NCT04386070

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)

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
6,400

participants targeted

Target at P75+ for phase_3

Timeline
10mo left

Started May 2022

Longer than P75 for phase_3

Geographic Reach
2 countries

9 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
May 2022Mar 2027

First Submitted

Initial submission to the registry

April 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4.6 years

First QC Date

April 30, 2020

Last Update Submit

February 18, 2025

Conditions

Pulmonary Complications in Surgical PatientsCOVIDSevere Acute Respiratory Syndrome

Keywords

SurgeryPneumoniaCOVID 19COVIDSARS-Cov-2SARS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Rate of Pneumonia

    From randomisation until discharge from hospital, average less than 30 days

  • Rate of ARDs

    From randomisation until discharge from hospital, average less than 30 days

  • Death rate

    From randomisation until discharge from hospital, average less than 30 days

  • Rate of unexpected ventilation

    From operation until 30 days post operation

  • COVID-19 pulmonary complications

    30 days post-surgery

  • +2 more secondary outcomes

Study Arms (2)

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.

Drug: RESP301

Interventions

RESP301DRUG

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.

RESP301

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Of Abuja Teaching Hospital (Spoke)

Gwagwalada, 902101, Nigeria

Location

Lagos University Teaching Hospital (Hub)

Lagos, Nigeria

Location

Nnamdi Azikiwe University Teaching Hospital (Spoke)

Nnewi, 435101, Nigeria

Location

University Teaching Hospital of Butare (CHUB) (Spoke)

Butare, Rwanda

Location

Kibungo Referral Hospital (Spoke)

Kibungo, Rwanda

Location

Kibagabaga Hospital (Spoke)

Kigali, Rwanda

Location

University Teaching Hospital of Kigali (Hub)

Kigali, Rwanda

Location

Kibogora District Hospital (Spoke)

Kirambo, Rwanda

Location

Ruhengeri Referral Hospital (Spoke)

Ruhengeri, Rwanda

Location

Related Publications (1)

  • 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.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory SyndromePneumoniaCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesLung DiseasesPneumonia, Viral

Study Officials

  • Aneel Bhangu

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 13, 2020

Study Start

May 16, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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).

Locations

NG(3)RW(6)