Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19

• Status: Not yet recruiting
• Trial end date: 2026-05-14
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: Christian Medical College and Hospital, Ludhiana, India; Hospital Español Veracruz; Istituto Clinico Humanitas; Kigali University Teaching Hospital; Tamale Teaching Hospital, Ghana.; Université d'Abomey-Calavi; University of Cape Town; University of Edinburgh; University of Lagos, Nigeria; University of Witwatersrand, South Africa
• Treatments: Hydroxychloroquine; Lopinavir; Ritonavir

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