Clinical trial NCT04530435: PEP Flute-selfcare in COVID-19
Official title: PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
Respiratory symptoms
Positive expiratory pressure
Positive expiratory pressure flute
Airway clearance techniques
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2020-08-28
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-reported CAT-score (COPD Assessment Test)
timeFrame: Day 30.
Secondary outcomes:
measure: Hospital admissions
timeFrame: Up to day 30, 90 and 180.
measure: Use of antibiotics
timeFrame: Up to day 30, 90 and 180.
measure: Self-reported CAT-score (COPD Assessment Test)
timeFrame: Day 90, Day 180.
Other outcomes:
measure: Serious Adverse Events
timeFrame: During treatment, up to 30 days.
measure: General and respiratory symptoms
timeFrame: Day 30, 90, Day 180.
Locations:
city: Frederiksberg
country: Denmark
facility: Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals
Study officials:
affiliation: Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark
name: Berit L. Heitmann, Professor, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mollerup 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.