RECOVERY Respiratory Support: Respiratory Strategies in patients with coronavirus COVID-19 – CPAP, high-flow nasal oxygen, and standard care
| ISRCTN | ISRCTN16912075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16912075 |
| IRAS number | 282338 |
| Secondary identifying numbers | Sponsor: 26/19-20, IRAS 282338 |
- Submission date
- 02/04/2020
- Registration date
- 06/04/2020
- Last edited
- 25/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Current plain English summary as of 04/05/2021:
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 hospital inpatients with suspected or proven COVID-19
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.
Where possible, we will seek informed consent from participants prior to trial enrolment. In some cases, the urgency of treatment may require that participants are enrolled and their consent sought later. This is because some participants are likely to be confused and, due to COVID-19, visiting is restricted. In addition, for treatments to be effective, they will need to be started as quickly as possible to have the best possible 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 June 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.
Previous 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.
Contact information
Public
Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-2123-2022 |
|---|---|
| Phone | +442476151179 |
| k.couper@warwick.ac.uk |
Study information
| Study design | Adaptive (group-sequential), pragmatic, randomised controlled, open-label, multi-centre, effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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? |
| Study 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(s) | 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 |
| 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 |
| 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 | Current secondary outcome measures as of 04/05/2021: 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 9. Duration of invasive ventilation 10. Admission to ICU Previous 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 study start date | 30/03/2020 |
| Overall study end date | 02/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4002 |
| Participant inclusion criteria | Current participant inclusion criteria as of 04/05/2021: 1. Adults ≥18 years 2. Hospital inpatient with suspected or proven COVID-19 3. FiO2 ≥0.4 and SpO2 ≤94% 4. Plan for escalation to intubation if needed Previous 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 exclusion criteria | Current participant exclusion criteria as of 04/05/2021: 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 treatment anticipated 5. Equipment for both CPAP and HFNO not available Previous 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 | 03/05/2021 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
University of Warwick
Coventry
CV4 7AL
United Kingdom
Liverpool
L9 7AL
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Barnet
EN5 3DJ
United Kingdom
Bedford
MK42 9DJ
United Kingdom
Belfast
BT9 7AB
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
London
W6 8RF
United Kingdom
Colchester
CO4 5JL
United Kingdom
St. Leonards-On-Sea
TN37 7RD
United Kingdom
Croydon
CR7 7YE
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Grimsby
DN33 2BA
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Bury
BL9 7TD
United Kingdom
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
Leicester
LE3 9QP
United Kingdom
Sutton Coldfield
B75 7RR
United Kingdom
Harefield
UB9 6JH
United Kingdom
Birmingham
B9 5SS
United Kingdom
Hull
HU3 2JZ
United Kingdom
Greenock
PA16 0XN
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Jersey
JE1 3UH
United Kingdom
Canterbury
CT1 3NG
United Kingdom
London
SE5 9RS
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Walsall
WS2 9PS
United Kingdom
Gillingham
ME7 5NY
United Kingdom
Taunton
TA1 5DA
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Manchester
M8 5RB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
Grainger Drive
Telford
TF1 6TF
United Kingdom
Orpington
BR6 8ND
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Glasgow
G51 4TF
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Paisley
PA2 9PN
United Kingdom
London
SW3 6NP
United Kingdom
Newport
Gwent
NP20 2UB
United Kingdom
Liverpool
L7 8XP
United Kingdom
London
SW3 6JJ
United Kingdom
Sutton
SM2 5PT
United Kingdom
Oldham
OL1 2JH
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Salford
M6 8HD
United Kingdom
Scunthorpe
DN15 7BH
United Kingdom
South Shields
NE34 0PL
United Kingdom
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
London
SW17 0QT
United Kingdom
London
W2 1NY
United Kingdom
London
SE1 7EH
United Kingdom
Stockport
SK2 7JE
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Cwmbran
NP44 8YN
United Kingdom
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Southampton
SO16 6YD
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Warwick
CV34 5BW
United Kingdom
Watford
WD18 0HB
United Kingdom
Bury St. Edmunds
IP33 2QZ
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Wishaw
ML2 0DP
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
University/education
Gibbet Hill Road
Coventry
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 247 652 2746 |
|---|---|
| wmssponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 03/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/07/2020 | 03/08/2020 | Yes | No |
| Preprint results | 04/08/2021 | 31/08/2021 | No | No | |
| Results article | 24/01/2022 | 25/01/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/01/2022: Publication reference added.
31/08/2021: Preprint reference added.
05/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 05/04/2021 to 03/05/2021.
2. The overall trial end date has been changed from 05/05/2021 to 02/06/2021.
3. The secondary outcome measures have been updated.
4. The participant inclusion criteria have been updated.
5. The participant exclusion criteria have been updated.
6. The trial website has been added.
7. The plain English summary has been updated.
8. 75 trial participating centres have been added.
16/03/2021: Internal review.
03/08/2020: Publication reference added.
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.
