Plain English Summary
Background and study aims:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged at the end of 2019 as a novel coronavirus. It has been declared as a global pandemic. Some people develop no symptoms, whilst others develop worsening breathing problems and may die. Throughout the world, a huge burden has been placed on intensive care units due to the number of people with worsening breathing problems that need to be placed on a ventilator (breathing machine). It is essential that we avoid ventilator use wherever possible to allow as many individuals as possible to benefit.
In this trial, we will test whether two treatments are better than standard treatment at preventing people from dying or needing to go on a ventilator.
Who can participate?
Adult patients with suspected or proven COVID-19 admitted to hospital
What does the study involve?
Individuals that have or are believed to have COVID-19 that are requiring a certain amount of oxygen will be randomly allocated to receive one of three interventions. In the first group, participants will be placed on a tight-fitting mask (CPAP). In the second group, participants will receive oxygen blown quickly up their nose by a machine (HFNO). In the third arm, participants will receive standard treatment (a normal oxygen mask). Both CPAP and HFNO are already used routinely in the NHS for other conditions.
Due to the urgency of treatment, we plan to enrol potential participants immediately and seek their consent later. This is because many participants are likely to be confused and due to COVID-19 visiting will be restricted. In addition, for the treatments to be effective, they will need to be started as quickly as possible to have the best outcomes.
We will record the need for people to be placed on a ventilator and death over a 30-day period. We will also see how long people spend on intensive care units and in hospital.
What are the possible benefits and risks of participating?
The planned interventions are already in routine use across NHS Hospitals. The interventions (HFNO and CPAP) may help to reduce the need for patients to go on a ventilator. However, they have some side-effects such as nausea, dryness to the mouth and nose, and pressure sores to the face.
Where is the study run from?
The trial is led by the University of Warwick Clinical Trials Unit
When is the study starting and how long is it expected to run for?
From March 2020 to May 2021
Who is funding the study?
The National Institute for Health Research (UK)
Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.
Sponsor: 26/19-20, IRAS 282338
In adult patients with known or suspected COVID-19, does the use of Continuous Positive Airway Pressure (CPAP) or high-flow nasal oxygen (HFNO), compared with standard care reduce mortality or need for tracheal intubation?
CPAP is superior to standard care in reducing mortality or need for tracheal intubation in COVID-19 patients
HFNO is superior to standard care in reducing mortality or need for tracheal intubation in COVID-19 patients
CPAP is superior to HFNO in reducing mortality or need for tracheal intubation in COVID-19 patients
Approved 03/04/2020, the London - Brighton & Sussex Research Ethics Committee
(Health Research Authority, Ground Floor, Skipton House, 80 London Road, London SE1 6LH; +44 0207 104 8241; email@example.com), ref: 20/HRA/1696
Adaptive (group-sequential), pragmatic, randomised controlled, open-label, multi-centre, effectiveness trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Respiratory failure in patients with known or suspected COVID-19 (SARS-CoV-2 infection)
Patients will be randomised in a 1:1:1 ratio to:
Arm 1: Continuous positive airway pressure (CPAP), administered according to local protocol/guidelines. Administration will be left to clinical discretion.
Arm 2: High flow nasal oxygen (HFNO) will be administered according to local protocol/guidelines. Administration will be left to clinical discretion.
Arm 3: Standard care. Standard oxygen therapy according to local protocol/guidelines.
Primary outcome measure
Composite outcome comprising tracheal intubation or mortality within 30 days. Mortality will be reported from hospital records up until discharge and tracked after discharge. Intubation will be obtained from hospital data.
Secondary outcome measures
All outcome measures are assessed at up to 30-days or hospital discharge, whichever is later, and obtained from hospital records unless otherwise specified.
1. Intubation rate
2. Time to intubation
3. Time to death (mortality), obtained from hospital record or other source
4. Mortality in critical care (level 2/3)
5. Mortality during hospital stay
6. Mortality at 30 days, obtained from hospital record or other source
7. Length of stay in critical care (level 2/3)
8. Length of stay in hospital
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Adults ≥ 18 years
2. Admitted to hospital with suspected or proven COVID-19
3. On 40% oxygen (or greater) with SpO2 <94%
4. Plan for escalation to intubation if needed
Target number of participants
Participant exclusion criteria
1. Planned intubation and mechanical ventilation imminent within 1 hour
2. Known or clinically apparent pregnancy
3. Any absolute contraindication to CPAP or HFNO
4. Decision not to intubate due to ceiling of treatment or withdrawal of care anticipated
5. Equipment for both CPAP and HFNO not available
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Warwick Clinical Trials Unit
Warwick Medical School University of Warwick
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Trial results will be published as soon as data are analysed. Dissemination will include development of lay summaries and publication in a peer-reviewed journal.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)