- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386070
Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (PROTECT-Surg)
Study Overview
Status
Intervention / Treatment
Detailed Description
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC.
Eligible patients will be randomised at the level of the individual in a 1:1 ratio between:
A. Control (normal practice) B. RESP301 6ml mixture of 150mM sodium nitrate, 50mM mannitol and 100mM citric acid, buffered at pH 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Donna Smith
- Phone Number: +44 (0)121 415 9103
- Email: PROTECT-Surg@trials.bham.ac.uk
Study Contact Backup
- Name: Rachel Lillywhite
- Phone Number: +44 (0)121 414 4762
- Email: PROTECT-Surg@trials.bham.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control (normal practice)
Treatment without the trial intervention.
Patients will be treated as per hospital routine practice.
The control arm may change over the course of the trial and will be monitored by the TMG and DMC
|
|
Experimental: RESP301
RESP301 is administered quickly (8-10 minutes) via an easy-to-use, vibrating mesh nebuliser.
The recommended nebulisers used to administer this intervention are available in all participating countries.
The intervention will be administered using a nebuliser according to standard local practice; where permitted for patients to self-administer, a member of the clinical team will ensure that the patient has viewed the intervention administration training video, and will also oversee the patient for the first trial dose to ensure proper administration.
|
RESP301 is a formulation consisting of three agents already used in clinical practice: mannitol, sodium nitrite and citric acid.
Delivered by a vibrating mesh nebuliser three times per day (TID) (at least 4 hours apart), for 7 days.
Each dose of RESP301 is a 6ml admixture of 150mM NaNO2, 50mM mannitol and 100mM citric acid, buffered at pH 5.4.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death
Time Frame: From randomisation until discharge from hospital, average less than 30 days
|
The primary outcome is any one of the following, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death |
From randomisation until discharge from hospital, average less than 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Pneumonia
Time Frame: From randomisation until discharge from hospital, average less than 30 days
|
Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.
|
From randomisation until discharge from hospital, average less than 30 days
|
Rate of ARDs
Time Frame: From randomisation until discharge from hospital, average less than 30 days
|
ARDs will be presented and analysed separately as a secondary outcome measure
|
From randomisation until discharge from hospital, average less than 30 days
|
Death rate
Time Frame: From randomisation until discharge from hospital, average less than 30 days
|
Death will be presented and analysed separately as a secondary outcome measure
|
From randomisation until discharge from hospital, average less than 30 days
|
Rate of unexpected ventilation
Time Frame: From operation until 30 days post operation
|
Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery
|
From operation until 30 days post operation
|
COVID-19 pulmonary complications
Time Frame: 30 days post-surgery
|
Postoperative diagnosis of proven COVID-19 pulmonary complications
|
30 days post-surgery
|
Duration of hospital stay
Time Frame: 30 days post-surgery
|
Duration of hospital stay (including time spent in intensive care, time ventilated)
|
30 days post-surgery
|
Pulmonary function
Time Frame: 30 days post-surgery
|
Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale
|
30 days post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aneel Bhangu, University of Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG_20-029 COVID-19
- 2020-001448-24 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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