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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386070
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : August 31, 2021
Sponsor:
Collaborators:
Christian Medical College and Hospital, Ludhiana, India
Tamale Teaching Hospital, Ghana.
University of Lagos, Nigeria
Kigali University Teaching Hospital
Hospital Español Veracruz
Université d'Abomey-Calavi
University of Witwatersrand, South Africa
University of Edinburgh
Istituto Clinico Humanitas
University of Cape Town
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Pulmonary Complications in Surgical Patients COVID Severe Acute Respiratory Syndrome Drug: RESP301 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial uses a Bayesian adaptive platform design, allowing for termination of arms if their superiority to standard care is established, and addition of new treatment arms. Patients will be randomised 1:1 to (A) Control (normal practice), (B) RESP301
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 14, 2026


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.
Drug: RESP301
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. COVID-19 pulmonary complications [ Time Frame: 30 days post-surgery ]
    Postoperative diagnosis of proven COVID-19 pulmonary complications

  6. Duration of hospital stay [ Time Frame: 30 days post-surgery ]
    Duration of hospital stay (including time spent in intensive care, time ventilated)

  7. Pulmonary function [ Time Frame: 30 days post-surgery ]
    Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386070


Contacts
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Contact: Donna Smith +44 (0)121 415 9103 PROTECT-Surg@trials.bham.ac.uk
Contact: Rachel Lillywhite +44 (0)121 414 4762 PROTECT-Surg@trials.bham.ac.uk

Sponsors and Collaborators
University of Birmingham
Christian Medical College and Hospital, Ludhiana, India
Tamale Teaching Hospital, Ghana.
University of Lagos, Nigeria
Kigali University Teaching Hospital
Hospital Español Veracruz
Université d'Abomey-Calavi
University of Witwatersrand, South Africa
University of Edinburgh
Istituto Clinico Humanitas
University of Cape Town
Investigators
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Principal Investigator: Aneel Bhangu University of Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04386070    
Other Study ID Numbers: RG_20-029 COVID-19
2020-001448-24 ( EudraCT Number )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Birmingham:
Surgery
Pneumonia
COVID 19
COVID
SARS-Cov-2
SARS
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases