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

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)

Conditions

• Pulmonary Complications in Surgical Patients
• COVID
• Severe Acute Respiratory Syndrome

Interventions

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.

Sponsors & Collaborators

• Christian Medical College and Hospital, Ludhiana, India

  collaborator OTHER

• Ministry of Health, Ghana

  collaborator OTHER_GOV

• University of Lagos, Nigeria

  collaborator OTHER

• Kigali University Teaching Hospital

  collaborator OTHER

• Hospital Español Veracruz

  collaborator UNKNOWN

• Université d'Abomey-Calavi

  collaborator OTHER

• University of Witwatersrand, South Africa

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• University of Birmingham

  lead OTHER

Principal Investigators

• Aneel Bhangu · University of Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-16

Primary Completion

2026-12-31

Completion

2027-03-01

Countries

• Nigeria
• Rwanda

Study Locations