COVID-19PEP-CoVNCT04530435
PEP Flute-selfcare in COVID-19
A study testing PEP flute in people with COVID-19 and SARS-CoV-2, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- PEP flute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive SARS-CoV-2
- Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
- Access to use a smartphone
- Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
- Given informed consent
Who cannot join
- Age < 18 years.
- Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
- Hospitalised patients or citizens living in nursing homes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals
Frederiksberg, 2000
About this study
Official title: PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial
Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.
The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.
The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.
Read the detailed description
It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group.
Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes.
Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400.
Link to detailed protocol paper will be added once published.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- PEP flute
- Keywords
- COVID-19, SARS-CoV-2, Respiratory symptoms, Positive expiratory pressure, Positive expiratory pressure flute, Airway clearance techniques
- Medical subject headings
- COVID-19, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP fluteDevice
Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The participants will be handed three airway resistances equivalent to a resistance of 10-20 cm H2O alongside one PEP flute. Two videos will guide the participants in use of the PEP flute; one with instructions of the rationale and how to use the flute, including how to choose the suitable resistance and one video, which gives instructions of hygienic maintenance.
Participants in the intervention group will be advised to continue use of their PEP flute in the active intervention period of 30 days or at least if they still have respiratory symptoms. They will receive daily text-messages to prompt their reporting and to use the PEP flute according to instructions. Receives: Device: PEP flute |
| Control group | No intervention | The participants in the control group will receive daily text-messages to prompt their reporting of CAT-scores. To avoid attrition of the trial due to early recovery of symptoms, the project manager will call the participants by phone at day 15 to ask them about their present condition (i.e. CAT-score) and address potential concerns of continued participation of the trial. Otherwise, they will only receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported CAT-score (COPD Assessment Test)
CAT-scores will be measured using a telephone administered questionnaire. The CAT-score is validated to evaluate symptoms in COPD patients. Eight items covers symptoms of cough, sputum, chest pain, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour. The eight items sum up to a range of 0-40 with higher scores indicating more respiratory impairment. Although validated for COPD-use, the CAT-scale is considered useful in the present study because several of the items (dyspnoea, cough, fatigue, sputum and pleuritic chest pain) previously have been used as outcome variables in pneumonia studies. The outcome assessment can be taken within + 1 week for the scheduled visit.
Measured: Day 30.
Secondary outcomes (3)
Hospital admissions
Will be obtained from the Danish National Patient Registry, from which also data of comorbidity will be retrieved.
Measured: Up to day 30, 90 and 180.
Use of antibiotics
Will be obtained from the Danish National Prescription Registry.
Measured: Up to day 30, 90 and 180.
Self-reported CAT-score (COPD Assessment Test)
CAT-scores will be measured using a telephone or email-administered questionnaire. The outcome assessment can be taken within + 1 week for the scheduled visit.
Measured: Day 90, Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start6 Oct 2020
- Primary completion29 Mar 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomised, controlled, open-label trial with two parallel groups and a primary endpoint of CAT-score after 30 days of intervention. Randomization lists will be computer-generated using an appropriate statistical software and based upon permuted random blocks. The allocation ratio will be 1:1 stratified for the following baseline conditions: * Sex * Age (≥60 and \<60 years)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Berit Lilienthal Heitmann, Bispebjerg Hospital
- Investigators
- Berit L. Heitmann, Professor, Ph.D, Principal investigator, Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530435
- Sponsor's protocol ID
- 0211-00023B
- Acronym
- PEP-CoV
- Status last verified
- Mar 2022
- First submitted
- 25 Aug 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mollerup A, Henriksen M, Larsen SC, Bennetzen AS, Simonsen MK, Kofod LM, Knudsen JD, Nielsen XC, Weis N, Heitmann BL. Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting. BMJ. 2021 Nov 24;375:e066952. doi: 10.1136/bmj-2021-066952.
PubMed 34819329Mollerup A, Larsen SC, Bennetzen AS, Henriksen M, Simonsen MK, Weis N, Kofod LM, Heitmann BL. PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19. BMJ Open. 2021 Jun 30;11(6):e050582. doi: 10.1136/bmjopen-2021-050582.
PubMed 34193503
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04530435
- Acronym / sponsor ID
- PEP-CoV / 0211-00023B
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, SARS-CoV-2, Respiratory symptoms, Positive expiratory pressure, Positive expiratory pressure flute, Airway clearance techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.
The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.
The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.
Detailed description
It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group.
Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes.
Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400.
Link to detailed protocol paper will be added once published.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomised, controlled, open-label trial with two parallel groups and a primary endpoint of CAT-score after 30 days of intervention. Randomization lists will be computer-generated using an appropriate statistical software and based upon permuted random blocks. The allocation ratio will be 1:1 stratified for the following baseline conditions: * Sex * Age (≥60 and <60 years)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: PEP fluteThe participants will be handed three airway resistances equivalent to a resistance of 10-20 cm H2O alongside one PEP flute. Two videos will guide the participants in use of the PEP flute; one with instructions of the rationale and how to use the flute, including how to choose the suitable resistance and one video, which gives instructions of hygienic maintenance. Participants in the intervention group will be advised to continue use of their PEP flute in the active intervention period of 30 days or at least if they still have respiratory symptoms. They will receive daily text-messages to prompt their reporting and to use the PEP flute according to instructions. |
| Control group | No intervention | –The participants in the control group will receive daily text-messages to prompt their reporting of CAT-scores. To avoid attrition of the trial due to early recovery of symptoms, the project manager will call the participants by phone at day 15 to ask them about their present condition (i.e. CAT-score) and address potential concerns of continued participation of the trial. Otherwise, they will only receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive SARS-CoV-2
- Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
- Access to use a smartphone
- Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
- Given informed consent
Key exclusion criteria (3 listed)
- Age < 18 years.
- Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
- Hospitalised patients or citizens living in nursing homes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP fluteParticipants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position. | Device | Treatment group |
Primary outcome
Self-reported CAT-score (COPD Assessment Test)
Time frame: Day 30.
CAT-scores will be measured using a telephone administered questionnaire. The CAT-score is validated to evaluate symptoms in COPD patients. Eight items covers symptoms of cough, sputum, chest pain, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour. The eight items sum up to a range of 0-40 with higher scores indicating more respiratory impairment. Although validated for COPD-use, the CAT-scale is considered useful in the present study because several of the items (dyspnoea, cough, fatigue, sputum and pleuritic chest pain) previously have been used as outcome variables in pneumonia studies. The outcome assessment can be taken within + 1 week for the scheduled visit.
3 secondary outcomes
Hospital admissions
Time frame: Up to day 30, 90 and 180.
Use of antibiotics
Time frame: Up to day 30, 90 and 180.
Self-reported CAT-score (COPD Assessment Test)
Time frame: Day 90, Day 180.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 34819329Mollerup A, Henriksen M, Larsen SC, Bennetzen AS, Simonsen MK, Kofod LM, Knudsen JD, Nielsen XC, Weis N, Heitmann BL. Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting. BMJ. 2021 Nov 24;375:e066952. doi: 10.1136/bmj-2021-066952.
- Derived from this study: PubMed 34193503Mollerup A, Larsen SC, Bennetzen AS, Henriksen M, Simonsen MK, Weis N, Kofod LM, Heitmann BL. PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19. BMJ Open. 2021 Jun 30;11(6):e050582. doi: 10.1136/bmjopen-2021-050582.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit L. Heitmann, Professor, Ph.D principal investigator
Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP flute in people with COVID-19 and SARS-CoV-2, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported CAT-score (COPD Assessment Test) (time frame: Day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04530435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.