arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University of Birmingham

Inclusion age min
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6400

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1562, "treatment_name": "Hydroxychloroquine+lopinavir+ritonavir", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]