Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (PROTECT-Surg)

University of Birmingham

Status and phase: Suspended; Phase 3

Conditions: COVID; Severe Acute Respiratory Syndrome; Pulmonary Complications in Surgical Patients

Treatments: Drug: RESP301

Study type: Interventional

Funder types: Other

Identifiers

NCT04386070

RG_20-029 COVID-19

2020-001448-24 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to reduce pulmonary complications in adult patients undergoing abdominal or thoracic surgery in COVID-19 exposed hospital environments. A Trial in Low and Middle Income Countries (LMICs)

Full 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

Enrollment: 6,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,400 participants in 2 patient groups

Control (normal practice)

No Intervention group

Description:

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

RESP301

Experimental group

Description:

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.

Treatment:

Drug: RESP301