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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001448-24 | EudraCT Number |
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Lack of IMP availability - may resume.
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| Name | Class |
|---|---|
| Christian Medical College and Hospital, Ludhiana, India | OTHER |
| Ministry of Health, Ghana | OTHER_GOV |
| University of Lagos, Nigeria | OTHER |
| Kigali University Teaching Hospital |
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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)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (normal practice) | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESP301 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Pneumonia | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aneel Bhangu | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Abuja Teaching Hospital (Spoke) | Gwagwalada | 902101 | Nigeria | |||
| Lagos University Teaching Hospital (Hub) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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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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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| OTHER |
| Hospital Español Veracruz | UNKNOWN |
| Université d'Abomey-Calavi | OTHER |
| University of Witwatersrand, South Africa | OTHER |
| University of Edinburgh | OTHER |
| Istituto Clinico Humanitas | OTHER |
| University of Cape Town | OTHER |
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
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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 | 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 | 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 | Postoperative diagnosis of proven COVID-19 pulmonary complications | 30 days post-surgery |
| Duration of hospital stay | Duration of hospital stay (including time spent in intensive care, time ventilated) | 30 days post-surgery |
| Pulmonary function | Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale | 30 days post-surgery |
| Lagos |
| Nigeria |
| Nnamdi Azikiwe University Teaching Hospital (Spoke) | Nnewi | 435101 | Nigeria |
| University Teaching Hospital of Butare (CHUB) (Spoke) | Butare | Rwanda |
| Kibungo Referral Hospital (Spoke) | Kibungo | Rwanda |
| Kibagabaga Hospital (Spoke) | Kigali | Rwanda |
| University Teaching Hospital of Kigali (Hub) | Kigali | Rwanda |
| Kibogora District Hospital (Spoke) | Kirambo | Rwanda |
| Ruhengeri Referral Hospital (Spoke) | Ruhengeri | Rwanda |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D011024 | Pneumonia, Viral |