Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202109525822452 Date of Approval: 28/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
Official scientific title Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
Brief summary describing the background and objectives of the trial Research done globally so far indicates that during the COVID-19 pandemic non-invasive ventilation has been crucial in the treatment of patients with moderate to severe symptoms, reducing the need for invasive ventilation and intensive care admission. Oxygen enriched continuous positive airway pressure (CPAP) has also been demonstrated as a suitable treatment for other respiratory diseases, such as pneumonia. However, existing ventilators systems are not designed for cost and resource efficiency which may preclude their use in resource-limited contexts. The purpose of this study is to evaluate the clinical effectiveness in the delivery of continuous positive airway pressures of the LeVe CPAP among Covid-19 pneumonia patients versus the standard Airvo CPAP. And to demonstrate that the LeVe CPAP Flow Generator system is non inferior in the delivery of continuous positive air pressure among patients among patients with COVID-19 hypoxaemic respiratory failure (oxygen saturation below 88% on room air)”
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
Publication URL URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Crossover Trial 6 hourly for a maximum of 12 hours 12 hours The participants will receive their first allocated treatment device for 6 hours before a rest period of up to one hour (using reservoir-bag oxygen) which will give them a chance to eat and drink. They will then continue on the first treatment for another 6 hours for a total of 12 hours on that treatment 40
Control Group CrossOver Trial 6 hourly for a total of 12 hours 12 hours They will then proceed to the second treatment ( Control) for 6 hours before another rest period, and then another 6 hours on that treatment. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Positive for SARS COV 2 Age > 18 years SPO2 at <88% on room air FI02 >70 Failure to obtain consent /Refusal to participate Semi/unconscious/ critically ill Mental confusion Patient with severe oral ulceration Contraindication to CPAP such as Chronic Obstructive Airway Disease (COPD) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/07/2021 Mengo Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
169 Sir Albert Cook Raod Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean difference of Oxygen saturation measured as SP02 from baseline to 6 hours with a non-inferiority margin of 1 to 2% 6 hours from the start of the intervention
Secondary Outcome • Relative effects on heart rate • Blood pressure • Dyspnea/ respiratory rate, • Comfort, and tolerance measured as frequency of breaks from the device. 6 hours from the start of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mengo Hospital 169 Sir Albert Cook Road Kampala 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Leeds University Woodhouse, Leeds LS2 9JT, United Kingdom Leeds 44 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Leeds Woodhouse, Leeds LS2 9JT, United Kingdom Leeds 44 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Medical Aid International Units 1-3 Firs Farm Stagsden Bedfrodshire MK43 8TW United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edith Namulema edith.namulema@mengohospital.org 256772460792 169 Sir Albert Cook Road
City Postal code Country Position/Affiliation
Kampala 256 Uganda Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Gorreti Nampiina gorret.nampiina@mengohospital.org 2560777842848 169 Sir Albert Cook Road
City Postal code Country Position/Affiliation
Kampala 256 Uganda Anesthesiologist
Role Name Email Phone Street address
Public Enquiries Peter Culmer p.r.culmer@leeds.ac.uk 441133432141 Leeds LS2 9JT
City Postal code Country Position/Affiliation
Leeds 00000 Uganda Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial will be de identification and thereafter shared. The study protocol statistical analysis plan, analytical codes and the informed consent will be available for review Data will be available 12 months following publication from the University of Leeds. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available 12 months following publication from the University of Leeds. Results will be available on request from the investigators at the University of Leeds.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
University of Leeds No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information