Condition category
Respiratory
Date applied
02/04/2020
Date assigned
06/04/2020
Last edited
15/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

Trial website

Contact information

Type

Public

Primary contact

Dr Keith Couper

ORCID ID

http://orcid.org/0000-0003-2123-2022

Contact details

Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
+442476151179
k.couper@warwick.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Sponsor: 26/19-20, IRAS 282338

Study information

Scientific title

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?

Acronym

Recovery-RS

Study hypothesis

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

Ethics approval

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; brightonandsussex.rec@hra.nhs.uk), ref: 20/HRA/1696

Study design

Adaptive (group-sequential), pragmatic, randomised controlled, open-label, multi-centre, effectiveness trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Respiratory failure in patients with known or suspected COVID-19 (SARS-CoV-2 infection)

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

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

30/03/2020

Overall trial end date

05/05/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4002

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

06/04/2020

Recruitment end date

05/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Clinical Trials Unit
Warwick Medical School University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Gibbet Hill Road
Coventry
Coventry
CV4 7AL
United Kingdom
+44 247 652 2746
wmssponsorship@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

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

03/10/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/04/2020: The ethics approval has been added. 14/04/2020: The funder was added and the plain English summary has been updated to reflect this. 03/04/2020: Trial’s existence confirmed by the Health Research Authority.